Cognitive Remediation and Functional Skills Training in Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Remediation
FAST
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Psychosis, Schizoaffective Disorder
Eligibility Criteria
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
Sites / Locations
- Queen's University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Cognitive remediation
Functional Adaptive Skills Training
Combined Treatment
Arm Description
Cognitive remediation
Functional and social skills group treatment
Combined cognitive remediation and functional adaptive skills training
Outcomes
Primary Outcome Measures
neurocognition
Secondary Outcome Measures
functional competence
performance-based measures of functional and social competence
neurocognition
neurocognition
functional competence
functional competence
Full Information
NCT ID
NCT01175642
First Posted
August 3, 2010
Last Updated
November 16, 2016
Sponsor
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT01175642
Brief Title
Cognitive Remediation and Functional Skills Training in Schizophrenia
Official Title
Specificity and Generalizability of Cognitive Remediation and Functional Skills Training in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Alliance for Research on Schizophrenia and Depression
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Psychosis, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive remediation
Arm Type
Experimental
Arm Description
Cognitive remediation
Arm Title
Functional Adaptive Skills Training
Arm Type
Active Comparator
Arm Description
Functional and social skills group treatment
Arm Title
Combined Treatment
Arm Type
Active Comparator
Arm Description
Combined cognitive remediation and functional adaptive skills training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Description
Computer-based, therapist-lead cognitive remediation
Intervention Type
Behavioral
Intervention Name(s)
FAST
Intervention Description
Functional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills
Primary Outcome Measure Information:
Title
neurocognition
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
functional competence
Description
performance-based measures of functional and social competence
Time Frame
12 weeks
Title
neurocognition
Time Frame
24 weeks
Title
neurocognition
Time Frame
36 weeks
Title
functional competence
Time Frame
24 weeks
Title
functional competence
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Bowie, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22581070
Citation
Bowie CR, McGurk SR, Mausbach B, Patterson TL, Harvey PD. Combined cognitive remediation and functional skills training for schizophrenia: effects on cognition, functional competence, and real-world behavior. Am J Psychiatry. 2012 Jul;169(7):710-8. doi: 10.1176/appi.ajp.2012.11091337.
Results Reference
derived
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Cognitive Remediation and Functional Skills Training in Schizophrenia
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