- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00622921
Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Connecticut
-
West Haven, Connecticut, Förenta staterna, 06516
- VA Connecticut Healthcare System
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 1
Couples-based behavioral psychotherapy
|
12 weeks of Couples-based behavioral psychotherapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
PTSD symptoms, Alcohol use
Tidsram: 12 weeks
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
relationship functioning
Tidsram: 12 weeks
|
12 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0711003228
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