- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01175642
Cognitive Remediation and Functional Skills Training in Schizophrenia
November 16, 2016 updated by: Christopher R. Bowie, National Alliance for Research on Schizophrenia and Depression
Specificity and Generalizability of Cognitive Remediation and Functional Skills Training in Schizophrenia
This randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- Queen's University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of schizophrenia or schizoaffective disorder
- Enrolled in outpatient mental health care
- Reading level of 6th grade or higher
- English speaking
Exclusion Criteria:
- Medical conditions known to affect cognition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive remediation
|
Computer-based, therapist-lead cognitive remediation
|
|
Active Comparator: Functional Adaptive Skills Training
Functional and social skills group treatment
|
Functional adaptive skills training.
Group treatment to foster the acquisition of social and adaptive skills
|
|
Active Comparator: Combined Treatment
Combined cognitive remediation and functional adaptive skills training
|
Computer-based, therapist-lead cognitive remediation
Functional adaptive skills training.
Group treatment to foster the acquisition of social and adaptive skills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
neurocognition
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional competence
Time Frame: 12 weeks
|
performance-based measures of functional and social competence
|
12 weeks
|
|
neurocognition
Time Frame: 24 weeks
|
24 weeks
|
|
|
neurocognition
Time Frame: 36 weeks
|
36 weeks
|
|
|
functional competence
Time Frame: 24 weeks
|
24 weeks
|
|
|
functional competence
Time Frame: 36 weeks
|
36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christopher R Bowie, PhD, Queen's University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
August 3, 2010
First Submitted That Met QC Criteria
August 4, 2010
First Posted (Estimate)
August 5, 2010
Study Record Updates
Last Update Posted (Estimate)
November 17, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYC-085-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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