Clinical trial NCT01992913: Building Employment Skills Through Therapy for Veterans
Official title: Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Cognitive Behavioral Therapy
Cognition
Vocational Rehabilitation
Supported Employment
Schizoaffective Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-11-25
Enrollment: 67
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: Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive skills, social skills, and functional skills (like employment). There is a new form of cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that specifically addresses the cognitive, social, and functional deficits of schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that Veteran's receive. The investigators compared iCBT to UC in subjects with schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE) program, and evaluate whether iCBT is more helpful in improving job attainment, and other areas of functioning, both right after treatment, and 6 months after the end of treatment.

Detailed description: The objective of the current study was to evaluate whether integrated cognitive behavior therapy (iCBT) can improve engagement and success in an existing Supported Employment (SE) program among the most functionally disabled patients with schizophrenia/schizoaffective disorder. The iCBT condition also included computerized cognitive remediation. The primary specific aim was to determine whether iCBT will significantly improve work outcomes at post-treatment to a greater extent than Usual Care (UC) in low functioning patients with schizophrenia/schizoaffective disorder who join the SE program. The secondary aims were to evaluate the whether iCBT will significantly improve work outcomes at 6 month follow-up relative to UC, and whether iCBT will improve functional outcomes post-treatment and at follow-up relative to UC in subjects who join the SE program.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of DSM-IV schizophrenia or schizoaffective disorder (SCID)
* Severe/extreme functional disability \[World Health Organization Disability Assessment Scale (WHODAS) score \> 50\]
* Clinical stability (as per primary mental health provider)
* Receiving treatment at the Veterans Administration
* Minimal engagement in psychiatric rehabilitation services (just psychiatrist and therapist/case management in the last 6 months)
* Eligible for and willing to be enrolled in Supported Employment program
* Age 18 to 65
* Proficient in English
* Able to give informed consent

Exclusion Criteria:

* Neurologic disease or damage that would make the diagnosis of schizophrenia questionable
* Current opioid or stimulant dependence (SCID)
* Not appropriate due to safety concerns (based on risk assessment)

Primary outcomes:
measure: Workforce Participation Measure - Total Number of Jobs Attained
timeFrame: Baseline to post-treatment (18-months)
measure: Overall Job Attainment Proportion
timeFrame: Study start through 18 months of the active portion of the study.
measure: Job Participant Composite-hours Worked
timeFrame: Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start.
Secondary outcomes:
measure: Work Behavior Inventory
timeFrame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
measure: Specific Levels of Functioning (SLOF)
timeFrame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Steven L. Sayers, PhD
role: PRINCIPAL_INVESTIGATOR
References: