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

NCT00639288 | Completed Phase 2

• 2 other identifiers: IP0036MIRECC
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Alcohol Dependence; PTSD; CPT-C

Outcome Measures

Primary Outcomes (1)

• Alcohol use, PTSD symptoms

  16 weeks

Secondary Outcomes (1)

• quality of life

  16 weeks

Study Arms (1)

1

EXPERIMENTAL

modified CPT-C

Other: modified CPT-C

Interventions

modified CPT-C OTHER

modified CPT-C

1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Ismene L Petrakis, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2008
• First Posted: March 20, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: April 1, 2015
• Last Updated: March 21, 2016

Record last verified: 2016-03

Locations

US (1)