MPROVE: The Use of Skills Training to Augment Compensated Work Therapy (CWT)/VI for Veterans With SMI

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00272168
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the efficacy of a combined social skills training and cognitive-behavioral therapy intervention for seriously mentally ill Veterans as they begin employment.

Condition or Disease	Intervention/Treatment	Phase
Mental Illness; Schizophrenia	Behavioral: Maryland Program for Vocational Effectiveness; Other: Supportive Treatment for SMI	N/A

Detailed Description

In spite of the fact that most individuals with serious mental illness (SMI) express a desire to work, some 80% of these individuals in the United States are chronically unemployed or under-employed. The VA has long recognized the need for vocational rehabilitation programs to facilitate meaningful work for patents with SMI. VA vocational rehabilitation programs (Compensated Work Therapy / Veterans Industries; CWT/VI) generally follow a supported employment model which has been the most extensively studied type of program and has garnered the most empirical support for helping individuals with SMI obtain employment. Nevertheless, studies of supported employment programs find that approximately 50% of participants remain unemployed and that job retention rates among those patients who do get jobs are quite low. In fact, more than half of all clients leave their supported employment positions within 6 months. The most frequently cited reasons for job terminations among patients with SMI include interpersonal problems in the work place and difficulty coping with symptom exacerbations.

The investigators have developed a psychosocial intervention (CBT-SST) that is designed to augment CWT/VI by targeting the skills needed for reintegration into community work settings and to facilitate job retention among persons with SMI. It is a manualized intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST). The CBT module of the treatment is designed to help reduce residual symptoms of mental illness and help patients develop strategies to cope with symptom exacerbations when they occur. The SST social skills and problem solving modules are designed to help patients improve their interpersonal functioning at work.

The purpose of this study is to conduct a randomized clinical trial comparing CWT/VI augmented with CBT-SST to CWT/VI without augmentation (control condition). The investigators will recruit patients for the study as they are beginning jobs through enrollment in the CWT/VI program at the VA, as this is the critical time period for them to develop the skills needed to perform well and retain employment. Expected outcomes for CBT-SST participants relative to controls include improved job retention and earnings, improved social skills (as assessed both in the clinic and in the actual work place), better everyday problem solving skills / social function, and improvements in quality of life.

The long term objective of this research is to develop and disseminate an effective skills training program that can improve work function and job retention among persons with SMI, and thereby enhance: a) their social role functioning; and b) their quality of life.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of Skills Training to Augment CWT/VI for Veterans With SMI
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: MPROVE The Maryland Program for Vocational Effectiveness (MPROVE)	Behavioral: Maryland Program for Vocational Effectiveness; psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST); Other Names: M-PROVE
Active Comparator: Arm 2: Control Supportive Treatment for SMI (control)	Other: Supportive Treatment for SMI; Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.; Other Names: STS

Outcome Measures

Primary Outcome Measures

1. Employment Status [Post Treatment (approximately 3 months after completion of the baseline assessment)]

   Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.

2. Work Performance (Work Behavior Inventory) [Post Treatment]

   This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5: Consistently an area Needing Improvement Occasionally an area Needing Improvement Performance Adequate in this area Occasionally an area of Superior Performance Consistently an area of Superior Performance. The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study.

3. Social Functioning [Post Treatment]

   This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score. Very Poor Poor Neither good nor poor Somewhat good Very good

4. Employment Status [Post Treatment (approximately 3 months after completion of the baseline assessment)]

   Data collected included from participants: weekly wages earned

Secondary Outcome Measures

1. Cognitive Insight [Post Treatment]

   Cognitive insight was assessed using the Beck Cognitive Insight Scale, a 15-item questionnaire developed to evaluate patients' self-reflectiveness and their overconfidence in their interpretations of their experiences. Participant responses to each of these items were as follows: Do not agree at all Agree slightly Agree a lot Agree completely Total score for the self-certainty scale could range from 6 to 24. Total score for the self-reflectiveness scale could range from 9 to 36. Total score for the composite score was calculated by subtracting the summed score for the self-certainty scale from the summed score of the self-reflectiveness scale and could range from 3 to 12, lower composite scores are an indicator of lower psychiatric functioning.

