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The Use of Skills Training to Augment CWT/VI for Veterans With SMI (MPROVE)
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, December 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00272168
  Purpose

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 Intervention
Mental Illness
Schizophrenia
Behavioral: Maryland Program for Vocational Effectiveness
Other: Supportive Treatment for SMI

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: The Use of Skills Training to Augment CWT/VI for Veterans With SMI

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Employment status, work performance, social functioning [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, cognitive insight, psychiatric symptoms [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2005
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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)
2: Active Comparator
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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272168

Contacts
Contact: Shannon Thomas-Lohrman, MS (410) 605-7000 ext 4733 shannon.thomas-lohrman@va.gov
Contact: Katrina N Spencer, MA (410) 605-7000 ext 4738 katrina.spencer@va.gov

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Shannon Thomas-Lohrman, MS     410-605-7000 ext 4733     shannon.thomas-lohrman@va.gov    
Contact: Katrina N Spencer, MA     (410) 605-7000 ext 4738     katrina.spencer@va.gov    
Principal Investigator: Wendy Tenhula, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Wendy Tenhula, PhD VA Maryland Health Care System, Baltimore
  More Information

Responsible Party: Department of Veterans Affairs ( Tenhula, Wendy - Principal Investigator )
Study ID Numbers: D3437R, H-26250
Study First Received: December 30, 2005
Last Updated: December 1, 2008
ClinicalTrials.gov Identifier: NCT00272168  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cognitive behavioral therapy
Social Skills training
Vocational Rehabilitation

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009