Trial document




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  DRKS00014647

Trial Description

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Title

Effectiveness of a smartphone intervention for self-support for depression. A randomized controlled trial.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This trial investigates the effects of a smartphone app for self-support for depression. We evaluate the effectiveness of a further developed smartphone application in a sample of individuals with heightened depressive symptomatology.

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Brief Summary in Scientific Language

The further developed smartphone application aiming at imparting self-supporting skills and with this reducing the depressive symptomatology.
We evaluate the effectiveness in a randomized controlled study.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014647
  •   2018/05/03
  •   [---]*
  •   yes
  •   Approved
  •   MB 042018_amd_072016, Deutsche Gesellschaft für Psychologie
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Secondary IDs

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Health Condition or Problem studied

  •   depressive symptomatology
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   The intervention group will play a gamified smartphone app utilizing techniques derived from cognitive bias modification and CBT for a period of 6 weeks. The users get to know one skill per day. This can take 10 to 30 minutes daily.

  •   The intervention group will play a gamified smartphone app utilizing techniques derived from cognitive bias modification and CBT for a period of 6 weeks. Additionally participants receive a text-based e-coaching (communication via chat within the application). The users get to know one skill per day. This can take 10 to 30 minutes daily.
  •   Wait list control condition
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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), Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

After 6 weeks: Depressiveness collected by means of PHQ-9 questionnaire using an online survey assessment

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Secondary Outcome

After 6 weeks: Impairment by depressive symptoms within the last week collected by means of ADS questionnaire using an online survey assessment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/05/10
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

PHQ-9 scores ≥ 10, access to a smartphone using Android 4.4 or above, sufficient German language skills, internet access, written confirmation of the declaration of consent

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Exclusion Criteria

Under 18 years of age, no access to a smartphone using Android 4.4 or above, PHQ-9 scores < 10, acute suicidality. If participants report acute suicidality, a separate contact follows aiming at clarifying whether a concrete suicide ideation exists. Only if this can be excluded a participation in the study is possible.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Friedrich-Alexander-University Erlangen-Nuremberg, Department of Clinical Psychology and Psychotherapy
    • Mr.  Prof. Dr.  Matthias  Berking 
    • Naegelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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    • Friedrich-Alexander-University Erlangen-Nuremberg, Department of Clinical Psychology and Psychotherapy
    • Mr.  Prof. Dr.  Matthias  Berking 
    • Naegelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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    • Friedrich-Alexander-University Erlangen-Nuremberg, Department of Clinical Psychology and Psychotherapy
    • Mr.  Prof. Dr.  Matthias  Berking 
    • Naegelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Friedrich-Alexander-University Erlangen-Nuremberg, Department of Clinical Psychology and Psychotherapy
    • Mr.  Prof. Dr.  Matthias  Berking 
    • Naegelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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