2. Psychiatric Symptoms [Post-Treatment]

   Psychiatric Symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS), a widely used instrument for assessing the positive, negative, and affective symptoms of individuals who have mental illnesses. The BPRS consists of 20 symptom constructs scored from 1 (not present) to 7 (extremely severe). BPRS total score could range from 0 (not present) to 140 (extremely severe).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder, or other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder

• Enrolled in vocational rehabilitation program or working

• Age between 18 and 65 years

• Ability and willingness to attend treatment sessions for 3 months

• Judged by their treating clinician to be able to participate and provide informed consent

• Ability and willingness to provide informed consent to participate

Exclusion Criteria:

• Documented history of severe neurological disorder or head trauma with ongoing cognitive sequelae

• Inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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: Wendy Tenhula, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00272168
• Other Study ID Numbers: D3437-R; H-26250
• First Posted: Jan 4, 2006
• Last Update Posted: Jun 17, 2016
• Last Verified: May 1, 2016

• Keywords provided by VA Office of Research and Development: Cognitive behavioral therapy; Social Skills training; Vocational Rehabilitation
• Additional relevant MeSH terms: Schizophrenia; Mental Disorders

Study Results

Participant Flow

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for Serious Mental Illness (control) Supportive Treatment for Serious Mental Illness (SMI): Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Period Title: Overall Study
STARTED	47	41
COMPLETED	37	31
NOT COMPLETED	10	10

Baseline Characteristics

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control	Total
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.	Total of all reporting groups
Overall Participants	47	41	88
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.47 (6.29)	51.51 (6.07)	51.49 (6.15)
Sex: Female, Male (Count of Participants)
Female	39 83%	34 82.9%	73 83%
Male	8 17%	7 17.1%	15 17%
Region of Enrollment (participants) [Number]
United States	47 100%	41 100%	88 100%

Outcome Measures

1. Primary Outcome

Title	Employment Status
Description	Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.
Time Frame	Post Treatment (approximately 3 months after completion of the baseline assessment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Measure Participants	37	31
Mean (Standard Deviation) [Hours worked per week]	26.2 (12.39)	24.83 (9.43)

2. Secondary Outcome

Title	Cognitive Insight
Description	Cognitive insight was assessed using the Beck Cognitive Insight Scale, a 15-item questionnaire developed to evaluate patients' self-reflectiveness and their overconfidence in their interpretations of their experiences. Participant responses to each of these items were as follows: Do not agree at all Agree slightly Agree a lot Agree completely Total score for the self-certainty scale could range from 6 to 24. Total score for the self-reflectiveness scale could range from 9 to 36. Total score for the composite score was calculated by subtracting the summed score for the self-certainty scale from the summed score of the self-reflectiveness scale and could range from 3 to 12, lower composite scores are an indicator of lower psychiatric functioning.
Time Frame	Post Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Measure Participants	37	31
Mean (Standard Deviation) [units on a scale]	9.56 (5.32)	7.29 (5.79)

3. Secondary Outcome

Title	Psychiatric Symptoms
Description	Psychiatric Symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS), a widely used instrument for assessing the positive, negative, and affective symptoms of individuals who have mental illnesses. The BPRS consists of 20 symptom constructs scored from 1 (not present) to 7 (extremely severe). BPRS total score could range from 0 (not present) to 140 (extremely severe).
Time Frame	Post-Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Measure Participants	47	41
Mean (Standard Deviation) [scores on a scale]	36.25 (8.69)	38.71 (10.63)

4. Primary Outcome

Title	Work Performance (Work Behavior Inventory)
Description	This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5: Consistently an area Needing Improvement Occasionally an area Needing Improvement Performance Adequate in this area Occasionally an area of Superior Performance Consistently an area of Superior Performance. The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study.
Time Frame	Post Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Measure Participants	37	31
Mean (Standard Deviation) [rating on a scale]	2.37 (0.76)	2.37 (0.74)

5. Primary Outcome

Title	Social Functioning
Description	This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score. Very Poor Poor Neither good nor poor Somewhat good Very good
Time Frame	Post Treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Measure Participants	37	31
Mean (Standard Deviation) [units on a scale]	3.69 (1.2)	3.56 (1.31)

6. Primary Outcome

Title	Employment Status
Description	Data collected included from participants: weekly wages earned
Time Frame	Post Treatment (approximately 3 months after completion of the baseline assessment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: MPROVE	Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)	Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
Measure Participants	37	31
Mean (Standard Deviation) [dollars/week]	143.08 (186.76)	72.07 (79.81)

Adverse Events

Time Frame	Duration of participants involvement in the study, which was approximately 12 months.
Arm/Group Title	Arm 1: MPROVE		Arm 2: Control
Arm/Group Description	The Maryland Program for Vocational Effectiveness (MPROVE) Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)		Supportive Treatment for SMI (control) Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.
All Cause Mortality
	Arm 1: MPROVE		Arm 2: Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: MPROVE		Arm 2: Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/47 (27.7%)		9/41 (22%)
General disorders
Medical Hospitalization	7/47 (14.9%)		2/41 (4.9%)
Psychiatric disorders
Psychiatric Hospitalization	6/47 (12.8%)		7/41 (17.1%)
Other (Not Including Serious) Adverse Events
	Arm 1: MPROVE		Arm 2: Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/41 (0%)

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.