Wellness Self-Management

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01676909
• Collaborator: (none)
• Enrollment: 262
• Locations: 2
• Arms: 2
• Actual Duration (Months): 39
• Patients Per Site: 131
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care.

Condition or Disease	Intervention/Treatment	Phase
Mental Illness; Chronic Medical Illness	Behavioral: Living Well; Behavioral: Medical Illness Education & Support Group	N/A

Detailed Description

Background:

Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care.

Aims:

Primary AIM 1: Complete a randomized controlled effectiveness trial of the Living Well intervention with 242 Veterans with mental illness and at least one co-occurring chronic medical condition and evaluate the intervention's effects on functional and service related outcomes. The investigators hypothesize that those randomized to the Living Well intervention will, in comparison to those randomized to a medical illness education and support group, demonstrate improved general health functioning including physical and emotional functioning as well as reduced rates of medical emergency room visits for management of a chronic medical condition. The investigators will also evaluate intervention effects on more proximal attitudinal and behavioral outcomes and assess how these factors mediate improvement in the functional and services related outcomes.

Primary AIM 2: Complete a well specified process evaluation based on the RE-AIM evaluation framework to better understand contextual factors that can improve the Reach, Effectiveness, Adoption, Implementation and Maintenance which together determine the potential public health impact of the Living Well intervention.

Methods:

A mix of temporally overlapping quantitative and qualitative methods will be used to maximize integration and synthesis of data streams across the two aims to optimize knowledge accrual.

Impact:

Despite the growing recognition that self-management strategies hold enormous promise for improving quality and outcomes of care for chronic medical illnesses, and the fact that self-management is gaining prominence as a mental health recovery oriented treatment focus, there are currently no evidence-based peer facilitated medical illness self-management interventions available for dissemination within the VA mental health system. The proposed study is designed to both generate evidence supporting the effectiveness of a peer co-facilitated intervention and to help speed throughput to public health impact by collecting important contextual information about factors that may improve future dissemination and implementation efforts.

Study Design

• Study Type: Interventional
• Actual Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Health Services Research
• Official Title: A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Living Well This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. After completing the 12 weekly groups, participants will return to complete once monthly booster group sessions for the next three months.	Behavioral: Living Well; This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
Active Comparator: Medical Illness Education & Support Group We selected a comparison condition that would provide parallel focus (i.e. medical illness) but not include use of the core ingredients undergirding the Living Well intervention including behavioral action planning, problem solving, in-session and between session practice using specific disease self-management techniques and involvement of peer co-facilitators to enhance modeling and improve self-efficacy and activation. As with Living Well, the content of the intervention will have broad applicability across diverse chronic disease conditions. The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition.	Behavioral: Medical Illness Education & Support Group; The comparison condition will be a general Medical Illness Education and Support (MIES) group that will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions that also meets for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Short Form-12 (SF-12) General Health (Norm Based) [Baseline, Post-intervention (3 months after baseline)]

   12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

2. Short-Form 12 (SF-12) Physical Scale (Norm Based) [Baseline, Post-intervention (3 months after baseline)]

   12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

3. Short-Form 12 (SF-12) Mental Scale (Norm Based) [Baseline, Post-intervention (3 months after baseline)]

   12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

4. ER Visit Between Baseline and the 6-month Follow-up [Baseline, Follow-up (6-months after baseline)]

   Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.

Secondary Outcome Measures

1. Illness Management Self-Efficacy [Baseline, Post-intervention (3 months after baseline)]

   This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.

2. Patient Activation Measure [Baseline, Post-intervention (3 months after baseline)]

   This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.

3. Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale [Baseline, Post-intervention (3 months after baseline)]

   This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.

4. Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale [Baseline, Post-intervention (3 months after baseline)]

   This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.

5. Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale [Baseline, Post-intervention (3 months after baseline)]

   This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.

6. Measure of Self-Management Behaviors - Accessing Social Support Subscale [Baseline, Post-intervention (3 months after baseline)]

   This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.

7. Measure of Self-Management Behaviors - Physical Activity Subscale [Baseline, Post-intervention (3 months after baseline)]

   This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.

8. Measure of Self-Management Behaviors - Healthy Eating Subscale [Baseline, Post-intervention (3 months after baseline)]

   This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.

