We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Behavior Therapy and Work Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00810355
First Posted: December 18, 2008
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Schizophrenia Behavioral: Support Group Behavioral: Cognitive Behavior Therapy Behavioral: Cognitive Remediation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of CBT and Cognitive Remediation on Work in Schizophrenia

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Work Quality [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.

  • Symptoms [ Time Frame: 6 months ]
    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.


Enrollment: 87
Actual Study Start Date: October 1, 2009
Study Completion Date: August 6, 2015
Primary Completion Date: August 6, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Support group
Behavioral: Support Group
General support and problem solving for work activity
Experimental: Arm 2
Cognitive Behavior Therapy
Behavioral: Support Group
General support and problem solving for work activity
Behavioral: Cognitive Behavior Therapy
Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Experimental: Arm 3
Cognitive Behavior Therapy and Cognitive Remediation
Behavioral: Support Group
General support and problem solving for work activity
Behavioral: Cognitive Behavior Therapy
Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Behavioral: Cognitive Remediation
Computerized training to enhance cognitive functioning.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810355


Locations
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Indiana University School of Medicine
Investigators
Principal Investigator: Paul Lysaker, PhD Richard L. Roudebush VA Medical Center, Indianapolis, IN
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00810355     History of Changes
Other Study ID Numbers: D6629-R
First Submitted: December 16, 2008
First Posted: December 18, 2008
Results First Submitted: July 22, 2016
Results First Posted: October 31, 2016
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Schizophrenia Spectrum Disorders
Cognitive Behavior Therapy
work

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders