A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
연구 개요
상세 설명
In summary, the specific aims of this project are:
- 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.
- 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:
- Intervention for comorbid anxiety or depression, and
- Usual counseling care.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New South Wales
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Sydney, New South Wales, 호주, 2050
- Drug Health Services, Royal Prince Alfred Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 평소 케어
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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.
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실험적: 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. |
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Alcohol consumption
기간: 12 weeks
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Time to relapse (>5 drinks on any one day)
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12 weeks
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Time to lapse
기간: 12 weeks
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time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
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12 weeks
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amount of alcohol consumption
기간: 12 weeks
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expressed as the average consumption per drinking day
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improvement in depressive or anxiety symptoms
기간: 12 weeks
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DASS 21
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12 weeks
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Diagnosis severity
기간: 16 weeks
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clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.
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16 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew Baillie, Macquarie University
- 수석 연구원: Paul Haber, University of Sydney
간행물 및 유용한 링크
일반 간행물
- Morley KC, Baillie A, Leung S, Sannibale C, Teesson M, Haber PS. Is Specialized Integrated Treatment for Comorbid Anxiety, Depression and Alcohol Dependence Better than Treatment as Usual in a Public Hospital Setting? Alcohol Alcohol. 2016 Jul;51(4):402-9. doi: 10.1093/alcalc/agv131. Epub 2015 Dec 15.
- Morley KC, Baillie A, Sannibale C, Teesson M, Haber PS. Integrated care for comorbid alcohol dependence and anxiety and/or depressive disorder: study protocol for an assessor-blind, randomized controlled trial. Addict Sci Clin Pract. 2013 Nov 19;8(1):19. doi: 10.1186/1940-0640-8-19.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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