Treatment of Comorbid Depression and Substance Abuse in Young People

June 24, 2015 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • ORYGEN Youth Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dan Lubman

Investigators

  • Principal Investigator: Dan Lubman, ORYGEN Youth Health, University of Melbourne, Department of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 2, 2005

First Submitted That Met QC Criteria

October 2, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHREC 2004.030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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