Cognitive Behavior Therapy and Work Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00810355
First received: December 16, 2008
Last updated: October 22, 2014
Last verified: October 2014
  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 your 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Work quality and quantity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 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 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 will be paid $3.50 per hour for up to 20 hours per week. 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 We 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810355

Contacts
Contact: Nicole Beattie (317) 988-4130 nicole.beattie@va.gov
Contact: Amy Strasburger (317) 988-2162 amy.strasburger@va.gov

Locations
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis Recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Nicole Beattie    317-988-4130    nicole.beattie@va.gov   
Contact: Amy Strasburger    (317) 988-2162    amy.strasburger@va.gov   
Principal Investigator: Paul Lysaker, PhD         
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Paul Lysaker, PhD Richard L. Roudebush VA Medical Center, Indianapolis, IN
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00810355     History of Changes
Other Study ID Numbers: D6629-R
Study First Received: December 16, 2008
Last Updated: October 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Schizophrenia Spectrum Disorders
Cognitive Behavior Therapy
work

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 29, 2014