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

Phase 2

Completed

• Conditions: PTSD; Alcohol Dependence
• Interventions: Other: modified CPT-C

• Registration Number: NCT00639288
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-13
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Primary Completion: 2014-10
• Study Completion: 2015-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	modified CPT-C	modified CPT-C

Primary Outcome Measures

Name	Time	Method
Alcohol use, PTSD symptoms	16 weeks

Secondary Outcome Measures

Name	Time	Method
quality of life	16 weeks

Trial Locations

Locations (1)

VA Connecticut Healthcare System - West Haven Campus; 🇺🇸 West Haven, Connecticut, United States