Trial document




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  DRKS00008946

Trial Description

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Title

A smartphone-enhanced low-threshold intervention for adolescents with Anorexia nervosa waiting for outpatient psychotherapy

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Trial Acronym

SELTIAN

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URL of the Trial

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Brief Summary in Lay Language

Waiting time until start of outpatient psychotherapy averages at 23.4 weeks in Germany (BPtK-Studie, 2011). Long waiting times increase the risk of more severe and prolonged courses of psychiatry disorders, especially for patients with Anorexia nervosa (AN; Zipfel, 2000). The ongoing and often serious weight loss of patients with AN during waiting times often results in then inevitable inpatient treatment.
Current clinical practice in the child and adolescent psychiatry are short consultations with weight measurement at a monthly basis until psychotherapy starts.
Smartphone applications could play a significant role in the support of patients with AN during waiting time. However, interventions with evidence-based smartphone applications are inexistent to this day (Juarascio et al., 2015).

Therefore, the aim of this study is to test an intervention using smartphone applications to provide mealtime protocols and self-help tools for weight stabilisation until the beginning of an outpatient psychotherapy.

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Brief Summary in Scientific Language

Patients with Anorexia nervosa (AN) wait on average 23.4 weeks until outpatient treatment in Rhineland-Palatinate, Germany (BPtK-Studie, 2011). Such long waiting times increase the risk for (another) inpatient treatment.
In this randomised-controlled study, a smartphone-based intervention bridging the waiting time until outpatient treatment for patients with AN is tested.
In a previous study, we already assessed aversive inner tension and emotional distress of patients with AN (Kolar, 2014). Patients with AN showed good acceptance rates of smartphone applications for daily protocolling (Kolar et al., 2015).

In the intervention group, patients will receive the "Jourvie Research" app for the systematical assessment of mealtimes and emotions. The protocols will be stored on central servers for the individual evaluation by the specific therapist. At the same time, emotion regulation strategies for reduction of aversive tension will be discussed by the patient with her therapist and can be included in the application. Within a 6-week training phase, biweekly consulations will be held for discussion of the protocols and weight management. Afterwards, consulations will be planned individually.
In the control group, biweekly consultations will be held in the first 6 weeks and on an individual basis afterwards.

Patients will be randomised on a 3:2 ratio to intervention or control group.

Primary endpoint is the weight difference between inclusion and 3-month follow up (higher weight or stabilisation in intervention vs. weight loss in control group), co-primary endpoint is reduction of aversive tension between inclusion and follow-up.

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Organizational Data

  •   DRKS00008946
  •   2015/12/16
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  •   yes
  •   Approved
  •   837.338.15 (10106), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  •   U1111-1172-4131 
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Health Condition or Problem studied

  •   F50.0 -  Anorexia nervosa
  •   F50.1 -  Atypical anorexia nervosa
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Interventions/Observational Groups

  •   Intervention group (smartphone app for protocolling meal times and emotions, and for the presentation of individual Emotion Regulation skills. 6 weeks biweekly 50-minute psychiatric consultations to discuss protocols and individual topics, afterwards on individual basis)
  •   control group (6 weeks biweekly 50-minute psychiatric consultations, afterwards on individual basis)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

BMI difference between inclusion and 3-month follow up (standardized for age and size)

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Secondary Outcome

reduction of aversive tension between inclusion and 3-month follow-up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/04/14
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   12   Years
  •   19   Years
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Additional Inclusion Criteria

- Established Diagnosis of Anorexia nervosa (F50.0 and F50.1)
- Informed consent of both patient and their respective legal guardians in case of being under age
- Android smartphone device, or willingness to use a device distributed by the medical centre

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Exclusion Criteria

- Co-morbid personality disorder of the emotionally-instable subtype
- Acute suicidality
- Ongoing inpatient treatment during participation (longer than one week)

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Addresses

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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie der Universitätsmedizin Mainz
    • Mr.  Prof. Dr.med. Dipl.-Psych.  Michael  Huss 
    • Langenbeckstr. 1
    • 55121  Mainz
    • Germany
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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie der Universitätsmedizin Mainz
    • Mr.  Dipl.-Psych.  David  Kolar 
    • Langenbeckstr.1
    • 55121  Mainz
    • Germany
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    • Rheinhessen-Fachklinik MainzKinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatik
    • Mr.  David  Kolar 
    • Hartmühlenweg 2-4
    • 55122  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Ressort Forschung und Lehre der Universitätsmedizin Mainz(intramural Research grant)
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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