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Treatment of Comorbid Depression and Substance Abuse in Young People

2015年6月24日 更新者:Dan Lubman

An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse

This study aims to treat young people with an adjunctive integrated cognitive behavioral therapy (CBT) intervention and to examine the acceptability of this treatment approach within this population. The study will also include a pilot placebo-controlled trial of sertraline for those young people who fail to or only partially respond to the CBT intervention, so as to determine whether adjunctive anti-depressant treatment improves clinical response in this population.

研究概览

详细说明

The high prevalence of co-occurring depressive and substance use disorders amongst young people is especially problematic given the significant negative impact on both symptom course and outcome reported in adult samples. Whilst the clinical and functional outcomes in young people with comorbid disorders remains largely unknown, of particular concern is the consistent association between depression, substance misuse and suicidality in young people, especially given the high rates of youth suicide in Australia. As such, it is both a clinical priority and an important public health goal that the clinical characteristics and outcomes of young people with comorbid depression and substance abuse are identified, and that effective biopsychosocial interventions are developed that encompass predictors of treatment, such that targeted integrated treatments may be offered wherever affected young people present.

Whilst there is strong evidence for both selective serotonin reuptake inhibitors (SSRIs) and CBT in the treatment of depression, and some support for their utility in alcohol dependence, no studies have examined their utility in a group of young people with comorbid depression and substance abuse. In fact, whilst CBT is suggested to be the first-line treatment for depression in young people, its role in comorbid disorders is less clear, and there is little data on predictors of treatment outcome in this population. Which young people best respond and which do not are important questions when designing the most appropriate interventions for real-world clinical settings. In this regard, the role of anti-depressants in comorbid populations also remains contentious, especially amongst those that fail or only partially respond to CBT. In particular, it is unclear at what stage anti-depressants should be offered or even whether SSRIs are indeed effective in this population.

Research Questions This project encompasses two complementary studies that aim to examine the characteristics and outcomes of young people with comorbid depression and substance abuse. Stage 1 is a preliminary naturalistic investigation of the characteristics of young people with comorbid depressive and substance use disorders presenting to drug treatment and mental health services, and describes their outcomes over 6, 12 and 24 months. This study seeks to explore what happens to these young people in the current service system, in terms of engagement and treatment, and related substance use and mental health outcomes. Stage 2 aims to treat a sub-sample of these young people with an adjunctive integrated CBT intervention and to examine the acceptability of this treatment approach within this population. In addition, this study seeks to explore predictors of treatment outcome so as to inform the further development of this integrated intervention. Stage 2 will also include a pilot placebo-controlled trial of sertraline for those young people who fail to or only partially respond to the CBT intervention, so as to determine whether adjunctive anti-depressant treatment improves clinical response in this population.

The specific aims of the study are:

  • To describe the course of depressive disorders amongst young people with comorbid substance use disorders
  • To explore predictors of treatment response to an integrated CBT intervention
  • To explore the acceptability of the CBT intervention within a comorbid youth population
  • To explore the role of sertraline in the treatment of non-response to CBT in a comorbid youth population

研究类型

介入性

注册 (实际的)

60

阶段

  • 阶段2

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

    • Victoria
      • Melbourne、Victoria、澳大利亚、3052
        • ORYGEN Youth Health

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

16年 至 26年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 16 and 26 years of age
  • acute major depressive episode (more than one month)
  • concurrent DSM-IV substance abuse/dependence or the use of any illicit drug on a weekly basis in the month prior to referral, or alcohol consumption exceeding NHMRC guidelines
  • English as their preferred language
  • estimated IQ >80

Exclusion Criteria:

  • Current or past history of psychosis
  • significant head injury
  • seizures
  • history or current evidence of any other significant clinical condition
  • treatment with an antidepressant within past 30 days

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:单组作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Sertaline
8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry
RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
其他名称:
  • 左洛复
An integrated 10-week CBT program for depression/anxiety and comorbid substance use
其他名称:
  • CBT
安慰剂比较:Placebo
8 week course of placebo
RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
其他名称:
  • 左洛复
An integrated 10-week CBT program for depression/anxiety and comorbid substance use
其他名称:
  • CBT

研究衡量的是什么?

主要结果指标

结果测量
大体时间
HAMD depression at 10 weeks, 20 weeks and 44 weeks
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
OTI TLFB substance use levels at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks

次要结果测量

结果测量
大体时间
MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
DAS self report dysfunctional attitudes at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
ATQ self report automatic thoughts at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
SDS self report severity of dependence at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
DUMM self report drug use motives at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
RTC self report readiness to change at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
CISS self report coping with stress at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
CGI severity of illness at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 weeks
SOFAS social and occupational functioning at same time points
大体时间:10 weeks, 20 weeks and 44 weeks
10 weeks, 20 weeks and 44 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

调查人员

  • 首席研究员:Dan Lubman、ORYGEN Youth Health, University of Melbourne, Department of Psychiatry

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

2004年9月1日

初级完成 (实际的)

2009年5月1日

研究完成 (实际的)

2009年5月1日

研究注册日期

首次提交

2005年10月2日

首先提交符合 QC 标准的

2005年10月2日

首次发布 (估计)

2005年10月4日

研究记录更新

最后更新发布 (估计)

2015年6月26日

上次提交的符合 QC 标准的更新

2015年6月24日

最后验证

2015年6月1日

更多信息

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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