- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Connecticut
-
West Haven, Connecticut, Forenede Stater, 06516
- VA Connecticut Healthcare System
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 1
Couples-based behavioral psychotherapy
|
12 weeks of Couples-based behavioral psychotherapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
PTSD symptoms, Alcohol use
Tidsramme: 12 weeks
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
relationship functioning
Tidsramme: 12 weeks
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0711003228
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .