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

Primary Purpose

Alcohol Dependence, PTSD

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

modified CPT-C

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, PTSD, CPT-C

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Connecticut Healthcare System - West Haven Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

modified CPT-C

Outcomes

Primary Outcome Measures

Alcohol use, PTSD symptoms

Secondary Outcome Measures

quality of life

Full Information

NCT ID

NCT00639288

First Posted

March 13, 2008

Last Updated

March 18, 2016

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT00639288

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence, PTSD

Keywords

Alcohol Dependence, PTSD, CPT-C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

modified CPT-C

Intervention Type

Other

Intervention Name(s)

modified CPT-C

Intervention Description

modified CPT-C

Primary Outcome Measure Information:

Title

Alcohol use, PTSD symptoms

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

quality of life

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ismene L Petrakis, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Connecticut Healthcare System - West Haven Campus

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

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

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