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Completed

NCT Number: NCT00639288

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

modified CPT-C

Other

modified CPT-C

Primary outcomes

  1. Alcohol use, PTSD symptoms

    Time frame: 16 weeks

Secondary outcomes

  1. quality of life

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Mar 20, 2008
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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