Trial document




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  DRKS00010705

Trial Description

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Title

ONLIFE- Smartphone use and diagnosis of depression

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Trial Acronym

ONLIFE

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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

We are initiating an explorative study with the aim of analysing possible correlations between different variables linked with smartphone-data, personality structure, physical activity and their association with symptoms and severity of depression. We would like to identify smartphone behaviours predicting diagnositic criteria of depression with the objective of early detection. In addition "ONLIFE" is a study with the aim of further investigating the psychopathology of chronic depression and the distinction to episodic depression regarding the construction of a new test for chronic depression.

We use various standardized questionnaires collected at two times of measurement (in the beginning of the study and 6 months later) and
gathering smartphonedata an their changes regarding depressiv symptoms over a period of 6 months to possibly identify behaviours predicting diagnostic cirteria of depression.
Therefore, 200 depressive patients aged between 18 and 60 from the Department of Psychiatry and Psychotherapy at the Ludwig-Maximilians-Universität, Munich , and 200 healthy control subjects be involved.

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Organizational Data

  •   DRKS00010705
  •   2016/09/01
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  •   yes
  •   Approved
  •   310-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
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Interventions/Observational Groups

  •   Patients (N=200; N = 100 patients with episodic depression and N=100 patients with chronic depression)

    Measuring depression-specific symptoms (IDCL, BDI-II), personality variables (NEO-FFI), Instruments covering fear, anger, emotionregulation (DERS, STAI, STAXI), resilience (CD-Risc), trauma (CTQ), social networking (SNI), smartphone addiction (SAS-SV)

    All of this standardized questionnaires will be measured at two times of measurement (at baseline and 6 months later)

    Gathering Smartphonedata an their changes regarding depressiv symptoms for 6 Months (GPS, Phoneuse, Calls, SMS/Mails, Apps and Appuse, vibration / mute, Notifications, calendar items, reminders, WLAN On/Off, flightmode on/off, music, frequency of taking pictures and videos, Bluetooth).
  •   Control subjects (N=200)

    Measuring depression-specific symptoms (IDCL, BDI-II), personality variables (NEO-FFI), Instruments covering fear, anger, emotionregulation (DERS, STAI, STAXI), resilience (CD-Risc), trauma (CTQ), social networking (SNI), smartphone addiction (SAS-SV)

    All of this standardized questionnaires will be measured at two times of measurement (at baseline and 6 months later)

    Gathering Smartphonedata an their changes regarding depressiv symptoms for 6 Months (GPS, Phoneuse, Calls, SMS/Mails, Apps and Appuse, vibration / mute, Notifications, calendar items, reminders, WLAN On/Off, flightmode on/off, music, frequency of taking pictures and videos, Bluetooth).
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

-Measuring depression-specific symptoms (IDCL, BDI-II), personality variables (NEO-FFI), Instruments covering fear, anger, emotionregulation (DERS, STAI, STAXI), resilience (CD-Risc), trauma (CTQ), social networking (SNI), smartphone addiction (SAS-SV)

All of this standardized questionnaires will be measured at two times of measurement (at baseline and 6 months later)

- Gathering Smartphonedata an their changes regarding depressiv symptoms for 6 Months (GPS, Phoneuse, Calls, SMS/Mails, Apps and Appuse, vibration / mute, Notifications, calendar items, reminders, WLAN On/Off, flightmode on/off, music, frequency of taking pictures and videos, Bluetooth).

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Secondary Outcome

Differences in covered data regarding chronic / episodic depressive patients and construction of a new test for chronic depression.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/11/01
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Patients: Diagnosis of Depression (F32.x, F33.x, F34.1), ambulant/stationary psychotherapeutic/psychiatric treatment

Control subjects: Physical and mental healthy subjects without mental diseases in their ananmnesis.

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Exclusion Criteria

Patients: acute suicidal tendency, substance addiction, pregnancy, serious physical/somatic diseases, psychotic disorders, bipolar disorder, insufficient german language skills; Primary Diagnosis: panic disorder, GAD, social phobia, PTSD

Control subjects: intake of psychiatric medication, serious physical diseases, pregnancy, psychiatric diagnosis

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Addresses

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    • Leiter der Sektion Psychosomatische Medizin und PsychotherapieKlinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München
    • Mr.  Prof. Dr.  Frank  Padberg 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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    • Ludwig-Maximilians-Universität MünchenDepartment PsychologieLehrstuhlinhaber psychologische Methodenlehre und Diagnostik
    • Mr.  Prof. Dr.  Markus  Bühner 
    • Leopoldstr. 13
    • 80802  München
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München Sektion Psychosomatische Medizin und Psychotherapie
    • Ms.  Dipl.-Psych.  Katja  Alrich 
    • Nußbaumstr. 7
    • 803336  München
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU MünchenSektion Psychosomatische Medizin und Psychotherapie
    • Ms.  Dipl.-Psych.  Katja  Alrich 
    • Nußbaumstr. 7
    • 803336  München
    • Germany
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Sources of Monetary or Material Support

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    • Leiter der Sektion Psychosomatische Medizin und Psychotherapie Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München
    • Mr.  Prof. Dr.  Frank  Padberg 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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    • Ludwig-Maximilians-Universität MünchenDepartment PsychologieLehrstuhlinhaber psychologische Methodenlehre und Diagnostik
    • Mr.  Prof. Dr.  Markus  Bühner 
    • Leopoldstr. 13
    • 80802  München
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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