9. Short Form-12 (SF-12) General Health (Norm Based) [Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)]

   12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

10. Short-Form 12 (SF-12) Physical Scale (Norm Based) [Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)]

    12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

11. Short-Form 12 (SF-12) Mental Scale (Norm Based) [Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)]

    12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

12. Illness Management Self-Efficacy [Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)]

    This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.

13. Patient Activation Measure [Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)]

    This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity

14. Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale [Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)]

    This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.

15. Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale [Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)]

    This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.

16. Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale [Baseline, Post-Intervention, Follow-up (6 months after baseline)]

    This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.

17. Measure of Self-Management Behaviors - Accessing Social Support Subscale [Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)]

    This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.

18. Measure of Self-Management Behaviors - Physical Activity Subscale [Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)]

    This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.

19. Measure of Self-Management Behaviors - Healthy Eating Subscale [Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)]

    This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.

Other Outcome Measures

1. Morisky Medication Adherence Scale [Baseline, Post-intervention (3 months after baseline)]

   This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.

2. Multidimensional Health Locus of Control (HLOC) [Baseline, Post-intervention (3 months after baseline)]

   Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.

3. Maryland Assessment of Recovery Scale (MARS) [Baseline, Post-intervention (3 months after baseline)]

   The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.

4. Morisky Medication Adherence Scale [Baseline, Follow-up (6 months after baseline)]

   Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.

5. Multidimensional Health Locus of Control (HLOC) [Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)]

   Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.

6. Maryland Assessment of Recovery Scale (MARS) [Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)]

   The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• a diagnosis of schizophrenia/ schizoaffective disorder

• bipolar disorder

• major depression with psychotic features

• post traumatic stress disorder

• or psychosis not otherwise specified (NOS)

• age between 18 and 80

• chart documented presence of at least one of the following chronic medical conditions:

• a respiratory condition (e.g. asthma, COPD)

• diabetes

• arthritis

• cardiovascular condition (e.g. congestive heart failure, hypertension, etc.)

• receiving mental health services at a designated study site

• willing and able to provide consent to participate

• deemed clinically stable enough to participate in the study by a treatment provider

Exclusion Criteria:

• Severe or profound mental retardation

• Because participants must be able to attend the intervention if assigned to either condition, we will also require potential participants to verify their availability during screening

• Participation in current ongoing study 'Reducing Internalized Stigma in People with Serious Mental Illness"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington DC VA Medical Center, Washington, DC	Washington	District of Columbia	United States	20422
2	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Richard W Goldberg, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Documents (Full-Text)

• Study Protocol - May 1, 2015

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01676909
• Other Study ID Numbers: IIR 11-276
• First Posted: Aug 31, 2012
• Last Update Posted: Jun 6, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: self-management
• Additional relevant MeSH terms: Mental Disorders

Study Results

Participant Flow

Pre-assignment Detail	262 participants were enrolled in the study prior to randomization. 20 participants were not able to be randomized due to attrition resulting in a final study sample of 242.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Period Title: Overall Study
STARTED	124	118
Post-Treatment Assessment	105	107
COMPLETED	106	104
NOT COMPLETED	18	14

Baseline Characteristics

Arm/Group Title	Living Well	Medical Illness Education and Support Group	Total
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.	Total of all reporting groups
Overall Participants	124	118	242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.5 (7.6)	57.0 (7.8)	57.8 (7.7)
Sex: Female, Male (Count of Participants)
Female	17 13.7%	15 12.7%	32 13.2%
Male	107 86.3%	103 87.3%	210 86.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 3.2%	1 0.8%	5 2.1%
Not Hispanic or Latino	118 95.2%	117 99.2%	235 97.1%
Unknown or Not Reported	2 1.6%	0 0%	2 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	82 66.1%	69 58.5%	151 62.4%
White	31 25%	38 32.2%	69 28.5%
More than one race	11 8.9%	11 9.3%	22 9.1%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Short Form-12 (SF-12) General Health (Norm Based)
Description	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	40.4 (12.0)	38.9 (12.5)
Post-intervention	42.5 (11.3)	41.6 (12.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.362
	Comments
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Short-Form 12 (SF-12) Physical Scale (Norm Based)
Description	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	39.2 (10.4)	38.6 (11.4)
Post-intervention	39.0 (10.3)	40.2 (11.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	Mixed Models Analysis
	Comments

3. Primary Outcome

Title	Short-Form 12 (SF-12) Mental Scale (Norm Based)
Description	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	41.3 (11.9)	40.7 (11.5)
Post-intervention	44.0 (11.4)	40.5 (11.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	Mixed Models Analysis
	Comments

