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
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, PTSD, CPT-C
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
Sites / Locations
- VA Connecticut Healthcare System - West Haven Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
modified CPT-C
Outcomes
Primary Outcome Measures
Alcohol use, PTSD symptoms
Secondary Outcome Measures
quality of life
Full Information
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
No
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
1
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
No
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
Learn more about this trial
Modification of Cognitive Processing Therapy (CPT-C) for PTSD and Alcohol Dependence
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