Treatment of Comorbid Depression and Substance Abuse in Young People
Condition: Depression; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): sertraline; Cognitive Behavioural Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry; An integrated 10-week CBT program for depression/anxiety and comorbid substance use
Other intervention name(s): Zoloft; CBT
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment