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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:
NCT00622921
First received: February 13, 2008
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
PTSD
Alcohol Dependence
Behavioral: Couples-based behavioral psychotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • PTSD symptoms, Alcohol use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relationship functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Couples-based behavioral psychotherapy
Behavioral: Couples-based behavioral psychotherapy
12 weeks of Couples-based behavioral psychotherapy

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622921

Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Elizabeth Ralevski
Investigators
Principal Investigator: Ismene L Petrakis, MD Yale University
  More Information

No publications provided

Responsible Party: Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00622921     History of Changes
Other Study ID Numbers: IP0031, 0711003228
Study First Received: February 13, 2008
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
PTSD
alcohol dependence

Additional relevant MeSH terms:
Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on July 29, 2014