Treatment of Comorbid Depression and Substance Abuse in Young People

NCT ID: NCT00232284

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-05-31

Brief 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

Conditions

Depression; Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sertaline

8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry

Group Type: ACTIVE_COMPARATOR

sertraline

Intervention Type: DRUG

RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

An integrated 10-week CBT program for depression/anxiety and comorbid substance use

Placebo

8 week course of placebo

Group Type: PLACEBO_COMPARATOR

sertraline

Intervention Type: DRUG

RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

An integrated 10-week CBT program for depression/anxiety and comorbid substance use

Interventions

sertraline

RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry

Intervention Type: DRUG

Cognitive Behavioural Therapy

An integrated 10-week CBT program for depression/anxiety and comorbid substance use

Intervention Type: BEHAVIORAL

Other Intervention Names

Zoloft; CBT

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dan Lubman

OTHER

Sponsor Role: lead

Responsible Party

Dan Lubman

Dr Dan Lubman

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dan Lubman

Role: PRINCIPAL_INVESTIGATOR

ORYGEN Youth Health, University of Melbourne, Department of Psychiatry

Locations

ORYGEN Youth Health

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

MHREC 2004.030

Identifier Type: -

Identifier Source: org_study_id