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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00639288
• Other study ID #: IP0036
• Secondary ID: MIRECC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 13, 2008
• Last updated: September 14, 2015
• Start date: March 2008
• Est. completion date: October 2016

Study information

• Verified date: September 2015
• Source: Yale University
• Contact: Mayumi Gianoli, Ph.D.
• Phone: 860-666-6951
• Email: may.gianoli[@]yale.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Other:
• modified CPT-C
modified CPT-C

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System - West Haven Campus	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use, PTSD symptoms		16 weeks	Yes
Secondary	quality of life		16 weeks	No