Clinical trial NCT00272168: The Use of Skills Training to Augment Compensated Work Therapy (CWT)/VI for Veterans With SMI
Official title: The Use of Skills Training to Augment CWT/VI for Veterans With SMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Schizophrenia
Keywords: Cognitive behavioral therapy
Social Skills training
Vocational Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-01-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Employment Status
timeFrame: Post Treatment (approximately 3 months after completion of the baseline assessment)
measure: Work Performance (Work Behavior Inventory)
timeFrame: Post Treatment
measure: Social Functioning
timeFrame: Post Treatment
measure: Employment Status
timeFrame: Post Treatment (approximately 3 months after completion of the baseline assessment)
Secondary outcomes:
measure: Cognitive Insight
timeFrame: Post Treatment
measure: Psychiatric Symptoms
timeFrame: Post-Treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Wendy Tenhula, PhD
role: PRINCIPAL_INVESTIGATOR
References: