Depression Clinical Trial
Official title:
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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