Conditions:
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.
Dates: February 2008 -
Study Status: Recruiting
Ages Eligible: 21 Years - 65 Years
Gender Eligible: Male
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.
Sponsor:
Phase: Phase 2/Phase 3
First Received: February 13, 2008
Last Updated: Feb 07, 2009
Clinicaltrials.gov ID:
NCT00622921
Study HIC # 0711003228
Conditions:
Intervention: Behavioral: Couples-based behavioral psychotherapy
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.
Dates: February 2008 -
Study Status: Recruiting
Ages Eligible: 21 Years - 65 Years
Gender Eligible: Male
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.
Sponsor:
Phase: Phase 2/Phase 3
First Received: February 13, 2008
Last Updated: Feb 07, 2009
Clinicaltrials.gov ID:
NCT00622921
Study HIC # 0711003228
Barbara C Moore, Ph.D.
203-606-4767
barbara.moore@yale.edu
Elizabeth Ralevski, Ph.D.
203-932-5711 Ext. 4282
elizabeth.ralevski@yale.edu
Petrakis, Ismene Leonida
Principal Investigator
HIC # 0805003779