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A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity

9. september 2013 opdateret af: Professor Paul Haber, South West Sydney Local Health District

Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity

There is a high rate of psychological comorbidity in people suffering from alcohol dependence. There is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety or depression. This study will test the efficacy of a novel integrated intervention for comorbid alcohol dependence and anxiety or mood disorder.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In summary, the specific aims of this project are:

  1. To assess the effectiveness of a novel stepped care intervention for alcohol dependent patients with co-morbid anxiety and/or depression compared to usual treatment for alcohol dependence in promoting abstinence from alcohol and increased quality of life and in reducing symptoms of anxiety and depression.
  2. To describe important factors relating to the maintenance of alcohol-related psychiatric comorbidity.

Step 1: All subjects will complete 12 weeks of pharmacotherapy (n = 120) on naltexone (50 mg, 1 tablet daily), acamprosate (333 mg, 2 tablets 3 times daily, reduced to 4/day for women <65kg), or a combination of the two. After a 3 week stabilization period, subjects will undergo complete formal assessment for anxiety and depression. Those subjects with a diagnosis of anxiety or depressive disorder regardless of drinking outcome will be offered the next step of care and followed up at 12-16 weeks.

Step 2: Subjects to undergo the next step of care (n = 30 per group, 60 in total) will be randomized by referring to the consecutively assigned subject identification number to a matched numbered envelope containing a random assignment card. Randomization will be stratified according to concomitant SSRI use. The treatment groups will be:

  1. Intervention for comorbid anxiety or depression, and
  2. Usual counseling care.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

86

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • New South Wales
      • Sydney, New South Wales, Australien, 2050
        • Drug Health Services, Royal Prince Alfred Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria for Step 1:

  • alcohol dependence according to DSM-IV criteria, with alcohol as the subject's drug of choice,
  • age 18-65,
  • adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination),
  • willingness to give written consent,
  • abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone),
  • resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC).

Exclusion Criteria for Step 1:

  • sensitivity to study medications or therapy with these drugs within 6 months,
  • active major psychiatric disorder associated with significant suicide risk,
  • pregnancy or lactation,
  • advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy),
  • other serious medical illness that would interfere with adherence to the study protocol.

Entry criteria to step 2:

  • Completion of 3 weeks on acamprosate and/or natlrexone and/or, resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale),
  • case formulation and diagnosis for anxiety or depression (see below).

Exclusion criteria 2:

  • Non-compliance on acamprosate and/or naltrexone,
  • alcohol consumption at baseline levels,
  • resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Sædvanlig pleje
Adfærdsmæssigt: Usual care
Counselling for all subjects will continue in accord with standard practice. Currently, programs of brief individualized motivation enhancement therapy (feedback of assessment findings, reinforcement, empathy, client's own motivation) are available.
Eksperimentel: Integrated care

Integrated care:

Intervention for co-morbid alcohol dependence and anxiety or mood disorder. Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders.
Adfærdsmæssigt: Integrated care
Intervention for co-morbid alcohol dependence and anxiety or mood disorder. Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Alcohol consumption
Tidsramme: 12 weeks
Time to relapse (>5 drinks on any one day)
12 weeks
Time to lapse
Tidsramme: 12 weeks
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
12 weeks
amount of alcohol consumption
Tidsramme: 12 weeks
expressed as the average consumption per drinking day
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in depressive or anxiety symptoms
Tidsramme: 12 weeks
DASS 21
12 weeks
Diagnosis severity
Tidsramme: 16 weeks
clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.
16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

South West Sydney Local Health District

Samarbejdspartnere

University of Sydney

Efterforskere

  • Ledende efterforsker: Andrew Baillie, Macquarie University
  • Ledende efterforsker: Paul Haber, University of Sydney

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2007

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

5. september 2013

Først indsendt, der opfyldte QC-kriterier

9. september 2013

Først opslået (Skøn)

13. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • X05-0279

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 .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner