Cognitive Training for Patients With Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Other Primary Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis NOS)
- Age 18 or older
- Fluency in English
Exclusion Criteria:
- Dementia
- Neurological conditions affecting cognition
- Mental retardation
- Substance use disorder within the past month
- Participation in other intervention trials
Sites / Locations
- UCSD Outpatient Psychiatric Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive Training
Standard Pharmacotherapy
Arm Description
Cognitive training group
Outcomes
Primary Outcome Measures
UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)
Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.
Secondary Outcome Measures
Hopkins Verbal Learning Test Percent Retained
Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial.
Score ranges from 0-100. Higher scores represent better performance.
Full Information
NCT ID
NCT01521026
First Posted
January 22, 2012
Last Updated
June 30, 2023
Sponsor
University of California, San Diego
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT01521026
Brief Title
Cognitive Training for Patients With Schizophrenia
Official Title
Cognitive Training for Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research on cognitive training addresses the following questions:
Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses?
What are the neurocognitive and non-cognitive factors that predict good outcomes following cognitive rehabilitation? In addition to verbal learning and memory, immediate verbal memory, vigilance, and executive functioning, the cognitive training intervention attempted to improve prospective memory ability (i.e., the ability to remember to do things in the future, such as take medications or attend a doctor's appointment).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Other Primary Psychotic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Cognitive training group
Arm Title
Standard Pharmacotherapy
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
12-week compensatory cognitive training in group format
Primary Outcome Measure Information:
Title
UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)
Description
Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hopkins Verbal Learning Test Percent Retained
Description
Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial.
Score ranges from 0-100. Higher scores represent better performance.
Time Frame
3 months
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:
Primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis NOS)
Age 18 or older
Fluency in English
Exclusion Criteria:
Dementia
Neurological conditions affecting cognition
Mental retardation
Substance use disorder within the past month
Participation in other intervention trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth W Twamley, PhD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Outpatient Psychiatric Services
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22939029
Citation
Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste DV. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1212-9. doi: 10.4088/JCP.12m07686. Epub 2012 Aug 7.
Results Reference
derived
Learn more about this trial
Cognitive Training for Patients With Schizophrenia
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