4. Primary Outcome

Title	ER Visit Between Baseline and the 6-month Follow-up
Description	Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
Time Frame	Baseline, Follow-up (6-months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	49 39.5%	45 38.1%
6 month follow-up	47 37.9%	48 40.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.64
	Comments
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

Title	Illness Management Self-Efficacy
Description	This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	5.5 (2.1)	5.5 (2.0)
Post-intervention	6.2 (1.9)	5.4 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

Title	Patient Activation Measure
Description	This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	60.8 (15.2)	58.8 (14.6)
Post-intervention	64.3 (14.0)	58.9 (14.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments
	Method	Mixed Models Analysis
	Comments

7. Secondary Outcome

Title	Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.7 (1.1)	2.3 (1.2)
Post-intervention	2.9 (1.2)	2.6 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.544
	Comments
	Method	Mixed Models Analysis
	Comments

8. Secondary Outcome

Title	Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.9 (1.4)	2.5 (1.4)
Post-intervention	3.3 (1.2)	2.9 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.699
	Comments
	Method	Mixed Models Analysis
	Comments

9. Secondary Outcome

Title	Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.2 (1.1)	2.2 (1.0)
Post-intervention	2.5 (1.0)	2.2 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Mixed Models Analysis
	Comments

10. Secondary Outcome

Title	Measure of Self-Management Behaviors - Accessing Social Support Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.3 (1.4)	2.3 (1.2)
Post-intervention	2.4 (1.3)	2.4 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.762
	Comments
	Method	Mixed Models Analysis
	Comments

11. Secondary Outcome

Title	Measure of Self-Management Behaviors - Physical Activity Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.3 (1.3)	2.3 (1.3)
Post-intervention	2.7 (1.3)	2.4 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.326
	Comments
	Method	Mixed Models Analysis
	Comments

12. Secondary Outcome

Title	Measure of Self-Management Behaviors - Healthy Eating Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.6 (1.3)	2.5 (1.3)
Post-intervention	3.0 (1.1)	2.7 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.667
	Comments
	Method	Mixed Models Analysis
	Comments

13. Secondary Outcome

Title	Short Form-12 (SF-12) General Health (Norm Based)
Description	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	40.4 (12.0)	38.9 (12.5)
Post-intervention	42.5 (11.3)	41.6 (12.2)
Follow-up	42.9 (12.0)	39.2 (12.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.142
	Comments
	Method	Mixed Models Analysis
	Comments

14. Secondary Outcome

Title	Short-Form 12 (SF-12) Physical Scale (Norm Based)
Description	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	39.2 (10.4)	38.6 (11.4)
Post-intervention	39.0 (10.3)	40.2 (11.3)
Follow-up	40.3 (10.2)	38.4 (12.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.342
	Comments
	Method	Mixed Models Analysis
	Comments

15. Secondary Outcome

Title	Short-Form 12 (SF-12) Mental Scale (Norm Based)
Description	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	41.3 (11.9)	40.7 (11.5)
Post-intervention	44.0 (11.4)	40.5 (11.6)
Follow-up	42.7 (11.5)	41.5 (12.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.563
	Comments
	Method	Mixed Models Analysis
	Comments

16. Secondary Outcome

Title	Illness Management Self-Efficacy
Description	This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	5.5 (2.1)	5.5 (2.0)
Post-intervention	6.2 (1.9)	5.4 (2.1)
Follow-up	6.0 (2.0)	5.4 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments

17. Secondary Outcome

Title	Patient Activation Measure
Description	This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	60.8 (15.2)	58.8 (14.6)
Post-intervention	64.3 (14.0)	58.9 (14.3)
Follow-up	63.4 (14.6)	60.5 (16.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.727
	Comments
	Method	Mixed Models Analysis
	Comments

18. Secondary Outcome

Title	Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.7 (1.1)	2.3 (1.2)
Post-intervention	2.9 (1.2)	2.6 (1.2)
Follow-up	2.9 (1.2)	2.5 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.446
	Comments
	Method	Mixed Models Analysis
	Comments

19. Secondary Outcome

Title	Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.9 (1.4)	2.5 (1.4)
Post-intervention	3.3 (1.2)	2.9 (1.3)
Follow-up	3.3 (1.3)	3.0 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.459
	Comments
	Method	Mixed Models Analysis
	Comments

