Trial document

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DRKS-ID: 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

DRKS-ID: DRKS00010705
Date of Registration in DRKS: 2016/09/01
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

ICD10: F32 - Depressive episode
ICD10: F33 - Recurrent depressive disorder
ICD10: F34.1 - Dysthymia

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Interventions/Observational Groups

Arm 1: 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).
Arm 2: 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

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Non-randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Other
Purpose: Prevention
Assignment: Other
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

University Medical Center Klinik und Poliklinik für Psychiatrie und Psychotherapie der LMU München, München

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2016/11/01
Target Sample Size: 400
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Primary Sponsor
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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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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- Telephone: 0176/70882870
- Fax: [---]*
- E-mail: katja.alrich at med.uni-muenchen.de
- URL: [---]*
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Contact for Public Queries
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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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- Telephone: 0176/70882870
- Fax: [---]*
- E-mail: katja.alrich at med.uni-muenchen.de
- URL: [---]*
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Institutional budget, no external funding (budget of sponsor/PI)
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting planned
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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