Trial document




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  DRKS00005228

Trial Description

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Title

Aversive emotional tension of anorectic patients in daily course: A controlled and smartphone-based ambulatory monitoring

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Trial Acronym

SMART

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The dialectical behavior therapy (DBT) was originally designed for the treatment of patients with borderline personality disorder but now is used as well in the treatment of other disorders, e.g. eating disorders.
So far, the regulation of aversive emotional tension was never investigated neither in eating disorders nor in adolescents. Nor has been evaluated the possible benefit of the use of the patients' own smartphones in the clinical practice. The difference in the extent and course of the recorded emotional tension of female adolescents with anorexia nervosa in comparison to mentally healthy subjects of the same age shall be investigated.
Especially in adolescents, therapy compliance could be increased by the use of their own smartphones.
This case-control study is piloted for two groups of 20 female adolescents in the age of 12 to 19 years. In a period of two days the subjects will respond hourly to four questions in their smartphones. Additionally, they will fill in an online survey for socio-demographic data, a symptom checklist and an emotion regulation questionnaire before this period. Afterwards, they will participate in a usability questionnaire.

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Brief Summary in Scientific Language

Introduction:
In 2009 there was released the first german manual for therapy by emotion regulation for eating disorders (Schweiger & Sipos, 2009). There is also plenty of evidence in the clinical practice that patients with eating disorders can benefit of a skills training based on dialectical behaviour therapy.
Aversive emotional tension is a state that is perceived as negative which can be triggered by a stressor and is normally attended by high arousal.
It is yet well known that emotional tension is one of the main triggers for parasuicidal behavior in borderline personality disorder. Also there is a lot of evidence for a higher level of emotional tension in patients with other mental disorders, e.g. depression and anxiety disorders than in mentally healthy subjects. Patients normally report a high variability of the perceived emotional tension in the daily course and as well a reduction of the ability to recognize and to name perceived emotions during periods of high tension. It could also be investigated that the appliance of skills learned during a dialectical behavior therapy led to a reduction of the perceived emotional tension (Stiglmayr, 2005).

Objectives:
In this observant case-control study will be investigated for the first time if states of emotional tension in adolescent patients with anorexia nervosa are a relevant factor. Furthermore will be researched if these states underlie a specific daily course or daily variability, to what extent emotional tension inhibits the recognition and naming of emotions and if the actual occupation is related to emotional tension.
In addition, the usability of the used software will be evaluated in terms of its possible appliance in psychotherapy or future studies.

Methods:
For the investigation 20 female patients with anorexia nervosa and 20 mentally healthy female control subjects will be examined. Both groups will first participate in a pre-questionnaire (SCL-90R, FEEL-KJ) and afterwards in a 48-hours smartphone-based ambulatory monitoring with 4 questions on weekdays. Here the subjects will receive hourly a SMS (exceptions to previously arranged rest periods) which prompt to fill in the actual perceived value of emotional tension and the perceived emotion. For the monitoring the subjects will use their own smartphones. After the monitoring there will be a usability evaluation to measure how well the subjects got along with the used software.

Statistics:
Besides the descriptive statistics and explorative analysis, the difference of the mean perceived emotional tension will be primarily tested.

Sample Size Calculation: Emotional tension is scored between 0 and 100. We assume a clinical relevant difference with an effect size of 1 (SD=20, M1=60, M2=40) and calculate with 5% alpha error and 80% power to include in each group at least 16 cases.

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Organizational Data

  •   DRKS00005228
  •   2013/09/02
  •   [---]*
  •   yes
  •   Approved
  •   837.177.13, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  •   U1111-1147-3720 
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Health Condition or Problem studied

  •   F50.0 -  Anorexia nervosa
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Interventions/Observational Groups

  •   patient group: Female patients with F50.0 diagnosis will be questioned hourly for 2 days on their own smartphones about their experienced emotional tension.
  •   control group: Mentally healthy female control subjects will be questioned hourly for 2 days on their own smartphones about their experienced emotional tension.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

mean value of emotional tension (single values measured hourly in the ambulatory monitoring over 2 days)

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Secondary Outcome

Maximum value of emotional tension, course of emotional tension, emotion recognition rate (single values measured hourly in the ambulatory monitoring over 2 days), compliance (missing values).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/09/03
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   12   Years
  •   19   Years
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Additional Inclusion Criteria

informed consent of subject and parents

patient group: current diagnosis of an eating disorder F50.0

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Exclusion Criteria

patient group: (Presumed) diagnosis of an emotional instable personality disorder F60.31 (borderline) or F60.30 (impulsive).
control group: any diagnosis of a mental disorder in the last 5 years

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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 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Rheinhessen-Fachklinik MainzKinder- und Jugendpsychiatrie, -psychotherapie und –psychosomatik
    • Mr.  Dr. med.  Ekkehart  Jenetzky 
    • Hartmühlenweg 2-4
    • 55122  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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    • Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie der Universitätsmedizin Mainz
    • Mr.  Prof. Dr. med. Dipl. -Psych.  Michael  Huss 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/16
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* This entry means the parameter is not applicable or has not been set.