Mental IllnessMPROVENCT00272168
The Use of Skills Training to Augment Compensated Work Therapy (CWT)/VI for Veterans With SMI
A study testing Maryland Program for Vocational Effectiveness and Supportive Treatment for SMI in people with Mental Illness and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Illness, Schizophrenia
- What is being tested?
- Maryland Program for Vocational Effectiveness and Supportive Treatment for SMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: The Use of Skills Training to Augment CWT/VI for Veterans With SMI
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.
Read the 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.
- Conditions
- Mental Illness, Schizophrenia
- Being tested
- Maryland Program for Vocational Effectiveness, Supportive Treatment for SMI
- Keywords
- Cognitive behavioral therapy, Social Skills training, Vocational Rehabilitation
- Medical subject headings
- Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maryland Program for Vocational EffectivenessBehavioural
Also called M-PROVE
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 SMIOther
Also called STS
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: MPROVE | Experimental | The Maryland Program for Vocational Effectiveness (MPROVE) Receives: Behavioral: Maryland Program for Vocational Effectiveness |
| Arm 2: Control | Active comparator | Supportive Treatment for SMI (control) Receives: Other: Supportive Treatment for SMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment Status
Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.
Measured: 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:
- 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.
Measured: 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.
- Very Poor
- Poor
- Neither good nor poor
- Somewhat good
- Very good
Measured: Post Treatment
Employment Status
Data collected included from participants: weekly wages earned
Measured: Post Treatment (approximately 3 months after completion of the baseline assessment)
Secondary outcomes (2)
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.
Measured: 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).
Measured: Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Wendy Tenhula, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272168
- Sponsor's protocol ID
- D3437-R
- Other IDs
- H-26250
- Acronym
- MPROVE
- Status last verified
- May 2016
- First submitted
- 30 Dec 2005
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Skills Training to Augment CWT/VI for Veterans With SMI
- ClinicalTrials.gov ID
- NCT00272168
- Acronym / sponsor ID
- MPROVE / D3437-R
- Conditions
- Mental Illness, Schizophrenia
- Keywords
- Cognitive behavioral therapy, Social Skills training, Vocational Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Jan 2006 (estimated)
- Results
- Posted 17 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MPROVE | Experimental | Behavioral: Maryland Program for Vocational EffectivenessThe Maryland Program for Vocational Effectiveness (MPROVE) |
| Arm 2: Control | Active comparator | Other: Supportive Treatment for SMISupportive Treatment for SMI (control) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maryland Program for Vocational EffectivenessAlso: M-PROVEpsychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST) | Behavioural | Arm 1: MPROVE |
| Supportive Treatment for SMIAlso: STSSessions 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 | Arm 2: Control |
Primary outcome
Employment Status
Time frame: 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.
Work Performance (Work Behavior Inventory)
Time frame: 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: 1. Consistently an area Needing Improvement 2. Occasionally an area Needing Improvement 3. Performance Adequate in this area 4. Occasionally an area of Superior Performance 5. 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
Time frame: 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. 1. Very Poor 2. Poor 3. Neither good nor poor 4. Somewhat good 5. Very good
Employment Status
Time frame: Post Treatment (approximately 3 months after completion of the baseline assessment)
Data collected included from participants: weekly wages earned
2 secondary outcomes
Cognitive Insight
Time frame: Post Treatment
Psychiatric Symptoms
Time frame: Post-Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Tenhula, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maryland Program for Vocational Effectiveness and Supportive Treatment for SMI in people with Mental Illness and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment Status (time frame: Post Treatment (approximately 3 months after completion of the baseline assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.