Trial document




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  DRKS00021153

Trial Description

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Title

get.calm and move.on – tackling worries and finding strength for the crisis (COVID-19) in 10 steps

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Trial Acronym

get.calm_move.on

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URL of the Trial

https://geton-training.de/get-calm-and-move-on

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Brief Summary in Lay Language

The Corona crisis is characterized by the concern about getting infected with the virus, the concern about the health of the people close to us and many unanswered questions about how everything will develop in the near future. Perhaps the job and the financial situation have become uncertain. All this can cause worry and anxiety. Worries can sometimes become so intense that people feel paralyzed and lose courage to take the next step. If the worries are getting too strong, then it is important to calm down a bit. If the problems seem too big, then it can be important to gain confidence for the next step.
With this in mind, an online training programme has been developed to help you cope with worries: get.calm and move.on - tackle worries in 10 steps and gain strength for the corona crisis.
Every day a training unit is available in which one aspect of worries is taken into account. The training can be completed in 10 days. The contents of the training refer to reflecting on what is really important to you, to consciously address some worries and to be able to distance yourself from others, to tackle some problems step by step and to learn from others to accept and endure them. It is also explained that it is important to be able to perceive and appreciate even small pleasant experiences, to use relaxation exercises, to ensure a good night's sleep and to structure the day well.
The study serves to check the effectiveness of the training.

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Brief Summary in Scientific Language

The physical consequences of an infection with the corona virus (COVID-19) are known. In addition to the direct biological consequences, fears of infection and social distancing, including an ordered quarantine, represent a considerable psychological burden. The available studies show that virus epidemics and the resulting isolation or quarantine are associated with fear of infection, depression, low spirits, post-traumatic and general stress symptoms, irritability and anger (Brooks, Webster, Smith, Woodland, Wessely, Greenberg & Rubin, 2020). Adverse effects on mental health were found up to 3 years after the crisis. During this period, longer periods of quarantine, frustration, boredom, inadequate health care, insufficient information, financial losses and fear of stigmatization had a reinforcing effect on the unfavorable effects.

The aim of the present study is to evaluate an intervention for people from the general population (universal preventive approach) to provide support for coping with worries in the corona crisis.

In a 2-arm randomized controlled trial, (P) people from the general population who participate in the (I) self-help online training "get.calm and move.on” will be compared to (C) a waiting control group with access to the recommendations of the German Association for Psychiatry, Psychotherapy and Psychosomatics on coping with the corona crisis (O) with regard to the reduction of worries.

The online training is a newly developed intervention. It contains individual modules from various interventions for stress management [Heber E, Lehr D, Ebert DD et al (2016) Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial. Journal of Medical Internet Research 18:e21], for dealing with negative thoughts [Thiart H, Lehr D, Ebert DD et al (2015) Log in and breathe out: internet-based recovery training for sleepless employees with work-related strain - results of a randomized controlled trial. Scandinavian Journal of Work, Environment & Health 41:164-74], on building resources [Heckendorf, H., Lehr, D., Ebert, D. D., & Freund, H. (2019). Efficacy of an internet and app-based gratitude intervention in reducing repetitive negative thinking and mechanisms of change in the intervention's effect on anxiety and depression: Results from a randomized controlled trial. Behaviour Research and Therapy, 119, 103415] and on value-based behaviour activation [Michalak, Hofheim & Heidenreich (2017). Value-based behaviour activation in depressive disorders, Beltz, Weinheim Basel].

Recommendations of the German Association for Psychiatry, Psychotherapy and Psychosomatics on coping with the corona crisis: https://www.dgppn.de/schwerpunkte/corona-psyche.html

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021153
  •   2020/04/06
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  •   yes
  •   Approved
  •   EB-Antrag_202003_12_Lehrgetcalm, Leuphana Universität, Ethikbeirat der Leuphana Universität Lüneburg, Geschäftsstelle Ethikbeirat Universitätsallee 1, C10.205 21335 Lüneburg Fon 04131.677-1692 Fax 04131.677-1575 ethikbeirat@leuphana.de https://www.leuphana.de/forschung/transparenz-in-der-forschung/ethikbeirat.html
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Secondary IDs

