Trial document



drksid header

  DRKS00010705

Trial Description

start of 1:1-Block title

Title

ONLIFE- Smartphone use and diagnosis of depression

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ONLIFE

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010705
  •   2016/09/01
  •   [---]*
  •   yes
  •   Approved
  •   310-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
end of 1:N-Block indications
start of 1:N-Block interventions

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).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2016/11/01
  •   400
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • 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
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address primary-sponsor
    • Ludwig-Maximilians-Universität MünchenDepartment PsychologieLehrstuhlinhaber psychologische Methodenlehre und Diagnostik
    • Mr.  Prof. Dr.  Markus  Bühner 
    • Leopoldstr. 13
    • 80802  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • 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
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU MünchenSektion Psychosomatische Medizin und Psychotherapie
    • Ms.  Dipl.-Psych.  Katja  Alrich 
    • Nußbaumstr. 7
    • 803336  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • 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
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address materialSupport
    • Ludwig-Maximilians-Universität MünchenDepartment PsychologieLehrstuhlinhaber psychologische Methodenlehre und Diagnostik
    • Mr.  Prof. Dr.  Markus  Bühner 
    • Leopoldstr. 13
    • 80802  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.