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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00622921
First Posted: February 25, 2008
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University
  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
Intervention Model: Single Group Assignment
Masking: None (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 Elizabeth Ralevski, Yale University:

Primary Outcome Measures:
  • PTSD symptoms, Alcohol use [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • relationship functioning [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00622921     History of Changes
Other Study ID Numbers: IP0031
0711003228
First Submitted: February 13, 2008
First Posted: February 25, 2008
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Elizabeth Ralevski, Yale University:
PTSD
alcohol dependence

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Alcoholism
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs