Cognitive Behavior Therapy and Work Outcome
Effects of CBT and Cognitive Remediation on Work in Schizophrenia
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Oct 2009
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2015
CompletedResults Posted
Study results publicly available
October 31, 2016
CompletedMay 23, 2017
April 1, 2017
5.8 years
December 16, 2008
July 22, 2016
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
6 months
Work Quantity
Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.
6 months
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.
6 months
Study Arms (3)
Arm 1
ACTIVE COMPARATORSupport group
Arm 2
EXPERIMENTALCognitive Behavior Therapy
Arm 3
EXPERIMENTALCognitive Behavior Therapy and Cognitive Remediation
Interventions
Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia spectrum disorder,
- interest in vocational rehabilitation
You may not qualify if:
- No changes in medication type or housing in the last 30 days,
- mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paul Lysaker
- Organization
- Richard L. Roudebush VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Lysaker, PhD
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 18, 2008
Study Start
October 1, 2009
Primary Completion
August 6, 2015
Study Completion
August 6, 2015
Last Updated
May 23, 2017
Results First Posted
October 31, 2016
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share