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
  Purpose

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.


Condition Intervention
Alcohol Dependence
Posttraumatic Stress Disorder
Behavioral: Trauma-focused exposure therapy
Behavioral: Motivational enhancement + trauma-focused exposure therapy
Behavioral: Healthy lifestyles sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 126
Study Start Date: July 2008
Study Completion Date: May 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Behavioral: Trauma-focused exposure therapy
cognitive behavioral therapy for PTSD
Other Name: Prolonged exposure
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.
Behavioral: Motivational enhancement + trauma-focused exposure therapy
Cognitive behavioral therapy for PTSD
Other Names:
  • Trauma-focused motivational enhancement therapy
  • Prolonged Exposure
  • Motivational Interviewing

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409707

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Scott F. Coffey, Ph.D. University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Scott F. Coffey, Professor and Director, Division of Psychology, 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

Additional relevant MeSH terms:
Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on April 17, 2014