A Modified Version of Cognitive Processing Therapy for Treatment of Patients Diagnosed With Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence or Alcohol Abuse

This study is currently recruiting participants.

Verified by Yale University, June 2009

First Received: March 13, 2008 Last Updated: June 10, 2009 History of Changes

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00639288

Purpose

Objective: To evaluate the efficacy of a modified version of cognitive processing therapy - cognitive (CPT-C) versus historical controls in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid posttraumatic stress disorder (PTSD) and alcohol dependence or alcohol abuse.

Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days (measured by the Timeline Follow Back Method [TLFB]) and reduce the symptoms of PTSD (measured by the [CAPS and PCL] scores) compared to historical controls in patients with alcohol dependence or alcohol abuse and PTSD.

Design: This is a 12-week outpatient intervention of modified CPT-C versus treatment as usual in individuals with PTSD and alcohol dependence or alcohol abuse. Treatment consists of weekly sessions lasting approximately 60 minutes.

Condition	Intervention	Phase
Alcohol Dependence PTSD	Other: modified CPT-C	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Use of a Modified Version of Cognitive Processing Therapy for the Treatment of Patients Diagnosed With Posttraumatic Stress Disorder and Alcohol Dependence or Alcohol Abuse

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Post-Traumatic Stress Disorder

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Alcohol use, PTSD symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator modified CPT-C	Other: modified CPT-C modified CPT-C

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females between the ages of 21-65 years old.
Current alcohol dependence or alcohol abuse, as determined by the Structured Clinical Interview for DSM-IV Axis I Disorder (SCID; First et al. 1996). Not requiring detoxification from alcohol and able to remain abstinent for 3 days prior to treatment, and the stated goal of study is abstinence. Abstinence no more than past 29 days. Primary substance dependence diagnosis of alcohol dependence or alcohol abuse.
Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS; Blake et al. 1995).
Participants on psychiatric medication must be on a stable regimen for at least 2 weeks before treatment begins.
Veteran eligible for VA services.
Ability to participate psychologically and physically, able to give informed consent and complete assessments, and participate in study procedures.

Exclusion Criteria:

Psychotic symptoms as determined by the SCID.
Serious current psychiatric symptoms, such as suicidal ideation or homicidal ideation.
Opioid dependence as determined by the SCID.
Legal charges pending with potential of incarceration.
Unstable, serious medical condition or one requiring acute medical treatments, or anticipation of hospitalization for extended care.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639288

Contacts

Contact: Elissa McCarthy, Ph.D.	203-932-5711 ext 7437	elissa.mccarthy@va.gov
Contact: Elizabeth Ralevski, Ph.D.	203-932-5711 ext 4282	elizabeth.ralevski@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System - West Haven Campus	Recruiting
West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Ismene L Petrakis, MD

Yale University

More Information

No publications provided

Responsible Party:	Yale Univerisity ( Ismene Petrakis )
Study ID Numbers:	IP0031, MIRECC
Study First Received:	March 13, 2008
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00639288 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Alcohol Dependence or Abuse
PTSD
CPT-C

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Stress Disorders, Post-Traumatic
Stress
Alcohol-Related Disorders
Stress Disorders, Traumatic
Ethanol

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Stress Disorders, Post-Traumatic
Alcohol-Related Disorders
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on September 10, 2009