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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:
NCT00639288
First received: March 13, 2008
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  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 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:

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: August 2012
Estimated Primary Completion Date: August 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:

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

Locations
United States, Connecticut
VA Connecticut Healthcare System - West Haven Campus
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: August 30, 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 May 19, 2013