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

This study has been completed.

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

History of Changes

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 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:

MedlinePlus related topics: Alcoholism and Alcohol Abuse Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by Scott F. Coffey, University of Mississippi Medical Center:

Primary Outcome Measures:

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.


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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators


Principal Investigator:	Scott F. Coffey, Ph.D.	University of Mississippi Medical Center

More Information


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 )
Study First Received:	August 2, 2011
Results First Received:	October 29, 2013
Last Updated:	January 28, 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

ClinicalTrials.gov processed this record on July 21, 2017

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