Trial document




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  DRKS00014043

Trial Description

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Title

Motivational Interviewing as a tool to enhance access to mental health treatment in adolescents with chronic medical conditions and need for psychological support (COACH-MI)

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Trial Acronym

COACH-MI

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

BACKGROUND
This cluster-randomized, monocentric controlled trial focuses on the improvement of mental healthcare uptake of adolescents with chronic medical conditions who were identified by screening for depression and/or anxiety. The study aims to determine the effectiveness of Motivational Interviewing (MI) delivered by trained physicians to increase 12- to 20-year-old adolescents’ utilization of psychological healthcare for symptoms of anxiety and depression.
METHODS/DESIGN
By means of a single-centre approach, n = 1,000 adolescents will be screened (PHQ-9; GAD-7), and adolescents with results indicative for anxiety or depression symptoms (about n = 160) will be advised to seek psychological healthcare. Participants with a positive screening will receive either two sessions of MI or treatment as usual (TAU, regarded as the typical daily clinical routine) with focus on the recommendation to visit psychological healthcare for further evaluation.
MI effectiveness will be compared to current TAU as control condition. Primary outcome is the utilization rate of psychological healthcare after counselling a MI-trained physician vs. a not-trained physician. Additionally, reasons for not claiming psychological support and changes in disease-related parameters will be evaluated in a 6-months follow-up.
DISCUSSION
This trial will evaluate the feasibility of MI as a means to improve service utilization of mental healthcare for adolescents who need further support other than that provided in standard care for chronic diseases. Implementing MI by the treating physician for adolescents might serve as a model for optimizing healthcare management in daily clinical routines, which could improve adolescents’ long-term perspectives by preventing treatment loss and negative long-term consequences into adulthood.

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Organizational Data

  •   DRKS00014043
  •   2018/04/26
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  •   yes
  •   Approved
  •   6244R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   E10-E14 -  Diabetes mellitus
  •   G40 -  Epilepsy
  •   E84 -  Cystic fibrosis
  •   F32 -  Depressive episode
  •   F41 -  Other anxiety disorders
  •   E88 -  Other metabolic disorders
  •   I00-I99 -  Diseases of the circulatory system
  •   cystic fibrosis
  •   Endocrinological diseases
  •   rheumatological disorders
  •   gastroenterological diseases
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Interventions/Observational Groups

  •   Patients with positive screening, who get "motivational interviewing"
  •   Patients with positive screening, who get "standard care" treatment
  •   Patients with negative screening
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is the utilization rate of psychological healthcare within six months after counselling a physician trained in "motivational interviewing" vs. a not-trained physician.

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Secondary Outcome

Secondary outcomes are improvement of symptoms of anxiety and depression and treatment related parameters in the 6-months follow-up. Furthermore, the success of a short "motivational interviewing" education of physicians for our setting will be analysed by evaluation of the interviews. The screening results for anxiety and depression over a broad spectrum of chronic disease will be descriptively analysed.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/27
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   20   Years
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Additional Inclusion Criteria

Adolescents with chronic medical conditions will be eligible for mental health screening if they are between 12 and 20 years of age. Chronic medical conditions are defined as diseases with one or more of the following characteristics: condition duration > 1 year, which significantly impairs their daily routine and requires continuous care and/or medical treatment.

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Exclusion Criteria

Participants will be excluded in cases of current regular psychotherapy utilization before the recruitment, psychosis, acute suicidality, severe intellectual disability (IQ < 70), inability to communicate (verbally or in writing) or current substance abuse (alcohol, drugs).

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Addresses

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    • Universitätsklinikum Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Professor  Thomas  Meissner 
    • Moorenstraße 5
    • 40233  Düsseldorf
    • Germany
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    • Universitätsklinikum DüsseldorfKlinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Professor  Thomas  Meissner 
    • Moorenstraße 5
    • 40233  Düsseldorf
    • Germany
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    • Universitätsklinikum DüsseldorfKlinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Professor  Thomas  Meissner 
    • Moorenstraße 5
    • 40233  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.