20. Secondary Outcome

Title	Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-Intervention, Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.2 (1.1)	2.2 (1.0)
Post-intervention	2.5 (1.0)	2.2 (0.9)
Follow-up	2.5 (1.1)	2.3 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments
	Method	Mixed Models Analysis
	Comments

21. Secondary Outcome

Title	Measure of Self-Management Behaviors - Accessing Social Support Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.3 (1.4)	2.3 (1.2)
Post-intervention	2.4 (1.3)	2.4 (1.3)
Follow-up	2.2 (1.3)	2.3 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.238
	Comments
	Method	Mixed Models Analysis
	Comments

22. Secondary Outcome

Title	Measure of Self-Management Behaviors - Physical Activity Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.3 (1.3)	2.3 (1.3)
Post-intervention	2.7 (1.3)	2.4 (1.3)
Follow-up	2.8 (1.3)	2.2 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Mixed Models Analysis
	Comments

23. Secondary Outcome

Title	Measure of Self-Management Behaviors - Healthy Eating Subscale
Description	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	2.6 (1.3)	2.5 (1.3)
Post-intervention	3.0 (1.1)	2.7 (1.1)
Follow-up	2.9 (1.1)	2.8 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.709
	Comments
	Method	Mixed Models Analysis
	Comments

24. Other Pre-specified Outcome

Title	Morisky Medication Adherence Scale
Description	This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months..	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	1.4 (1.0)	1.5 (0.8)
Post-intervention	1.2 (1.0)	1.5 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.134
	Comments
	Method	Mixed Models Analysis
	Comments

25. Other Pre-specified Outcome

Title	Multidimensional Health Locus of Control (HLOC)
Description	Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	26.4 (5.9)	26.1 (5.9)
Post-intervention	27.0 (4.8)	25.5 (6.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments
	Method	Mixed Models Analysis
	Comments

26. Other Pre-specified Outcome

Title	Maryland Assessment of Recovery Scale (MARS)
Description	The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.
Time Frame	Baseline, Post-intervention (3 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	3.9 (0.7)	3.8 (0.7)
Post-intervention	4.0 (0.7)	3.8 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.099
	Comments
	Method	Mixed Models Analysis
	Comments

27. Other Pre-specified Outcome

Title	Morisky Medication Adherence Scale
Description	Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
Time Frame	Baseline, Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months..	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	1.4 (1.0)	1.5 (0.8)
Post-intervention	1.2 (1.0)	1.5 (0.9)
Follow-up	1.2 (1.0)	1.4 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.852
	Comments
	Method	Mixed Models Analysis
	Comments

28. Other Pre-specified Outcome

Title	Multidimensional Health Locus of Control (HLOC)
Description	Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
Time Frame	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	26.4 (5.9)	26.1 (5.9)
Post-intervention	27.0 (4.8)	25.5 (6.3)
Follow-up	26.6 (5.4)	25.7 (5.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.285
	Comments
	Method	Mixed Models Analysis
	Comments

29. Other Pre-specified Outcome

Title	Maryland Assessment of Recovery Scale (MARS)
Description	The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)
Time Frame	Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)

Outcome Measure Data

Analysis Population Description

Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.

Arm/Group Title	Living Well	Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.	The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
Measure Participants	124	118
Baseline	3.9 (0.7)	3.8 (0.7)
Post-intervention	4.0 (0.7)	3.8 (0.7)
Follow-up	4.0 (0.7)	3.8 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Living Well, Medical Illness Education and Support Group
	Comments	The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.222
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Adverse events assessed from time of enrollment to follow-up assessment (~9 months) for each participant. Total duration of reported events during recruitment and follow-up of study assessments is about 2 years, 8 months.
Adverse Event Reporting Description	The reported All-Cause Mortality Affected and At Risk is zero as this study was deemed minimal risk and mortality due to study participation was not anticipated. In addition, there were no unanticipated deaths due to study participation.
Arm/Group Title	Living Well		Medical Illness Education and Support Group
Arm/Group Description	Living Well (LW) will be implemented as a 12-session, peer-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.		The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.
All Cause Mortality
	Living Well		Medical Illness Education and Support Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/124 (0%)		0/118 (0%)
Serious Adverse Events
	Living Well		Medical Illness Education and Support Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/124 (0%)		0/118 (0%)
Other (Not Including Serious) Adverse Events
	Living Well		Medical Illness Education and Support Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/124 (31.5%)		30/118 (25.4%)
General disorders
Hospitalization	39/124 (31.5%)	53	30/118 (25.4%)	39

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.