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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
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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

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Cognitive Training for Patients With Schizophrenia

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