Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Cognitive Behavior Therapy and Work Outcome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00810355
First received: December 16, 2008
Last updated: September 13, 2016
Last verified: September 2016
Results First Received: July 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Behavioral: Support Group
Behavioral: Cognitive Behavior Therapy
Behavioral: Cognitive Remediation

  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
12 subjects consented, but failed to complete intake procedures for randomization. This is why the final results total enrollment number differs from the protocol enrollment number.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Support Group Support Group: General support and problem solving for work activity
Cognitive Behavior Therapy Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
Cognitive Behavior Therapy and Cognitive Remediation

Support Group: General support and problem solving for work activity

Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work

Cognitive Remediation: Computerized training to enhance cognitive functioning.


Participant Flow:   Overall Study
    Support Group   Cognitive Behavior Therapy   Cognitive Behavior Therapy and Cognitive Remediation
STARTED   25   25   25 
COMPLETED   11   8   14 
NOT COMPLETED   14   17   11 
Lost to Follow-up                13                17                11 
Withdrawal by Subject                1                0                0 



  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
Support Group

Support group

Support Group: General support and problem solving for work activity

Cognitive Behavior Therapy

Cognitive Behavior Therapy

Support Group: General support and problem solving for work activity

Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work

Cognitive Behavior Therapy and Cognitive Remediation

Cognitive Behavior Therapy and Cognitive Remediation

Support Group: General support and problem solving for work activity

Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work

Cognitive Remediation: Computerized training to enhance cognitive functioning.

Total Total of all reporting groups

Baseline Measures
   Support Group   Cognitive Behavior Therapy   Cognitive Behavior Therapy and Cognitive Remediation   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   25   75 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   23   25   25   73 
>=65 years   2   0   0   2 
Gender 
[Units: Participants]
       
Female   1   2   1   4 
Male   24   23   24   71 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   15   14   15   44 
White   10   11   9   30 
More than one race   0   0   1   1 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   25   25   25   75 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Work Quality   [ Time Frame: 6 months ]

2.  Primary:   Work Quantity   [ Time Frame: 6 months ]

3.  Primary:   Symptoms   [ Time Frame: 6 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Paul Lysaker
Organization: Richard L. Roudebush VA Medical Center
phone: 317-988-2546
e-mail: paul.lysaker@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00810355     History of Changes
Other Study ID Numbers: D6629-R
Study First Received: December 16, 2008
Results First Received: July 22, 2016
Last Updated: September 13, 2016
Health Authority: United States: Federal Government