Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
2 other identifiers
interventional
126
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
March 10, 2014
CompletedMarch 10, 2014
January 1, 2014
3.5 years
August 2, 2011
October 29, 2013
January 28, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Impact of Event Scale-Revised
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.
3-months posttreatment
Timeline Follow Back
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.
3-months posttreatment
Study Arms (3)
Healthy lifestyles sessions
EXPERIMENTALHealthy 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
EXPERIMENTALTrauma 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.
Motivational enhancement + trauma-focused exposure therapy
EXPERIMENTALA 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.
Interventions
cognitive behavioral therapy for PTSD
Cognitive behavioral therapy for PTSD
Eligibility Criteria
You may qualify if:
- Current PTSD
- Current Alcohol Dependence
- at least one heavy drinking day in the past 60 days
You may not qualify if:
- Psychotic disorder
- Untreated bi-polar disorder
- benzodiazepine use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Unclear whether results will generalize to outpatient sample.
Results Point of Contact
- Title
- Dr. Scott Coffey
- Organization
- University of Mississippi Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Scott F. Coffey, Ph.D.
University of Mississippi Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Director, Division of Psychology
Study Record Dates
First Submitted
August 2, 2011
First Posted
August 4, 2011
Study Start
July 1, 2008
Primary Completion
January 1, 2012
Study Completion
May 1, 2013
Last Updated
March 10, 2014
Results First Posted
March 10, 2014
Record last verified: 2014-01