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Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence

Primary Purpose

PTSD, Alcohol Dependence

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Couples-based behavioral psychotherapy
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, alcohol dependence

Eligibility Criteria

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

Inclusion Criteria:

  • Male patients
  • One to six weeks of abstinence from alcohol and other drugs
  • Both partners agree to stated goals of abstinence from alcohol and drugs, reduction of PTSD symptoms, and relationship improvement
  • Current diagnoses of both alcohol dependence and PTSD
  • Receiving treatment for one or both disorders
  • Functionally able to participate in outpatient treatment as determined by P.I. "Functionally able" includes access to transportation.
  • Alcohol is "drug of choice" (History of other drugs acceptable)
  • Married or cohabiting in stable relationship for at least 6 months. Separated couples may participate if attempting to reconcile
  • Patient willing to sign release of information allowing researchers to communicate with patient's clinician regarding treatment goals

Exclusion Criteria:

  • Spouse or partner also has an alcohol or drug problem as determined by P.I. based on report by patient or partner or as revealed on Alcohol Use Disorders Identification Test (AUDIT) or the Drug Abuse Screening Test (DAST) given to partner at intake assessment
  • Mental retardation or learning disorder by clinician report or patient chart
  • Psychotic disorder as determined by patient's chart or SCID
  • Patient currently receiving methadone or another opiate agonist by patient report or chart
  • Current fear of partner or history of severe domestic violence in the past year. An example of severe violence would be a couple reporting an episode of violence that required medical attention. Such couples will be excluded from the study and referred to domestic violence treatment. Couples who have experienced mild to moderate domestic violence may participate in Phase II of the study.

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Couples-based behavioral psychotherapy

Outcomes

Primary Outcome Measures

PTSD symptoms, Alcohol use

Secondary Outcome Measures

relationship functioning

Full Information

First Posted
February 13, 2008
Last Updated
March 31, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00622921
Brief Title
Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence
Official Title
Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

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
Purpose: Phase I focus groups with clinicians and patients will gather qualitative data to focus and inform the content of Phase II. In Phase II, 12 weeks of psychotherapy will be offered to evaluate feasibility and potential efficacy of a couples-based, integrated treatment for men with PTSD and alcohol dependence. Hypotheses: We predict that this experimental psychotherapy, Partners Encouraging Abstinence and Coping with Emotions (PEACE), will reduce patient drinking, reduce PTSD symptoms, and improve relationship functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Alcohol Dependence
Keywords
PTSD, alcohol dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Couples-based behavioral psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Couples-based behavioral psychotherapy
Intervention Description
12 weeks of Couples-based behavioral psychotherapy
Primary Outcome Measure Information:
Title
PTSD symptoms, Alcohol use
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
relationship functioning
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients One to six weeks of abstinence from alcohol and other drugs Both partners agree to stated goals of abstinence from alcohol and drugs, reduction of PTSD symptoms, and relationship improvement Current diagnoses of both alcohol dependence and PTSD Receiving treatment for one or both disorders Functionally able to participate in outpatient treatment as determined by P.I. "Functionally able" includes access to transportation. Alcohol is "drug of choice" (History of other drugs acceptable) Married or cohabiting in stable relationship for at least 6 months. Separated couples may participate if attempting to reconcile Patient willing to sign release of information allowing researchers to communicate with patient's clinician regarding treatment goals Exclusion Criteria: Spouse or partner also has an alcohol or drug problem as determined by P.I. based on report by patient or partner or as revealed on Alcohol Use Disorders Identification Test (AUDIT) or the Drug Abuse Screening Test (DAST) given to partner at intake assessment Mental retardation or learning disorder by clinician report or patient chart Psychotic disorder as determined by patient's chart or SCID Patient currently receiving methadone or another opiate agonist by patient report or chart Current fear of partner or history of severe domestic violence in the past year. An example of severe violence would be a couple reporting an episode of violence that required medical attention. Such couples will be excluded from the study and referred to domestic violence treatment. Couples who have experienced mild to moderate domestic violence may participate in Phase II of the study.
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
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

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Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence

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