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

Primary Purpose

Mental Illness, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maryland Program for Vocational Effectiveness
Supportive Treatment for SMI
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Illness focused on measuring Cognitive behavioral therapy, Social Skills training, Vocational Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: MPROVE

Arm 2: Control

Arm Description

The Maryland Program for Vocational Effectiveness (MPROVE)

Supportive Treatment for SMI (control)

Outcomes

Primary Outcome Measures

Employment Status
Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.
Work Performance (Work Behavior Inventory)
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.
Social Functioning
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
Employment Status
Data collected included from participants: weekly wages earned

Secondary Outcome Measures

Cognitive Insight
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.
Psychiatric Symptoms
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).

Full Information

First Posted
December 30, 2005
Last Updated
May 10, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00272168
Brief Title
The Use of Skills Training to Augment Compensated Work Therapy (CWT)/VI for Veterans With SMI
Acronym
MPROVE
Official Title
The Use of Skills Training to Augment CWT/VI for Veterans With SMI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Schizophrenia
Keywords
Cognitive behavioral therapy, Social Skills training, Vocational Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: MPROVE
Arm Type
Experimental
Arm Description
The Maryland Program for Vocational Effectiveness (MPROVE)
Arm Title
Arm 2: Control
Arm Type
Active Comparator
Arm Description
Supportive Treatment for SMI (control)
Intervention Type
Behavioral
Intervention Name(s)
Maryland Program for Vocational Effectiveness
Other Intervention Name(s)
M-PROVE
Intervention Description
psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)
Intervention Type
Other
Intervention Name(s)
Supportive Treatment for SMI
Other Intervention Name(s)
STS
Intervention Description
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.
Primary Outcome Measure Information:
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)
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
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
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)
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Tenhula, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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