Cognitive Behavior Therapy and Work Outcome
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Support Group
Cognitive Behavior Therapy
Cognitive Remediation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia Spectrum Disorders, Cognitive Behavior Therapy, work
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizophrenia spectrum disorder,
- interest in vocational rehabilitation
Exclusion Criteria:
- No changes in medication type or housing in the last 30 days,
- mental retardation
Sites / Locations
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Support group
Cognitive Behavior Therapy
Cognitive Behavior Therapy and Cognitive Remediation
Outcomes
Primary Outcome Measures
Work Quality
Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance.
Work Quantity
Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.
Symptoms
Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT00810355
First Posted
December 16, 2008
Last Updated
April 12, 2017
Sponsor
VA Office of Research and Development
Collaborators
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00810355
Brief Title
Cognitive Behavior Therapy and Work Outcome
Official Title
Effects of CBT and Cognitive Remediation on Work in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
August 6, 2015 (Actual)
Study Completion Date
August 6, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Indiana University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research studies the effects of Cognitive Behavior Therapy and Cognitive Remediation on work for persons with schizophrenia. Cognitive Behavior Therapy is a form of counseling that helps people to improve their mental health by changing the way they think about themselves and others. Cognitive Remediation is an exercise to improve the thinking process. The purpose of this study is to determine the extent to which Cognitive Remediation combined with Cognitive Behavior Therapy helps people who are working.
Detailed Description
Objectives: The proposed grant seeks to compare the effects of a manualized form of Cognitive Behavior Therapy (CBT) combined with Cognitive Remediation (CR) with CBT alone and Support Services (SS) alone on vocational outcomes for persons with schizophrenia spectrum disorders. Key hypotheses are: I) Participants receiving CBT +CR will work more weeks and hours than participants receiving CBT alone or SS alone; II) Participants receiving CBT + CR condition will show better work performance than the CBT alone and SS alone conditions; III) Participants receiving CBT + CR will experience greater improvements in symptoms, dysfunctional beliefs and quality of life than the CBT alone or SS alone conditions Research Plan: One hundred twenty participants with Structured Clinical Interview for DSM-IV (SCID) confirmed diagnoses of schizophrenia or schizoaffective disorder will be recruited from the Roudebush VA Medical Center , surrounding mental health centers and the Marion VA Medical Center. Participants with these diagnoses will be eligible if they are sufficiently stable to sustain participant in rehabilitation, as defined by no hospitalizations, medication or housing changes in the last 30 days. Participants will be offered a 6 month paid job placement and randomly assigned to receive either CBT + CR, CBT only or SS only.
Methodology: Following informed consent, a baseline assessment will include an inventory of work, residential, substance abuse, legal, quality of life, psychiatric and service utilization history. Participants will be offered a 26-week job placement at the VA Medical center or within the community and randomly assigned to receive 6 months of either CBT +CR, CBT only or SS. Jobs will include entry-level positions supervised by regular job site supervisors. Participants in the SS condition will attend a weekly individual and support group offering unstructured support regarding work related problems they identify. Participants in the CBT group will attend weekly group and individual sessions employing a manualized CBT intervention to identify and correct dysfunctional cognitions related to work. Participants in the CBT + CR condition will attend meetings as indicated for CBT along with performing cognitive exercises on the computer, progressing at their own pace. Hours of work will be recorded weekly. Work performance will be measured biweekly. Symptoms and cognitions will be assessed every 2 months. Primary forms of data analyses will be multivariate repeated measure analyses of variance in which CBT +CR, CBT only and SS groups will be compared on vocational, symptom, and self-esteem variables.
Results: The investigators have recently demonstrated in separate randomized controlled trials that CBT and CR can be fully implemented in a VA setting and that each leads to better work outcomes in schizophrenia. Means and standard deviations of key outcomes have been determined and are used in the power analysis for this study.
Significance: The proposed research aims provide a scientifically sound exploration of the therapeutic value of productive activity in the rehabilitation of persons with schizophrenia and to determine the extent to which manualized CBT procedures when combined with CR may contribute to the success of this process. Results may provide exportable guidelines for augmenting work services with an appropriate psychological treatment. This information may lead to more effective rehabilitation programs as well as increases in productivity, functional independence and an enhanced quality of life for persons with schizophrenia. The study also fulfills the rehabilitation goal of maximum inclusion by providing CBT and CR services that may make it possible for some patients to function at work that otherwise could not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia Spectrum Disorders, Cognitive Behavior Therapy, work
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Support group
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy and Cognitive Remediation
Intervention Type
Behavioral
Intervention Name(s)
Support Group
Intervention Description
General support and problem solving for work activity
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Description
Computerized training to enhance cognitive functioning.
Primary Outcome Measure Information:
Title
Work Quality
Description
Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance.
Time Frame
6 months
Title
Work Quantity
Description
Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.
Time Frame
6 months
Title
Symptoms
Description
Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizophrenia spectrum disorder,
interest in vocational rehabilitation
Exclusion Criteria:
No changes in medication type or housing in the last 30 days,
mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Lysaker, PhD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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