Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02391363
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 247
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: Cognitive behavior treatment; Behavioral: Information and referral	N/A

Detailed Description

Background: Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied. This significant worry can negatively affect thinking, and it is associated with poorer sleep, more depression, and worse general health. Despite its prevalence, researchers have not studied significant worry enough, particularly in low-income racial and ethnic minority populations. We know these groups are unlikely to have adequate mental health care. We also know that older adults and minorities prefer treatments for worry that do not require medication, and that these kinds of treatments can be effective. Additional tests of treatments that do not involve drugs are needed in low-income racial and ethnic minority populations. Such person-centered research could expand access to appropriate care.

Objectives: The study team plans to compare two approaches, one called Calmer Life (CL) and another called Enhanced Community Care (ECC). CL helps individuals by providing worry-reduction skills and resource counseling for basic needs in a flexible, culturally supportive manner. ECC relies on standard information and resource counseling. The study will answer three questions. First, compared to ECC, is CL more effective at relieving significant worry? Second, which one is more effective at reducing anxiety and depression and improving sleep, ability to do daily activities, and use of medical services? Third, are improvements still present three months after treatment concludes?

Methods: In agreement with our community partners and governed by a council of community leaders, consumers, and providers from low-income minority communities, we will conduct the study. This community-academic partnership, created four years ago, introduced CL to the community. Case managers and community health workers from partner organizations were trained to implement CL. They taught worry-reduction skills and helped participants increase their use of community resources. Content was flexible so that participants could choose which skills to learn and whether or not to include religion or spirituality. They also could learn skills at home, by telephone, or in the community. In a new, larger comparison study, we will enroll 120 women and 30 men who are 50 years of age or older with significant worry. Most (80 percent) will be African American, and 70 percent will have income below poverty. Participants will be assigned by chance to CL or ECC and treated for six months. Brief assessments at enrollment and at six and nine months will rely on participants' reports. Differences will be measured statistically.

Study Design

• Study Type: Interventional
• Actual Enrollment: 247 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calmer Life Cognitive behavior treatment for anxiety	Behavioral: Cognitive behavior treatment; Anxiety management skills with the option to included religious/spiritual beliefs and practices
Active Comparator: Enhanced Community Care Enhanced information and referral services for mental health and basic needs	Behavioral: Information and referral; Resource counseling and follow-up for mental health and basic needs

Outcome Measures

Primary Outcome Measures

1. Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months [Baseline, 6 months]

   Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.

2. Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months [Baseline, 9 months]

   Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.

3. Generalized Anxiety Disorder-7 (GAD-7) at 6 Months [Baseline, 6 months]

   Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.

4. Generalized Anxiety Disorder-7 (GAD-7) at 9 Months [Baseline, 9 months]

   Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.

Secondary Outcome Measures

1. Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months [Baseline, 6 months]

   Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.

2. Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months [Baseline, 9 months]

   Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.

3. Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months [Baseline, 6 months]

   Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.

4. Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months [Baseline, 9 months]

   Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.

5. Geriatric Depression Scale Short Form (GDS) at 6 Months [Baseline, 6 months]

   Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.

6. Geriatric Depression Scale Short Form (GDS) at 9 Months [Baseline, 9 months]

   Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.

7. Insomnia Severity Index (ISI) at 6 Months [Baseline, 6 months]

   Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.

8. Insomnia Severity Index (ISI) at 9 Months [Baseline, 9 months]

   Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.

9. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months [Baseline, 6 months]

   Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.

10. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months [Baseline, 9 months]

    Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.

11. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months [Baseline, 6 months]

    Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.

12. Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation [Baseline, 9 months]

    Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.

13. Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months [Baseline, 6 months]

    Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.

14. Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) [Baseline, 9 months]

    Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.

15. Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months [Baseline, 6 months]

    Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.

16. Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months [Baseline, 9 months]

    Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.

17. PTSD Checklist-5 (PCL-5) Total at 6 Months [Baseline, 6 months]

    Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.

18. PTSD Checklist-5 (PCL-5) Total at 9 Months [Baseline, 9 months]

    Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.

19. Health Service Use at 6 Months [Baseline, 6 months]

    Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.

20. Health Service Use at 9 Months [Baseline, 9 months]

    Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.

21. Hospital Admissions at 6 Months [Baseline, 6 months]

    Number of participants who were admitted to a hospital in the past 3 months.

22. Hospital Admissions at 9 Months [Baseline, 9 months]

    Number of participants who were admitted to a hospital in the past 3 months.

23. Social Service or Resource Use at 6 Months [Baseline, 6 months]

    Number of participants who received social services or resources over the past 3 months

24. Social Service or Resource Use at 9 Months [Baseline, 9 months]

    Number of participants who received social services or resources over the past 3 months

25. Psychological Service Use at 6 Months [Baseline, 6 months]

    Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months

26. Psychological Service Use at 9 Months [Baseline, 9 months]

    Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• PSWQ greater than 22

Exclusion Criteria:

• PHQ score less than 20

• Active suicidal intent

• Active psychosis or bipolar disorder

• Substance abuse

• Cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt)	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Melinda A Stanley, PhD, Baylor College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2018

More Information

Publications

None provided.

• Responsible Party: Melinda Stanley, Professor and Head, Division of Psychology, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02391363
• Other Study ID Numbers: AD-1310-06824
• First Posted: Mar 18, 2015
• Last Update Posted: May 31, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Melinda Stanley, Professor and Head, Division of Psychology, Baylor College of Medicine: anxiety; worry

Study Results

Participant Flow

Recruitment Details	Recruitment occurred from February 2015 through October 2016 in community settings where older adults gather and/or receive services such as social service agencies, churches, senior housing and community centers.
Pre-assignment Detail	Prior to random assignment, participants were screened at three separate times. During this process, 84 participants were ineligible due to presence of exclusionary criteria, 24 were lost to follow-up and 5 withdrew from the study.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Period Title: Overall Study
STARTED	70	64
COMPLETED	59	56
NOT COMPLETED	11	8

Baseline Characteristics

Arm/Group Title	Calmer Life	Enhanced Community Care	Total
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs	Total of all reporting groups
Overall Participants	70	64	134
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.69 (9.394)	67.14 (9.127)	66.90 (9.235)
Sex: Female, Male (Count of Participants)
Female	61 87.1%	48 75%	109 81.3%
Male	9 12.9%	16 25%	25 18.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 4.3%	3 4.7%	6 4.5%
Not Hispanic or Latino	67 95.7%	61 95.3%	128 95.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
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	1 1.4%	0 0%	1 0.7%
Black or African American	49 70%	54 84.4%	103 76.9%
White	18 25.7%	10 15.6%	28 20.9%
More than one race	1 1.4%	0 0%	1 0.7%
Unknown or Not Reported	1 1.4%	0 0%	1 0.7%
Region of Enrollment (Count of Participants)
United States	70 100%	64 100%	134 100%
Years of Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.91 (2.853)	13.28 (2.740)	13.61 (2.807)
Marital Status (Count of Participants)
Married	18 25.7%	15 23.4%	33 24.6%
Never Married	7 10%	11 17.2%	18 13.4%
Separated	3 4.3%	2 3.1%	5 3.7%
Divorced	29 41.4%	20 31.3%	49 36.6%
Widowed	13 18.6%	16 25%	29 21.6%
Income (Count of Participants)
<$10,000	13 18.6%	23 35.9%	36 26.9%
$10,000 - $20,000	29 41.4%	24 37.5%	53 39.6%
$20,000 - $30,000	11 15.7%	8 12.5%	19 14.2%
$30,000 - $40,000	8 11.4%	4 6.3%	12 9%
$40,000 - $50,000	3 4.3%	3 4.7%	6 4.5%
$50,000 - $60,000	5 7.1%	1 1.6%	6 4.5%
≥$60,000	1 1.4%	1 1.6%	2 1.5%
Psychotropic Medication Use (Count of Participants)
Any psychotropic	21 30%	18 28.1%	39 29.1%
Anti-anxiety	7 10%	7 10.9%	14 10.4%
Anti-depressant	16 22.9%	13 20.3%	29 21.6%
Anti-psychotic	4 5.7%	1 1.6%	5 3.7%
Hypnotic/Sleep	7 10%	7 10.9%	14 10.4%
Medication Use, Total (number of medications) [Mean (Standard Deviation) ]
Psychotropic	0.50 (0.897)	0.44 (0.778)	0.47 (0.840)
Non-psychotropic	4.64 (3.323)	4.51 (3.671)	4.58 (3.480)
Diagnoses (Count of Participants)
None recorded	5 7.1%	4 6.3%	9 6.7%
Generalized Anxiety Disorder (GAD)	57 81.4%	45 70.3%	102 76.1%
Any Depressive Disorder	35 50%	34 53.1%	69 51.5%
Post Traumatic Stress Dissorder (PTSD)	5 7.1%	3 4.7%	8 6%
Social Phobia	13 18.6%	19 29.7%	32 23.9%
Specific Phobia	26 37.1%	33 51.6%	59 44%
Other Specificied Anxiety Disorder (OSAD) (GAD)	4 5.7%	10 15.6%	14 10.4%
OSAD (Other)	3 4.3%	3 4.7%	6 4.5%
Panic	4 5.7%	2 3.1%	6 4.5%
Service Use (Count of Participants)
Health Services	64 91.4%	56 87.5%	120 89.6%
Hospital Admissions	12 17.1%	10 15.6%	22 16.4%
Social Services	22 31.4%	17 26.6%	39 29.1%
Psychological Services	42 60%	29 45.3%	71 53%
Expectancy Rating Scale (ERS) Cred (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26.34 (4.213)	25.03 (5.688)	25.72 (4.991)
Expectancy Rating Scale (ERS) Exp (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.58 (1.762)	7.69 (2.650)	8.16 (2.264)
Penn State Worry Questionnaire-A (PSWQ-A) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26.73 (7.535)	26.25 (6.933)	26.50 (7.231)
Generalized Anxiety Disorder-7 (GAD-7) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.00 (5.421)	10.56 (5.108)	10.79 (5.259)
Geriatric Anxiety Inventory-SF (GAI-SF) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.39 (1.544)	3.30 (1.752)	3.34 (1.641)
Geriatric Depression Scale Short Form (GDS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.97 (3.547)	5.61 (3.697)	5.80 (3.610)
Insomnia Severity Index (ISI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.44 (6.841)	13.00 (6.264)	13.23 (6.551)
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	48.90 (6.281)	48.05 (7.231)	48.49 (6.739)
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	59.05 (10.799)	59.38 (10.429)	59.21 (10.585)
PTSD Checklist-5 (PCL-5) Total (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	28.77 (16.601)	26.92 (16.157)	27.89 (16.355)
Patient Health Questionnaire depression scale (PHQ 8) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.41 (6.076)	11.13 (5.849)	11.28 (5.948)
Brief RCOPE Positive Subscale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	24.22 (4.702)	23.84 (4.144)	24.04 (4.424)
Brief RCOPE Negative subscale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	10.38 (4.815)	10.96 (5.044)	10.66 (4.915)
Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	38.38 (12.468)	38.51 (11.498)	38.44 (11.969)
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	40.08 (9.708)	40.14 (10.150)	40.11 (9.884)

Outcome Measures

1. Primary Outcome

Title	Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months
Description	Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	26.73 (7.53)	26.25 (6.93)
6 months	22.04 (8.54)	23.04 (7.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.08 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

2. Primary Outcome

Title	Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months
Description	Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	26.73 (7.53)	26.25 (6.93)
9 months	21.87 (8.72)	20.18 (7.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 3.50 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

3. Primary Outcome

Title	Generalized Anxiety Disorder-7 (GAD-7) at 6 Months
Description	Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	11.00 (5.42)	10.56 (5.11)
6 months	7.13 (6.41)	8.11 (5.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.92. (Numerator df = 1, Denominator df varies, as multiple imputation was used).

4. Primary Outcome

Title	Generalized Anxiety Disorder-7 (GAD-7) at 9 Months
Description	Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	11.00 (5.42)	10.56 (5.11)
9 months	7.54 (5.51)	6.62 (5.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 3.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

5. Secondary Outcome

Title	Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months
Description	Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	3.39 (1.54)	3.30 (1.75)
6 months	2.25 (2.00)	2.48 (1.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.59 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

6. Secondary Outcome

Title	Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months
Description	Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	3.39 (1.54)	3.30 (1.75)
9 months	2.65 (2.11)	2.31 (1.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 2.37 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

7. Secondary Outcome

Title	Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months
Description	Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	11.41 (6.08)	11.13 (5.85)
6 months	7.28 (6.48)	8.48 (6.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

8. Secondary Outcome

Title	Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months
Description	Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	11.41 (6.08)	11.13 (5.85)
9 months	7.39 (6.35)	7.00 (5.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 1.14 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

9. Secondary Outcome

Title	Geriatric Depression Scale Short Form (GDS) at 6 Months
Description	Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	5.97 (3.55)	5.61 (3.70)
6 months	3.75 (3.42)	4.33 (3.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 2.19 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

10. Secondary Outcome

Title	Geriatric Depression Scale Short Form (GDS) at 9 Months
Description	Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	5.97 (3.55)	5.61 (3.70)
9 months	3.80 (3.49)	3.92 (3.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.30 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

11. Secondary Outcome

Title	Insomnia Severity Index (ISI) at 6 Months
Description	Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	13.44 (6.84)	13.00 (6.26)
6 months	10.08 (8.08)	10.13 (7.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.22 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

12. Secondary Outcome

Title	Insomnia Severity Index (ISI) at 9 Months
Description	Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	13.44 (6.84)	13.00 (6.26)
9 months	9.81 (7.65)	9.51 (6.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.88 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

13. Secondary Outcome

Title	Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months
Description	Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	48.90 (6.28)	48.05 (7.23)
6 months	51.05 (7.30)	49.83 (6.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

14. Secondary Outcome

Title	Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months
Description	Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	48.90 (6.28)	48.05 (7.23)
9 months	50.85 (8.05)	49.64 (8.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = .01(Numerator df = 1, Denominator df varies, as multiple imputation was used).

