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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409707
• Other study ID #: 2007-0071
• Secondary ID: R01AA016816
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: January 28, 2014
• Start date: July 2008
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma-focused exposure therapy
cognitive behavioral therapy for PTSD
• Motivational enhancement + trauma-focused exposure therapy
Cognitive behavioral therapy for PTSD
• Healthy lifestyles sessions

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No