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Clinical Trials/NCT00639288
NCT00639288CompletedPhase 2

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

Yale University1 site in 1 country9 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
9
Locations
1
Primary Endpoint
Alcohol use, PTSD symptoms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

modified CPT-C

Intervention: modified CPT-C (Other)

Outcomes

Primary Outcomes

Alcohol use, PTSD symptoms

Time Frame: 16 weeks

Secondary Outcomes

  • quality of life(16 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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