Treatment of Comorbid Depression and Substance Abuse in Young People

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Depression, Substance-Related Disorders

Intervention / Treatment
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* Drug: sertraline
* Behavioral: Cognitive Behavioural Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sertaline<br>8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry | Drug: sertraline<br>* RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry<br>* Other names: Zoloft;Behavioral: Cognitive Behavioural Therapy<br>* An integrated 10-week CBT program for depression/anxiety and comorbid substance use<br>* Other names: CBT;|
| Placebo Comparator: Placebo<br>8 week course of placebo | Drug: sertraline<br>* RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry<br>* Other names: Zoloft;Behavioral: Cognitive Behavioural Therapy<br>* An integrated 10-week CBT program for depression/anxiety and comorbid substance use<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD depression at 10 weeks, 20 weeks and 44 weeks |  | 10 weeks, 20 weeks and 44 weeks | 
| OTI TLFB substance use levels at same time points |  | 10 weeks, 20 weeks and 44 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks |  | 10 weeks, 20 weeks and 44 weeks | 
| DAS self report dysfunctional attitudes at same time points |  | 10 weeks, 20 weeks and 44 weeks | 
| ATQ self report automatic thoughts at same time points |  | 10 weeks, 20 weeks and 44 weeks | 
| SDS self report severity of dependence at same time points |  | 10 weeks, 20 weeks and 44 weeks | 
| DUMM self report drug use motives at same time points |  | 10 weeks, 20 weeks and 44 weeks | 
| RTC self report readiness to change at same time points |  | 10 weeks, 20 weeks and 44 weeks | 
| CISS self report coping with stress at same time points |  | 10 weeks, 20 weeks and 44 weeks | 
| CGI severity of illness at same time points |  | 10 weeks, 20 weeks and 44 weeks | 
| SOFAS social and occupational functioning at same time points |  | 10 weeks, 20 weeks and 44 weeks |