Modification of Cognitive Processing Therapy (CPT-C) for PTSD and Alcohol Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Yale University
Information provided by (Responsible Party):
Yale University Identifier:
First received: March 13, 2008
Last updated: September 14, 2015
Last verified: September 2015

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
Other: modified CPT-C
Phase 2
Phase 3

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:

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: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
modified CPT-C
Other: modified CPT-C
modified CPT-C


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

Inclusion Criteria:

  1. Males and females between the ages of 21-65 years old.
  2. 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.
  3. Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS; Blake et al. 1995).
  4. Participants on psychiatric medication must be on a stable regimen for at least 2 weeks before treatment begins.
  5. Ability to participate psychologically and physically, able to give informed consent and complete assessments, and participate in study procedures.

Exclusion Criteria:

  1. Current psychotic disorders
  2. Current suicidal or homicidal ideations
  3. Current substance dependence other than alcohol or nicotine dependence
  4. Legal charges pending with potential of incarceration
  5. Unstable serious medical conditions or one requiring acute medical treatments or anticipation of hospitalization for extended care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00639288

Contact: Mayumi Gianoli, Ph.D. 860-666-6951 ext 6511
Contact: Elizabeth Ralevski, Ph.D. 203-932-5711 ext 4282

United States, Connecticut
VA Connecticut Healthcare System - West Haven Campus Recruiting
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Principal Investigator: Ismene L Petrakis, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University Identifier: NCT00639288     History of Changes
Other Study ID Numbers: IP0036, MIRECC
Study First Received: March 13, 2008
Last Updated: September 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Alcohol Dependence

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Alcohol-Related Disorders
Anxiety Disorders
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Substance-Related Disorders processed this record on November 27, 2015