Modification of Cognitive Processing Therapy (CPT-C) for Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence (AD)

This study is currently recruiting participants.

Verified January 2012 by Yale University

First Received on March 13, 2008. Last Updated on January 26, 2012 History of Changes

Sponsor:	Elizabeth Ralevski
Information provided by (Responsible Party):	Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:	NCT00639288

Purpose

Objective: To develop a detailed treatment manual that modifies the existing CPT-C treatment protocol to allow for concurrent treatment of PTSD and AD, and to obtain some pilot data regarding its efficacy.

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).

Design: This is a non-randomized, prospective study in which all participants will receive the modified CPT-C for 12 weeks by trained CPT-C clinicians, with each session lasting approximately 1-1.5 hours). Modifications to CPT-C include psychoeducation about alcohol use as an avoidance of PTSD symptoms integrated throughout treatment, integration of coping skills training for AD, weekly breathalyzer tests to measure blood alcohol level, and use and collection of daily dairies of alcohol use.

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Modification of Cognitive Processing Therapy (CPT-C) for Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence (AD)

Resource links provided by NLM:

MedlinePlus related topics: Alcohol 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: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 as determined by the Structured Clinical Interview for DSM-IV Axis I Disorder (SCID; First et al. 1996). Abstinence no more than past 29 days. Primary substance dependence diagnosis of alcohol dependence.
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.
Ability to participate psychologically and physically, able to give informed consent and complete assessments, and participate in study procedures.

Exclusion Criteria:

Current psychotic disorders
Current suicidal or homicidal ideations
Current substance dependence other than alcohol or nicotine dependence
Legal charges pending with potential of incarceration
Unstable serious medical conditions 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: Mayumi Gianoli, Ph.D.	860-666-6951 ext 6511	may.gianoli@yale.edu
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

Elizabeth Ralevski

Investigators

Principal Investigator:

Ismene L Petrakis, MD

Yale University

More Information

No publications provided

Responsible Party:	Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier:	NCT00639288 History of Changes
Other Study ID Numbers:	IP0036, MIRECC
Study First Received:	March 13, 2008
Last Updated:	January 26, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Alcohol Dependence
PTSD
CPT-C

Additional relevant MeSH terms:

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

Substance-Related Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on February 09, 2012