RecruitingPhase 4ACTRN12605000675628

Treatment of Comorbid Depression and Substance Abuse in Young People

A cross-over study to evaluate the effects of a cognitive behavioural therapy (CBT) intervention, followed by a randomised trial of sertraline/placebo (for non-responders to CBT only) in the treatment of comorbid depression and substance misuse to improve outcome in depression and substance use levels.


Sponsor

Melbourne Health

Enrollment

50 participants

Start Date

Jan 1, 2005

Study Type

Interventional

Conditions

Summary

This study 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. 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 relationship between genetic variants of the 5-HTT and treatment response to both the CBT arm and SSRI treatment will also be explored.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 26 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for young people who are dealing with both depression and drug or alcohol problems at the same time. It tests whether a talking therapy called CBT (Cognitive Behavioural Therapy), specifically designed for both issues together, can help reduce depression and substance use. For those who do not fully respond to CBT, there is also a pilot trial of an antidepressant medicine called sertraline. You may be eligible if: - You are between 16 and 26 years old - You are currently experiencing a major depressive episode (lasting more than one month) - You also have a substance use problem — either a diagnosis of abuse or dependence, or you use any illegal drug at least weekly, or you drink more alcohol than the NHMRC guidelines recommend - English is your preferred language - Your estimated IQ is above 80 You may NOT be eligible if: - You have a current or past history of psychosis, significant head injury, seizures, neurological disease, thyroid problems, or are taking steroids - You are participating in any other study or have been in one in the past 30 days - You have taken an antidepressant in the past 30 days - You are pregnant or breastfeeding, or are a woman of childbearing age not using an accepted form of contraception Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study is a naturalistic, prospective study of a targeted two-stage intervention, comprising a 10-session Cognitive Behaviour Therapy (CBT) intervention and a randomised 10-week double-blind, plac

This study is a naturalistic, prospective study of a targeted two-stage intervention, comprising a 10-session Cognitive Behaviour Therapy (CBT) intervention and a randomised 10-week double-blind, placebo-controlled trial of sertraline for partial and non-responders to the CBT intervention at week 6.


Locations(1)

Australia

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ACTRN12605000675628