Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence
This study has been withdrawn prior to enrollment.
Sponsor:
Elizabeth Ralevski
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
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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
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 May 19, 2013