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

NCT ID: NCT01409707

Last Updated: 2014-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Dependence Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Healthy lifestyles sessions

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Trauma-focused exposure therapy

Intervention Type BEHAVIORAL

cognitive behavioral therapy for PTSD

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.

Group Type EXPERIMENTAL

Motivational enhancement + trauma-focused exposure therapy

Intervention Type BEHAVIORAL

Cognitive behavioral therapy for PTSD

Interventions

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Trauma-focused exposure therapy

cognitive behavioral therapy for PTSD

Intervention Type BEHAVIORAL

Motivational enhancement + trauma-focused exposure therapy

Cognitive behavioral therapy for PTSD

Intervention Type BEHAVIORAL

Healthy lifestyles sessions

Intervention Type BEHAVIORAL

Other Intervention Names

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Prolonged exposure Trauma-focused motivational enhancement therapy Prolonged Exposure Motivational Interviewing

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Scott F. Coffey

Professor and Director, Division of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott F. Coffey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA016816

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007-0071

Identifier Type: -

Identifier Source: org_study_id

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