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

NCT00622921 | Withdrawn Phase 2

• 1 other identifier: 0711003228
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Alcohol Dependence

Keywords

PTSD; alcohol dependence

Outcome Measures

Primary Outcomes (1)

• PTSD symptoms, Alcohol use

  12 weeks

Secondary Outcomes (1)

• relationship functioning

  12 weeks

Study Arms (1)

1

OTHER

Couples-based behavioral psychotherapy

Behavioral: Couples-based behavioral psychotherapy

Interventions

Couples-based behavioral psychotherapy BEHAVIORAL

12 weeks of Couples-based behavioral psychotherapy

1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Ismene L Petrakis, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

US (1)