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Treatment effectiveness of a mindfulness-based inpatient group psychotherapy in adolescent substance use disorder - study protocol for a randomized controlled trial.

Christiane Baldus, Laura Mokros, Anne Daubmann, Nicolas Arnaud, Martin Holtmann, Rainer Thomasius, Tanja Legenbauer

Trials December 27, 2018 DOI: 10.1186/s13063-018-3048-y (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Clinical protocol Randomized Peer reviewed
Sample size 340
Population Adolescents aged 13 to 19 years receiving child or adolescent psychiatric or psychotherapeutic inpatient or day treatment for substance use disorder, who reported substance use 30 days before detoxification and showed no acute psychotic or suicidal symptoms at baseline
Intervention Mindfulness-based group psychotherapy ("Mind it!")
Duration Assessments at baseline after detoxification (t0), 4 weeks (t1), 8 weeks (t2), and 6 months after t2 (t3)
Measures Timeline Followback
Topics Addiction Meditation
Keywords Humans Substance-related disorders Treatment outcome Prospective studies Feasibility studies Adolescent behavior Behavior, addictive Psychotherapy, group Time factors Germany Female Young adult Adolescents Group psychotherapy Mindfulness-based intervention
Key points The protocol proposes that adding mindfulness-based group psychotherapy ("Mind it!") to standard treatment may improve substance use outcomes for adolescents with substance use disorder, and aims to assess its added effect, feasibility, and possible mediators. No results are reported; the trial is planned to enroll 340 participants.

Abstract

Background: Current treatments for adolescents with substance use disorder (SUD) have had only limited success. In recent years, research has underlined the role of self-regulatory processes and impulsivity in the development and maintenance of SUD in adolescents. Mindfulness has gained much attention due to its capacity to influence self-regulatory processes, particularly in adult populations. Initial studies have shown the potential of mindfulness-based approaches in younger SUD patients. The aim of the present clinical trial is to evaluate the added treatment effect of a mindfulness-based group psychotherapy ("Mind it!") for adolescents with SUD in comparison to the current standard treatment. Moreover, we seek to explore the feasibility of the intervention and possible mediators of treatment effects. Methods/design: There will be N = 340 participants aged between 13 and 19 years who are receiving child or adolescent psychiatric or psychotherapeutic inpatient or day treatment targeting their SUD and who have reported substance use 30 days before detoxification and do not show acute psychotic or suicidal symptoms at baseline. The study is a prospective randomized controlled multi-center trial in which patients are assessed: (1) after completing a prior detoxification phase (t0), (2) at 4 weeks (t1), (3) at 8 weeks (t2), and (4) at 6 months after t2 (t3). Participants in the intervention group will receive mindfulness-based group psychotherapy in addition to their existing treatment regime. The primary outcome is substance use in the past 30 days at follow-up based on the Timeline Followback self-report. Secondary outcomes include craving, severity of dependence, and abstinence motivation. Mindfulness, impulsivity, and emotion regulation will be analyzed as possible mediators of treatment effects.

Discussion: This trial is expected to provide evidence of the added effect of a novel, safe, and feasible treatment option for adolescents with SUD.

Trial Registration: German Register of Clinical Studies, DRKS00014041 . Registered on 17 April 2018.

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