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

NCT ID: NCT00639288

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2015-04-30

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.

Conditions

Alcohol Dependence; PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

modified CPT-C

Group Type: EXPERIMENTAL

modified CPT-C

Intervention Type: OTHER

modified CPT-C

Interventions

modified CPT-C

modified CPT-C

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ismene L Petrakis, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

MIRECC

Identifier Type: -

Identifier Source: secondary_id

IP0036

Identifier Type: -

Identifier Source: org_study_id