Intervention for Veterans With Depression, Substance Disorder, and Trauma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00958217
First received: August 11, 2009
Last updated: February 22, 2016
Last verified: February 2016
Results First Received: June 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Depressive Symptoms
Substance-related Disorders
Posttraumatic Stress Disorders
Interventions: Behavioral: Cognitive Processing Therapy-Modified (CPT-M)
Behavioral: Integrated Cognitive Behavioral Therapy (ICBT)

  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
Veterans referred to a VA dual diagnosis outpatient clinic who were diagnosed with depressive disorder, substance use disorder, and had a history of trauma (with and without a posttraumatic stress disorder diagnosis) were recruited from December 2009 through October 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants engaged in 12 weeks of group Integrated Cognitive Behavioral Therapy and were then randomized to the individual study interventions. 31 participants were not randomized (3 died, 6 moved, 6 withdrew, 4 lost, 4 not stable, 4 did not meet study criteria, 4 sober living facility did not allow).

Reporting Groups
  Description
Arm 1: Cognitive Processing Therapy- Modified

Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.

CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.

Arm 2: Integrated Cognitive Behavioral Therapy

Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.

ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse


Participant Flow:   Overall Study
    Arm 1: Cognitive Processing Therapy- Modified     Arm 2: Integrated Cognitive Behavioral Therapy  
STARTED     61     62  
End of Treatment     56 [1]   57 [1]
COMPLETED     37 [2]   37 [2]
NOT COMPLETED     24     25  
Death                 2                 1  
Withdrawal by Subject                 4                 3  
Lost to Follow-up                 17                 19  
Moved out of area                 1                 1  
Inpatient hospitalization                 0                 1  
[1] Participants had a maximum of 16 weeks to complete 12 individual psychotherapy sessions
[2] Participants were assessed quarterly for one year following end of treatment



  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
Arm 1: CPT-M

Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited.

CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills.

Arm 2: ICBT

Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited.

ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse

Total Total of all reporting groups

Baseline Measures
    Arm 1: CPT-M     Arm 2: ICBT     Total  
Number of Participants  
[units: participants]
  61     62     123  
Age  
[units: years]
Mean (Standard Deviation)
  47.2  (12.1)     47.3  (11.9)     47.3  (12.0)  
Gender  
[units: participants]
     
Female     6     8     14  
Male     55     54     109  
PTSD Current diagnosis  
[units: participants]
     
with PTSD diagnosis     51     50     101  
without PTSD diagnosis     10     12     22  



  Outcome Measures
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1.  Primary:   Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.   [ Time Frame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) ]

2.  Primary:   Posttraumatic Stress Disorder (PTSD) Symptoms   [ Time Frame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) ]

3.  Primary:   Timeline Followback   [ Time Frame: Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 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:  
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: Susan R. Tate, Ph.D., Clinical Psychologist
Organization: VA San Diego Healthcare System/UCSD
phone: 619-426-9402
e-mail: srtate@ucsd.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00958217     History of Changes
Other Study ID Numbers: MHBA-016-09S
Study First Received: August 11, 2009
Results First Received: June 26, 2015
Last Updated: February 22, 2016
Health Authority: United States: Federal Government