Trial document




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  DRKS00011862

Trial Description

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Title

Effectiveness of a smartphone-based online-gratitude-training with coaching on demand for the reduction of perseverative thinking

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Trial Acronym

[---]*

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URL of the Trial

https://geton-training.de/dankbarkeit.php

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Brief Summary in Lay Language

The online-training GET.ON Gratitude targets people that are inclined to ruminate and to worry and that want to reduce this tendency. Negative repetitive thoughts are a risk factor for the development and maintenance of various psychological disorders, amongst others depressive complaints. Gratitude is a positive emotion that is increasingly studied. While negative information is processed excessively when ruminating or worrying, gratitude is associated with shifting one’s attention to positive aspects.
The planned study aims at investigating the efficacy of an internet-based gratitude intervention. For this purpose adults with increased repetitive thoughts in terms of rumination and worry will be randomized in one of two groups.
Group A receives access to a five-week online training. The online training contains various exercises that aim at improving one’s own gratitude. The online training is supplemented by a mobile gratitude app with that participants have the chance to conduct a review of the day. Group B gets access to the same training as Group A after 3 months.

To evaluate the effectiveness of the internet-based intervention participants of both groups answer online questionnaires asking for their condition at three points in time (before randomization, 6 weeks and 3 month after completion of the intervention).

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Brief Summary in Scientific Language

Dispositional gratitude is significantly associated with a variety of mental and behavioral disorders, as well as measures of well-being (Review: Wood, Froh & Geraghty, 2010). For example gratitude is one of the strongest protective factors for Major Depression, generalized anxiety disorder and phobias (Kendler et al., 2003). Gratitude also improves sleeping quality through positive cognition prior to falling asleep.
In this randomized-controlled trial the efficacy of an internet-based training with coaching on demand for the reduction of perseverative thinking will be evaluated. The online-training will be compared with a waitlist control group.

The target group comprises adults that are at least 18 years old, that report elevated perseverative cognition (Perseverative Thinking Questionnaire, PTQ > 33) that have access to the internet and own a smartphone. The participants will be randomized to one of two groups.
Group A receives access to the online-training "GET.ON Gratitude" that comprises evidence-based techniques and exercises for the reduction of perseverative cognition. Group B gets access to the same training as Group A after 3 months (wailist control). Participants of both groups will complete online questionnaires about their condition prior to randomization and 6 weeks and 3 months after randomization.

The study is a replication study of a registered trial (reference number: DRKS00006825) but differs with regard to the intensity of coaching provided to the participants in the intervention group (on demand vs. coaching after each session).

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Organizational Data

  •   DRKS00011862
  •   2017/03/10
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  •   yes
  •   Approved
  •   EB-Antrag 201701-03-Lehr_Replikationen - Studie 2: Unterstützung auf Anfrage / coaching on demand, Ethikbeirat der Leuphana Universität Lüneburg http://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

  •   F32.0 -  Mild depressive episode
  •   Perseverative thinking: Worry /rumination
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Interventions/Observational Groups

  •   Group A: Access to the online-intervention "Get.On Gratitude", that comprises evidence-based techniques and exercises for the reduction of perseverative cognition.
    The online-intervention entails 5 training-sessions (with an average duration of 30-40 minutes each) that include exercises that foster gratitude. Additionally, participants use a particular App on their smartphones that offers the opportunity to record and photograph positive aspects of the day and to contemplate those in a daily closing gratitude-meditation.
    Online assessment about the participant’s condition take place prior to randomization, 6 weeks and 3 months after randomization. Coachning on demand is offered to the participants.
  •   Group B: admission after 3 months of waiting.

    The participants complete online-questionaires concerning symptomatology and wellbeeing
    before group admission, 6 weeks and 3 months after randomized group admission.
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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
  •   III
  •   N/A
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Primary Outcome

The Perseverative Thinking Questionnaire (PTQ; Ehring, T., Ulrike Zetsche, U., Weidacker, K., Wahl, K., Schönfeldd, S. & Ehlers, A. 2011) is measuring repetive perseverative thinking (before group admission, 6 weeks and 3 months after group admission). Primary test will be conducted after 6 weeks (t1).

Sreening instrument for group admission, PTQ cut-off> 33

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Secondary Outcome

t0= before group admission,
t1= 6 weeks after group admission
t2= 3 months after group admission

• Allgemeine Depressionsskala (ADS, Hautzinger & Bailer, 1993): measurement of depressive symptoms (t0, t1, t2).
• GAD 7 (Löwe, Spitzer, Zipfel & Herzog, 2002): measurement of the severity of symptoms of generalized anxiety (t0, t1, t2).
• Insomnia Severity Index (ISI, Bastien, Vallières, & Morin, 2001): Questionaire of sleeping problems (t0, t1, t2).
• Brief Penn State Worry Questionaire (Berle, Starcevic, Moses, Hannan, Milicevic & Sammut, 2011): Questionaire of the degree of worry (t0, t1, t2).
• Connor-Davidson Resilience Scale (CD-RISC, Connor & Davidson, 2003): Measurement of resilience (t0, t1, t2).
• Berliner Social Support Skalen (BSSS, Schwarzer & Schulz, 2000). Measurement of social support, need for social support and the quest for support (t0, t1, t2).
• Zentralität-Skala (Z7-Skala; Huber, 2004): Measurement of the centrality of religiosity in personality, (t0, t1, t2).
• The Gratitude Questionnaire-6. (McCullough, Emmons & Tsang, 2002). own adaption of the standart-instrument of measuring gratitude (t0, t1, t2).
• Questionaire for the reasons of drop out (own development) (t1).
• Questionaire of satisfaction with the training-program, own development based on the questionaire of: (ZUF 8, Schmidt, Lamprecht, Wittmann, 1989) and the Client Satisfaction Quest

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/02/23
  •   260
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

- high level of perseverative thinking
- Internet Access
- Smartphone

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Exclusion Criteria

- Participation in another training program of GET.ON training online- Participation in a psychotherapeutic treatment
- Being on a waiting list for psychotherapy
- Suicidal risk (BDI item 9 > 1)

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Addresses

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    • Leuphana UniversitätProfessur für Gesundheitspsychologie und Angewandte Biologische Psychologie Institut für Psychologie
    • Mr.  Prof. Dr.  Dirk  Lehr 
    • Scharnhorststr. 1
    • 21335  Lüneburg
    • Germany
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    • Evangelische Hochschule TABORMarburger Institut für Religion und Psychotherapie
    • Mr.  Prof. Dr.  Henning  Freund 
    • Dürerstr. 43
    • 35039 
    • Germany
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    • Leuphana UniversitätProfessur für Gesundheitspsychologie und Angewandte Biologische Psychologie Institut für Psychologie
    • Mr.  Prof. Dr.  Dirk  Lehr 
    • Scharnhorststr. 1
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität LüneburgProfessur für Gesundheitspsychologie und Angewandte Biologische Psychologie Institut für Psychologie
    • Ms.  M.Sc. Psych.  Dörte  Behrendt 
    • Scharnhorststr. 1
    • 21335  Lüneburg
    • Germany
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Sources of Monetary or Material Support

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    • Leuphana UniversitätProfessur für Gesundheitspsychologie und Angewandte Biologische Psychologie Institut für Psychologie
    • Mr.  Prof. Dr.  Dirk  Lehr 
    • Scharnhorststr. 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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