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

August 2, 2011
January 28, 2014
July 2008
January 2012   (final data collection date for primary outcome measure)
  • Impact of Event Scale-Revised [ Time Frame: 3-months posttreatment ] [ Designated as safety issue: No ]
    The Impact of Event Scale-Revised is a 22-item self-report measure of posttraumatic stress disorder symptoms. The total score for the Impact of Event Scale-Revised ranges from 0 to 88 with lower scores representing less severe symptoms of posttraumatic stress disorder and higher scores representing more severe symptoms of posttraumatic stress disorder.
  • Timeline Follow Back [ Time Frame: 3-months posttreatment ] [ Designated as safety issue: No ]
    The timeline follow back is a measure of drug and alcohol consumption in the prior 90 days. The timeline follow back is a calendar-based retrospective account of drug and alcohol consumption for a specified period of time (e.g., past 90 days). One of the most commonly reported metrics of drug and alcohol consumption from this measure is percent days abstinent (PDA). Percent days abstinent is simply the proportion of days for the specified period of time (e.g., 90 days) in which drugs or alcohol were not consumed. Percent days abstinent can range from 0 to 100 with 0 representing no abstinence during a specified period of time (i.e., consumed alcohol every day) and 100 representing complete abstinence during a specified period of time.
  • Impact of Event Scale-Revised [ Time Frame: one-week ] [ Designated as safety issue: No ]
    Measure of PTSD symptoms.
  • Timeline Follow Back [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Drug and alcohol consumption in the prior 90 days
Complete list of historical versions of study NCT01409707 on ClinicalTrials.gov Archive Site
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Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD

The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Alcohol Dependence
  • Posttraumatic Stress Disorder
  • Behavioral: Trauma-focused exposure therapy
    cognitive behavioral therapy for PTSD
    Other Name: Prolonged exposure
  • Behavioral: Motivational enhancement + trauma-focused exposure therapy
    Cognitive behavioral therapy for PTSD
    Other Names:
    • Trauma-focused motivational enhancement therapy
    • Prolonged Exposure
    • Motivational Interviewing
  • Behavioral: Healthy lifestyles sessions
  • Experimental: 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.
    Intervention: Behavioral: Healthy lifestyles sessions
  • Experimental: 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 posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.
    Intervention: Behavioral: Trauma-focused exposure therapy
  • Experimental: 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. 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 posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.
    Intervention: Behavioral: Motivational enhancement + trauma-focused exposure therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
May 2013
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current PTSD
  • Current Alcohol Dependence
  • at least one heavy drinking day in the past 60 days

Exclusion Criteria:

  • Psychotic disorder
  • Untreated bi-polar disorder
  • benzodiazepine use
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01409707
2007-0071, R01AA016816
No
Scott F. Coffey, University of Mississippi Medical Center
University of Mississippi Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Scott F. Coffey, Ph.D. University of Mississippi Medical Center
University of Mississippi Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP