Trial document




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  DRKS00014041

Trial Description

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Title

Treatment of mindfulness-based psychotherapy in adolescent inpatients with substance use disorders

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Trial Acronym

IMAC-Mind it

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URL of the Trial

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Brief Summary in Lay Language

This study is concerned with the development and evaluation of a mindfulness-based therapy manual for adolescents (13 to 19 years) with substance use disorders, who completed the stationary withdrawal. The training will be implemented in the stationary setting for 8 weeks. Data will be collected from the adolescents before training starts, 4 and 8 weeks after training start and 6 months after treatment completion. Therefor, different questionnaires and an interview will be used. The aim of the study is to clarify whether a mindfulness-based therapy manual for addicted adolescent inpatients could be implemented in the stationary setting meaningfully and whether this additional treatment would be more effective or leads to less drug use after stationary discharge.

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Brief Summary in Scientific Language

This study is concerned with the development and Evaluation of a mindfulness-based therapy Manual for adolescents (13 to 19 years) with substance use disorders, who completed the stationary withdrawal. The Training will be implemented in the stationary Setting for 8 weeks. Data will be collected from the adolescents before training starts, 4 and 8 weeks after training start and 6 months after treatment completion. Therefor, different questionnaires and an interview will be used. The aim of the study is to clarify whether a mindfulness-based therapy Manual for addicted adolescent inpatients could be implemented in the stationary Setting meaningfully and whether this additive treatment would be more effective or leads to better rates of abstinence after stationary discharge.

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Organizational Data

  •   DRKS00014041
  •   2018/04/17
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  •   yes
  •   Approved
  •   17-6268, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F12.2 -  Mental and behavioural disorders due to use of cannabinoids; Dependence syndrome
  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   Patients in the experimental group receive 12 group therapy sessions of a mindfulness-based therapy manual à 45 minutes in 8 weeks in addition to the stationary treatment as usual (TAU).
    The mindfulness-based group intervention integrates both formal mindfulness-meditation practices as known from MBCT (mindfulness based cognitive therapy) such as bodyscan meditation, mindfulness of the breath meditation, mindfulness of the body in movement and sitting meditation, and informal mindfulness practice, which supports participants to integrate mindful awareness in their daily routines. Inquiry is used as a group technique to reflect on experiences during meditation and psychoeducation elements are used to teach participants about substance use, stress, stress reactivity, craving, the development of coping skills and a rationale on why mindfulness helps with substance use problems. Each session includes formal mindfulness meditation practices and participants are encouraged to establish mindfulness practice outside group sessions.
    The standard SUD treatment consists of a structured, multidimensional concept consisting of two treatment phases: (1) In a first detoxification phase of treatment, a protected environment guarantees safe detoxification and constant monitoring of possible withdrawal symptoms. Within that setting, detailed psychiatric, neuropsychological and psychosocial diagnostics are performed. First psycho-education elements are used to address patients’ SUD problem background. Moreover, patients are motivated to continue treatment after this first detoxification phase. (2) Treatment after the detoxification phase addresses comorbid problems and disorders as the background of patients’ SUD. Psycho-educational interventions are used to motivate patients to abstain from substance use in their future life, necessary skills are developed and measures against relapse are taken. The SUD treatment concept integrates psychotherapeutic, somatic and medical interventions, family therapy, occupational therapy and music therapy. These treatment elements are delivered in single or group sessions.
  •   Patients in the control group receive the stationary treatment as usual (TAU).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

The primary outcome of the study is the number of days with substance use (alcohol, psychoactive substances and/or illicit drugs) in the last 30 days 6 months after completion of the mindfulness-based therapy tool. Drug use will be determined by the timelife-followback-interview (TLFB).

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Secondary Outcome

Time points of assessment:
- t0: Before treatment start
- t1: 4 weeks after treatment start
- t2: 8 weeks after treatment start
- t3: 6 months after treatment completion

- Craving will be assessed by the CCS-7 [Inventory for an assessment of cannabis craving] (Schnell et al., 2011) in t0, t1, t2, t3
- Subjective experienced changes in well-being/health related life quality assessed by the KIDSCREEN-10 [Erfassung der gesundheitsbezogenen Lebensqualität von Kindern und Jugendlichen mittels Selbstauskunft und Fremdurteil] (Ravens-Sieberer et al., 2008) in t0, t2, t3
- Abstinence motivation (Körkel & Schindler, 2004) in t0, t2, t3
- Degree of substance addiction by the SDS [Severity of Dependence Scale] (Gossop et al., 1995) in t0, t2, t3
- Mindfulness-skills will be assessed with the MTASA [Mindful thinking and action scale for adolescents] (West et al., 2005) in t0, t1, t2, t3
- Impulsivity with the UPPS-scale [Impulsive behavior scale] (Kämpfe & Mitte, 2009) in t0, t2, t3
- Perceived stress with the PSS-4 [Perceived stress scale] (Klein et al., 2016) in t0, t1, t2, t3
- Number of disability days in school/work in t0, t3
- Comorbid diagnoses with the DISYPS checklists [Diagnostik-System für psychische Störungen nach ICD-10 und DSM-V für Kinder und Jugendliche] for ADHD, CD, depression, anxiety und trauma (Döpfner & Görtz-Dorten, 2017) in t0
- General level of psychosocial functioning with the GAF [Globale Beurteilung des psychosozialen Funktionsniveaus] of the ICD-10 (Remschmidt & Schmidt, 2009) in t0, t3
- Changes in medication intermittently
- Adherence of the applied interventions to MBRP concepts (Chawla et al., 2010), competence of the therapists (Kohrt et al., 2015) and feasibility of the elaborated manual (Bird et al., 2014), intermittently
- Treatment acceptance of the patients (participation in the group sessions, homework implementation, exercises), intermittently
- Recording of all treatment modules included in TAU, intermittently
- Recording of adverse events (AEs), intermittently

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/08/16
  •   246
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   13   Years
  •   19   Years
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Additional Inclusion Criteria

Adolescents with substance use disorders, who completed the stationary withdrawal and want an additional stationary therapy.

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Exclusion Criteria

- Acute suicidality
- Schizophrenia, acute psychotic symptoms
- IQ below 70
- Unsatisfactory knowledge of the German language of the patient or his/her parents

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Addresses

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    • Ruhr-Universität Bochum
    • Universitätsstraße 150
    • 44801   Bochum
    • Germany
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    • UKE Hamburg
    • Ms.  Dr.  Christiane  Baldus 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • LWL Universitätsklinik Hamm
    • Ms.  Prof. Dr.  Tanja  Legenbauer 
    • Heithofer Allee 64
    • 59071  Hamm
    • Germany
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    • LWL Universitätsklinik Hamm
    • Ms.  Dr.  Laura  Mokros 
    • Heithofer Allee 64
    • 59071  Hamm
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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