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Trial record 1 of 1 for:    22939029 [PUBMED-IDS]
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Cognitive Training for Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01521026
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
ETwamley, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Other Primary Psychotic Disorders
Intervention Behavioral: Cognitive Training
Enrollment 69

Recruitment Details Participants included 89 community-dwelling outpatients. Inclusion criteria were: primary psychotic disorder, age 18 or older, and fluency in English. Exclusion criteria were: dementia, neurological conditions affecting cognition, mental retardation, substance use disorder within the past month, and participation in other intervention trials.
Pre-assignment Details Baseline data were collected before randomization.
Arm/Group Title Cognitive Training Standard Pharmacotherapy
Hide Arm/Group Description Cognitive training group Standard pharmacotherapy with regular clinician
Period Title: Overall Study
Started 38 31
Completed 23 28
Not Completed 15 3
Arm/Group Title Cognitive Training Standard Pharmacotherapy Total
Hide Arm/Group Description Cognitive training group standard pharmacotherapy with regular clinician Total of all reporting groups
Overall Number of Baseline Participants 38 31 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 31 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  97.4%
31
 100.0%
68
  98.6%
>=65 years
1
   2.6%
0
   0.0%
1
   1.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 31 participants 69 participants
44.3  (10.1) 48.8  (8.7) 46.3  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 31 participants 69 participants
Female
14
  36.8%
10
  32.3%
24
  34.8%
Male
24
  63.2%
21
  67.7%
45
  65.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 31 participants 69 participants
38 31 69
1.Primary Outcome
Title UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training Standard Pharmacotherapy
Hide Arm/Group Description:
Cognitive training group
Standard pharmacotherapy with the regular clinician
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.7  (8.7) 84.4  (8.0)
2.Secondary Outcome
Title Hopkins Verbal Learning Test Percent Retained
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training Standard Pharmacotherapy
Hide Arm/Group Description:
Cognitive training group
Standard pharmacotherapy with the regular clinician
Overall Number of Participants Analyzed 20 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
93.4  (21.6) 85.9  (19.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Training Standard Pharmacotherapy
Hide Arm/Group Description Cognitive training group standard pharmacotherapy with regular clinician
All-Cause Mortality
Cognitive Training Standard Pharmacotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Training Standard Pharmacotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cognitive Training Standard Pharmacotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/31 (0.00%) 
  • small sample size
  • relatively short follow-up period
  • significant dropout rate
  • did not use an active control condition that matched CCT for therapist time or group involvement
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth Twamley, PhD
Organization: UCSD
Phone: 6195436684
Responsible Party: ETwamley, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01521026     History of Changes
Other Study ID Numbers: NARSAD Young Investigator
First Submitted: January 22, 2012
First Posted: January 30, 2012
Results First Submitted: July 1, 2013
Results First Posted: December 11, 2013
Last Update Posted: December 11, 2013