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

2013年9月9日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

86

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 澳大利亚
    • New South Wales
      • Sydney、New South Wales、澳大利亚、2050
        • Drug Health Services, Royal Prince Alfred Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：日常护理
行为的：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.
实验性的：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.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Alcohol consumption
大体时间：12 weeks
Time to relapse (>5 drinks on any one day)
12 weeks
Time to lapse
大体时间：12 weeks
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
12 weeks
amount of alcohol consumption
大体时间：12 weeks
expressed as the average consumption per drinking day
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Improvement in depressive or anxiety symptoms
大体时间：12 weeks
DASS 21
12 weeks
Diagnosis severity
大体时间：16 weeks
clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.
16 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

South West Sydney Local Health District

合作者

University of Sydney

调查人员

  • 首席研究员：Andrew Baillie、Macquarie University
  • 首席研究员：Paul Haber、University of Sydney

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年3月1日

初级完成 (实际的)

2010年12月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2013年9月5日

首先提交符合 QC 标准的

2013年9月9日

首次发布 (估计)

2013年9月13日

研究记录更新

最后更新发布 (估计)

2013年9月13日

上次提交的符合 QC 标准的更新

2013年9月9日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • X05-0279

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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赞助者/合作者

地点

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