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Building Recovery By Improving Goals, Habits, and Thoughts (BRIGHT)

This study has been completed.
Sponsor:
Collaborator:
Behavioral Health Services, Inc.
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT01191788
First received: June 29, 2010
Last updated: May 22, 2012
Last verified: May 2012
Results First Received: October 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Depression
Substance Use
Interventions: Behavioral: Group Cognitive Behavioral Therapy
Behavioral: Group CBT for Depression

  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
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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
Group CBT Clients received up to 16 sessions of group CBT for depression
Comparison Treatment as Usual comparison condition

Participant Flow:   Overall Study
    Group CBT   Comparison
STARTED   140   159 
COMPLETED   119 [1]   137 [1] 
NOT COMPLETED   21   22 
Lost to Follow-up                21                22 
[1] Completed 3-month followup



  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.
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Reporting Groups
  Description
Group CBT Clients received up to 16 sessions of group CBT for depression
Comparison Treatment as Usual comparison condition
Total Total of all reporting groups

Baseline Measures
   Group CBT   Comparison   Total 
Overall Participants Analyzed 
[Units: Participants]
 140   159   299 
Age 
[Units: Participants]
     
<=18 years   1   0   1 
Between 18 and 65 years   139   159   298 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.31  (10.08)   37.04  (10.53)   36.23  (10.34) 
Gender 
[Units: Participants]
     
Female   70   74   144 
Male   70   85   155 
Region of Enrollment 
[Units: Participants]
     
United States   140   159   299 


  Outcome Measures
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1.  Primary:   Depressive Symptoms as Measured by the Beck Depression Inventory II   [ Time Frame: 3 Months Post Treatment ]

2.  Secondary:   Mental Health Functioning as Measured by SF-12 MCS.   [ Time Frame: 3 Months Post Treatment ]


  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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