Trial document




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  DRKS00021588

Trial Description

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Title

Naturalistic evaluation of an Internet-based psychological training program for mental strain associated with the coronavirus / COVID-19 pandemic

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Trial Acronym

HelloBetter Corona

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URL of the Trial

https://www.hellobetter.de/corona

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Brief Summary in Lay Language

The ongoing COVID-19 pandemic is associated with a wide range of stressors for the general population. Evidence to date points to the urgent need for low-threshold psychological training formats to meet the increased need for psychological support and to prevent negative effects on the mental health of the general population. The research project will use routine data to investigate whether an Internet-based intervention for coping with strain associated with the "corona crisis" can improve the mental well-being of participants, and whether this form of intervention is well accepted.

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Brief Summary in Scientific Language

In a pragmatic study, data of max. N=1000 persons who partake in a free Internet-based intervention format as part of the initiative "Stark durch die Krise" (www.starkdurchdiekrise.de) are examined. The intervention is based on the Internet-based format "GET.ON Fit im Stress". The intervention concept examined in the study project was adapted in part to take current stressors caused by the COVID-19 pandemic into account. In accordance with scalable universal prevention concepts, the Intervention is implemented without direct personal feedback. However, it is possible to use a support address and a free, companion "corona hotline" to establish personal contact with trained psychologists. Due to the universal, low-threshold intervention approach, only "treatment starters", who have completed at least the first session of the training, will be considered for the primary effectiveness evaluation.

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

Yes

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Description IPD sharing plan:

Data on depressive symptoms, anxiety symptoms and perceived stress (baseline, 2-weekly interim assessments, post) examined in the effectiveness analysis can be passed on anonymously on request after completion of the primary data analysis.

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Organizational Data

  •   DRKS00021588
  •   2020/05/04
  •   [---]*
  •   yes
  •   Approved
  •   172_20 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F43.2 -  Adjustment disorders
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Interventions/Observational Groups

  •   Online training "HelloBetter Corona", consisting of 8 weekly sessions. Each session will be completed in approximately 45-60 minutes. Contents of the online training refer to problem- and emotion-focused coping for potentially solvable or unsolvable stressors. Concepts and contents are based on the intervention "Get.On Fit im Stress". Contents were adapted to the special conditions and stressors in the context of the "Corona crisis".
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Depressive Symptoms, Patient Health Questionnaire 8-item version (PHQ-8; Kroenke, Spitzer, Williams, 2001), Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks (Post-assessment)

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Secondary Outcome

- Anxiety, Generalized Anxiety Disorder 7 (GAD-7; Spitzer et al., 2006), Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks (Post-assessment)
- Perceived Stress, Perceived Stress Scale (PSS-4; Cohen, 1983), Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks (Post-assessment)
- Mood Rating (Visual Analog Scale 0-10), daily, optional
- Stress Rating (Visual Analog Scale 0-10), daily, optional
- Demographic Assessments (Age, Sex)
- Intervention Satisfaction (Usefulness, Complexity, Recommendation), after each session, optional

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/05/08
  •   1000
  •   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

Internet Access, E-Mail Address

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Exclusion Criteria

Dissociative symptoms currently or in the past, suicidality, no informed consent

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Addresses

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    • Universität Erlangen-Nürnberg, Institut für Psychologie, Lehrstuhl für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr.  Matthias  Berking 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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    • Universität Erlangen-Nürnberg, Institut für Psychologie, Lehrstuhl für Klinische Psychologie und Psychotherapie
    • Mr.  M.Sc.  Mathias  Harrer 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie, Friedrich-Alexander-Universität Erlangen-Nürnberg
    • Mr.  M.Sc.  Mathias  Harrer 
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Lehrstuhl für Klinische Psychologie, Institut für Psychologie
    • Mr.  Prof. Dr.  Matthias  Berking 
    • Nägelsbachstraße 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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* This entry means the parameter is not applicable or has not been set.