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Health Condition or Problem studied

  •   Worry
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Interventions/Observational Groups

  •   Interventiongroup, direct access to the internet intervention
  •   Waitlist controlgroup, delayed access to the internet intervention
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Worry: Penn State Worry Questionnaire: Meyer, T. J., Miller, M. L., Metzger, R. L. & Borkovec, T. D. (1990). Development and validation of the Penn State Worry Questionnaire. Behaviour Research and Therapy, 28, 487-495. (t1, t2, t3, t4)

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Secondary Outcome

• Fear of infection. Items based on: Bai Y, Lin C-C, Lin C-Y, Chen J-Y, Chue C-M, Chou P. Survey of stress reactions among health care workers involved with the SARS outbreak. Psychiatr Serv 2004; 55: 1055–57. (t1, t2, t3, t4)

• Depression: Patient Health Questionaire (PHQ-8): Kroenke, K., Strine, T. W., Spitzer, R. L., Williams, J. B. W., Berry, J. T., & Mokdad, A. H. (2009). The PHQ-8 as a measure of current depression in the general population. Journal of Affective Disorders, 114(1–3), 163–173. (t1, t2, t3, t4)

• Worry / Generalized anxiety (GAD-7); Löwe B, Decker O, Müller S, Brähler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. 163–173. (t1, t2, t3, t4)

• Emotion regulation skils . Berking, M. & Znoj, H. (2008). Entwicklung und Validierung eines Fragebogens zur standardisierten Selbsteinschätzung emotionaler Kompetenzen (SEK-27). Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 56(2), 141-152. (t1, t2, t3, t4)

• Brief Resilience Scale. Chmitorz A, Wenzel M, Stieglitz R-D, Kunzler A, Bagusat C, Helmreich I, et al. (2018) Population-based validation of a German version of the Brief Resilience Scale. PLoS ONE 13(2): e0192761 (t1, t2, t3, t4)

• General self-efficacy. Beierlein, C., Kovaleva, A., Kemper, C. J. & Rammstedt, B. (2012). Ein Messinstrument zur Erfassung subjektiver Kompetenzerwartungen. Allgemeine Selbstwirksamkeit Kurzskala (ASKU) (Working Papers 2012|17). Mannheim: GESIS - Leibniz-Institut für Sozialwissenschaften. (t1, t2, t3, t4)

• Personal Growth - short form. Maercker, A., & Langner, R. (2001). Persönliche Reifung (personal growth) durch Belastungen und Traumata: Validierung zweier deutschsprachiger Fragebogenversionen. Diagnostica, 47(3), 153–162. (t2, t3, t4)

• WHO-5 Well-Being. Brähler E, Mühlan H, Albani C, Schmidt S. Teststatistische Prüfung und Normierung der deutschen Versionen des EUROHIS-QOL Lebensqualität-Index und des WHO-5 Wohlbefindens-Index. Diagnostica. 2007; 53(2):83-96. (t1, t2, t3, t4)

Additional variables:
• Demografics (t1)
• Status of infection (t1, t2, t3, t4)
• Duration and reasons for self isolation or quarantine (t1, t2, t3, t4)
• Reasons for dropout (t2).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/04/07
  •   352
  •   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

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Exclusion Criteria

- diagnosed psychosis or dissociative symptoms in the past
- Increased risk of suicide (BDI-II value for question 9>1)

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Addresses

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    • Leuphana Universität Professur für Gesundheitspsychologie und Angewandte Biologische PsychologieInstitut für Psychologie
    • Mr.  Prof. Dr.  Dirk  Lehr 
    • Universitätsallee 1
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Professur für Gesundheitspsychologie und Angewandte Biologische PsychologieInstitut für Psychologie
    • Mr.  Prof. Dr.  Dirk  Lehr 
    • Universitätsallee 1
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg
    • Ms.  Hanna  Heckendorf 
    • Universitätsallee 1
    • 21335  Lüneburg
    • Germany
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Sources of Monetary or Material Support

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    • Leuphana Universität Professur für Gesundheitspsychologie und Angewandte Biologische Psychologie Institut für Psychologie
    • Universitätsallee 1
    • 21335  Lüneburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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