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OpenTrials
Completed

NCT Number: NCT01409707

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma-focused exposure therapy

Behavioral

cognitive behavioral therapy for PTSD

Other names: Prolonged exposure

Motivational enhancement + trauma-focused exposure therapy

Behavioral

Cognitive behavioral therapy for PTSD

Other names: Trauma-focused motivational enhancement therapy, Prolonged Exposure, Motivational Interviewing

Healthy lifestyles sessions

Behavioral

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Aug 4, 2011
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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