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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00639288
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Alcohol Dependence PTSD Other: modified CPT-C Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modification of Cognitive Processing Therapy (CPT-C) for Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence (AD)
Study Start Date : March 2008
Primary Completion Date : October 2014
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
modified CPT-C
Other: modified CPT-C
modified CPT-C


Outcome Measures

Primary Outcome Measures :
  1. Alcohol use, PTSD symptoms [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639288


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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00639288     History of Changes
Other Study ID Numbers: IP0036
MIRECC
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016

Keywords provided by Yale University:
Alcohol Dependence
PTSD
CPT-C

Additional relevant MeSH terms:
Alcoholism
Stress Disorders, Post-Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs