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Cognitive Behavior Therapy and Work Outcome

This study has been completed.
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: April 12, 2017
Last verified: April 2017
Results First Received: July 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Behavioral: Support Group
Behavioral: Cognitive Behavior Therapy
Behavioral: Cognitive Remediation

  Participant Flow
  Hide Participant Flow

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
No text entered.

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]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      23  92.0%      25 100.0%      25 100.0%      73  97.3% 
>=65 years      2   8.0%      0   0.0%      0   0.0%      2   2.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1   4.0%      2   8.0%      1   4.0%      4   5.3% 
Male      24  96.0%      23  92.0%      24  96.0%      71  94.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      15  60.0%      14  56.0%      15  60.0%      44  58.7% 
White      10  40.0%      11  44.0%      9  36.0%      30  40.0% 
More than one race      0   0.0%      0   0.0%      1   4.0%      1   1.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      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
  Hide Limitations and Caveats

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
No text entered.


  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: April 12, 2017