Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT01409707 |
Recruitment Status
:
Completed
First Posted
: August 4, 2011
Results First Posted
: March 10, 2014
Last Update Posted
: March 10, 2014
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Condition or disease | Intervention/treatment | Phase |
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Alcohol Dependence Posttraumatic Stress Disorder | Behavioral: Trauma-focused exposure therapy Behavioral: Motivational enhancement + trauma-focused exposure therapy Behavioral: Healthy lifestyles sessions | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | May 2013 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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Behavioral: Trauma-focused exposure therapy
cognitive behavioral therapy for PTSD
Other Name: Prolonged exposure
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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.
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Behavioral: Motivational enhancement + trauma-focused exposure therapy
Cognitive behavioral therapy for PTSD
Other Names:
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- Impact of Event Scale-Revised [ Time Frame: 3-months posttreatment ]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 ]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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409707
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216 |
Principal Investigator: | Scott F. Coffey, Ph.D. | University of Mississippi Medical Center |
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 ( U.S. NIH Grant/Contract ) |
First Posted: | August 4, 2011 Key Record Dates |
Results First Posted: | March 10, 2014 |
Last Update Posted: | March 10, 2014 |
Last Verified: | January 2014 |
Additional relevant MeSH terms:
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Alcoholism Trauma and Stressor Related Disorders |
Mental Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |