The Use of Skills Training to Augment CWT/VI for Veterans With SMI

Schizophrenia Clinical Trial

— MPROVE  

Official title:

The Use of Skills Training to Augment CWT/VI for Veterans With SMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272168
• Other study ID #: D3437-R
• Secondary ID: H-26250
• Status: Completed
• Phase: N/A
• First received: December 30, 2005
• Last updated: April 27, 2015
• Start date: October 2005
• Est. completion date: October 2009

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

We 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). We 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Schizophrenia

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Employment status, work performance, social functioning		6 months post-treatment	No
Secondary	Quality of life, cognitive insight, psychiatric symptoms		6 months post-treatment	No