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Cognitive Training for Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
ETwamley, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01521026
First received: January 22, 2012
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: July 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Other Primary Psychotic Disorders
Intervention: Behavioral: Cognitive Training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Baseline data were collected before randomization.

Reporting Groups
  Description
Cognitive Training Cognitive training group
Standard Pharmacotherapy Standard pharmacotherapy with regular clinician

Participant Flow:   Overall Study
    Cognitive Training     Standard Pharmacotherapy  
STARTED     38     31  
COMPLETED     23     28  
NOT COMPLETED     15     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cognitive Training Cognitive training group
Standard Pharmacotherapy standard pharmacotherapy with regular clinician
Total Total of all reporting groups

Baseline Measures
    Cognitive Training     Standard Pharmacotherapy     Total  
Number of Participants  
[units: participants]
  38     31     69  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     37     31     68  
>=65 years     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  44.3  ± 10.1     48.8  ± 8.7     46.3  ± 9.7  
Gender  
[units: participants]
     
Female     14     10     24  
Male     24     21     45  
Region of Enrollment  
[units: participants]
     
United States     38     31     69  



  Outcome Measures
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1.  Primary:   UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)   [ Time Frame: 3 months ]

2.  Secondary:   Hopkins Verbal Learning Test Percent Retained   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • 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


  More Information
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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
e-mail: etwamley@ucsd.edu


No publications provided by University of California, San Diego

Publications automatically indexed to this study:

Responsible Party: ETwamley, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01521026     History of Changes
Other Study ID Numbers: NARSAD Young Investigator
Study First Received: January 22, 2012
Results First Received: July 1, 2013
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government