15. Secondary Outcome

Title	Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months
Description	Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	59.05 (10.80)	59.39 (10.43)
6 months	64.54 (16.97)	62.64 (13.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.29 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

16. Secondary Outcome

Title	Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
Description	Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	59.05 (10.80)	59.39 (10.43)
9 months	62.30 (13.86)	62.45 (13.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

17. Secondary Outcome

Title	Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months
Description	Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	38.38 (12.47)	38.51 (11.50)
6 months	37.86 (12.09)	36.45 (11.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F= 0.23 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

18. Secondary Outcome

Title	Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)
Description	Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	38.38 (12.47)	38.51 (11.50)
9 months	38.37 (13.26)	36.93 (12.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

19. Secondary Outcome

Title	Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months
Description	Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	40.08 (9.71)	40.14 (10.15)
6 months	47.25 (12.17)	45.91 (10.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.98
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

20. Secondary Outcome

Title	Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months
Description	Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	40.08 (9.71)	40.14 (10.15)
9 months	46.98 (10.46)	47.27 (11.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F= 0.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

21. Secondary Outcome

Title	PTSD Checklist-5 (PCL-5) Total at 6 Months
Description	Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	28.77 (16.60)	18.02 (18.85)
6 months	26.92 (16.16)	20.35 (16.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 1.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

22. Secondary Outcome

Title	PTSD Checklist-5 (PCL-5) Total at 9 Months
Description	Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	28.77 (16.60)	26.92 (16.16)
9 months	18.28 (17.39)	18.53 (15.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments	P-value for treatment-group effect (CL vs ECC)
	Method	ANCOVA
	Comments	Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).

23. Secondary Outcome

Title	Health Service Use at 6 Months
Description	Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	64 91.4%	56 87.5%
6 months	47 67.1%	45 70.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments
	Type of Statistical Test	Superiority
	Comments	We expected to reject the null hypothesis of no treatment group difference in 6 month health service use, controlling for baseline health service use. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
Statistical Test of Hypothesis	p-Value	0.52
	Comments	Parameter estimate for treatment group = 0.40 (SE = 0.63). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

24. Secondary Outcome

Title	Health Service Use at 9 Months
Description	Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	64 91.4%	56 87.5%
9 months	52 74.3%	39 60.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	Parameter estimate for treatment group = 1.79 (SE = 0.85). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

25. Secondary Outcome

Title	Hospital Admissions at 6 Months
Description	Number of participants who were admitted to a hospital in the past 3 months.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	12 17.1%	10 15.6%
6 months	12 17.1%	5 7.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	Parameter estimate for treatment group = 1.56 (SE = 0.74). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

26. Secondary Outcome

Title	Hospital Admissions at 9 Months
Description	Number of participants who were admitted to a hospital in the past 3 months.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	12 17.1%	10 15.6%
9 months	14 20%	3 4.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	Parameter estimate for treatment group = 2.96 (SE = 0.91). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

27. Secondary Outcome

Title	Social Service or Resource Use at 6 Months
Description	Number of participants who received social services or resources over the past 3 months
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	22 31.4%	17 26.6%
6 months	17 24.3%	11 17.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments	Parameter estimate for treatment group = 0.42 (SE = 0.51). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

28. Secondary Outcome

Title	Social Service or Resource Use at 9 Months
Description	Number of participants who received social services or resources over the past 3 months
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	22 31.4%	17 26.6%
9 months	18 25.7%	14 21.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments	Parameter estimate for treatment group = 0.09 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

29. Secondary Outcome

Title	Psychological Service Use at 6 Months
Description	Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	42 60%	29 45.3%
6 months	31 44.3%	31 48.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments	Parameter estimate for treatment group = -0.28 (SE = 0.46). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

30. Secondary Outcome

Title	Psychological Service Use at 9 Months
Description	Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

134 participants who completed baseline assessment.

Arm/Group Title	Calmer Life	Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices	Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
Measure Participants	70	64
Baseline	42 60%	29 45.3%
9 months	26 37.1%	20 31.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calmer Life, Enhanced Community Care
	Comments	We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use. Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates. A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments	Parameter estimate for treatment group = -0.29 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity
	Method	Regression, Logistic
	Comments	ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.

Adverse Events

Time Frame	2.5 years
Adverse Event Reporting Description	No adverse events were reported.
Arm/Group Title	Calmer Life		Enhanced Community Care
Arm/Group Description	Cognitive behavior treatment for anxiety Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices		Enhanced information and referral services for mental health and basic needs Information and referral: Resource counseling and follow-up for mental health and basic needs
All Cause Mortality
	Calmer Life		Enhanced Community Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/64 (0%)
Serious Adverse Events
	Calmer Life		Enhanced Community Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/64 (0%)
Other (Not Including Serious) Adverse Events
	Calmer Life		Enhanced Community Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/64 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.