Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Scott F. Coffey, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01409707
First received: August 2, 2011
Last updated: January 28, 2014
Last verified: January 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Posttraumatic Stress Disorder
Interventions: Behavioral: Trauma-focused exposure therapy
Behavioral: Motivational enhancement + trauma-focused exposure therapy
Behavioral: Healthy lifestyles sessions

  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
Recruitment occurred at a residential substance abuse treatment facility between July 2008 and June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
222 assessed; 96 ineligible. 53 did not have current PTSD, 6 did not have current alcohol dependence (AD), and 2 did not have either current PTSD or AD. 35 participants were ineligible for other reasons (e.g., current mania, current psychosis, etc.).

Reporting Groups
  Description
Healthy Lifestyles Sessions Healthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
Trauma-focused Exposure Therapy Trauma-focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma-focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
Motivational Enhancement + Trauma-focused Exposure Therapy A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. Exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.

Participant Flow:   Overall Study
    Healthy Lifestyles Sessions     Trauma-focused Exposure Therapy     Motivational Enhancement + Trauma-focused Exposure Therapy  
STARTED     41     45     40  
COMPLETED     36     28     24  
NOT COMPLETED     5     17     16  
Withdrawal by Subject                 5                 17                 16  



  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
Healthy Lifestyles Sessions HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
Trauma-focused Exposure Therapy EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
Motivational Enhancement + Trauma-focused Exposure Therapy A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
Total Total of all reporting groups

Baseline Measures
    Healthy Lifestyles Sessions     Trauma-focused Exposure Therapy     Motivational Enhancement + Trauma-focused Exposure Therapy     Total  
Number of Participants  
[units: participants]
  41     45     40     126  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     41     45     40     126  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.85  ± 10.67     34.67  ± 10.33     34.40  ± 10.65     33.72  ± 10.25  
Gender  
[units: participants]
       
Female     21     19     18     58  
Male     20     26     22     68  
Region of Enrollment  
[units: participants]
       
United States     41     45     40     126  



  Outcome Measures
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1.  Primary:   Impact of Event Scale-Revised   [ Time Frame: 3-months posttreatment ]

2.  Primary:   Timeline Follow Back   [ Time Frame: 3-months posttreatment ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
Unclear whether results will generalize to outpatient sample.  


Results Point of Contact:  
Name/Title: Dr. Scott Coffey
Organization: University of Mississippi Medical Center
phone: 601-815-5588
e-mail: scoffey@umc.edu


No publications provided


Responsible Party: Scott F. Coffey, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01409707     History of Changes
Other Study ID Numbers: 2007-0071, R01AA016816
Study First Received: August 2, 2011
Results First Received: October 29, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board