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| ID | Type | Description | Link |
|---|---|---|---|
| H-26250 | Other Identifier | University of Maryland, Baltimore IRB number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: MPROVE | Experimental | The Maryland Program for Vocational Effectiveness (MPROVE) |
|
| Arm 2: Control | Active Comparator | Supportive Treatment for SMI (control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maryland Program for Vocational Effectiveness | Behavioral | psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST) |
| Measure | Description | Time Frame |
|---|---|---|
| Employment Status | Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned. | Post Treatment (approximately 3 months after completion of the baseline assessment) |
| 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:
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. | Post Treatment |
| 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.
| Post Treatment |
| Employment Status | Data collected included from participants: weekly wages earned | Post Treatment (approximately 3 months after completion of the baseline assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Tenhula, PhD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: MPROVE | 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) |
| FG001 | Arm 2: Control | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: MPROVE | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Employment Status | Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned. | Posted | Mean | Standard Deviation | Hours worked per week | Post Treatment (approximately 3 months after completion of the baseline assessment) |
|
Duration of participants involvement in the study, which was approximately 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: MPROVE | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical Hospitalization | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Tenhula, Ph.D. | VA Central Office | 202-461-4167 | Wendy.Tenhula@va.gov |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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|
| Supportive Treatment for SMI | Other | 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. |
|
|
| Post Treatment |
| 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). | Post-Treatment |
| Arm 2: Control |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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:
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. | Posted | Mean | Standard Deviation | units on a scale | Post Treatment |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | scores on a scale | Post-Treatment |
|
|
|
| Primary | 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:
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. | Posted | Mean | Standard Deviation | rating on a scale | Post Treatment |
|
|
|
| Primary | 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.
| Posted | Mean | Standard Deviation | units on a scale | Post Treatment |
|
|
|
| Primary | Employment Status | Data collected included from participants: weekly wages earned | Posted | Mean | Standard Deviation | dollars/week | Post Treatment (approximately 3 months after completion of the baseline assessment) |
|
|
|
| 13 |
| 47 |
| 0 |
| 47 |
| EG001 | Arm 2: Control | 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. | 9 | 41 | 0 | 41 |
| Psychiatric Hospitalization | Psychiatric disorders | Non-systematic Assessment |
|
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