Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006825

Trial Description

start of 1:1-Block title

Title

Effectiveness of a smartphone-based online-gratitude-training for a reduction of perseverative thinking

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

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

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This study aims on testing the effectivenes of a smartphone-based-online-gratitude-training

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Gratitude as a trait shows significant correlations to a couple of variables of psychological and behavioural disorders as well as measurments of wellbeeing.
Gratitude is e.g. one of the strongest protective factors for major depression, GAD and phobias. Gratitude increases the quality of sleep via positive thinking before falling asleep. In this random-controlled study the effectiveness of an internet-based training for the reduction of perseverative thinking such as worry and rumination is evaluated. The target group consists of adults (min.18 years old) with a high amount of perseverative thinking (Perseverative Thinking Questionaire, PTQ> 33) and access to intenet and smartphone.The participants are distributed per random to two groups. Group A gets access to the online-training "GET.ON Dankbarkeit", which consists of evidence based techniques and exerercises for the reduction of perseverative thinking. Group B gets access to the same training as Group A after 3 months. The participants of both groups complete online questionaires concerning symptomatology and wellbeeing before group admission, 4 weeks and 3 months after randomized group admission.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006825
  •   2014/10/23
  •   [---]*
  •   yes
  •   Approved
  •   AZ-2014-09k, Uni Marburg - Ethik-Komission des Fachbereichs Psychologie Gutenbergstr. 18 35037 Marburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Perseverative thinking: Worry /rumination
  •   F41.1 -  Generalized anxiety disorder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Arm 1: Group A: direct admission to the online-gratitude-training which consists of evidence based techniques and exerercises for the reduction of perseverative thinking.

    The online-training consists of 4 units with exerecises concerning gratitude. At the same time the participants use a special app on their smartphone in order to collect and photograph positive issues of the day and integrate them in a gratitude-meditation in the evening.


    The participants complete online questionaires concerning symptomatology and wellbeeing before group admission, 4 weeks and 3 months after randomized group admission

  •   Arm 2: Group B: admission after 3 months of waiting.

    The participants complete online-questionaires concerning symptomatology and wellbeeing
    before group admission, 4 weeks and 3 months after randomized group admission.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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, 4 weeks and 3 months after group admission)

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

t0= before group admission,
t1= 4 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 Questionnaire (CSQ, Attkisson & Zwick, 1982) (t1).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/08/01
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

high level of perseverative thinking

Internet

smartphone

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Participation in another training program of geton

Participation in a psychotherapeutic treatment

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Leuphana Universität LüneburgGET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Prof. Dr  Bernhard  Sieland 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Evangelische Hochschule TABORMarburger Institut für Religion und Psychotherapie
    • Mr.  Prof. Dr.  Henning  Freund 
    • Dürerstr. 43
    • 35039  Marburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Leuphana Universität LüneburgGET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Dr.  Dirk  Lehr 
    • Rotenbleicherweg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Leuphana Universität LüneburgGET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Dr.  Dirk  Lehr 
    • Rotenbleicherweg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und Verkehr Friedrichswall 1 30159 Hannover)
    • Günther-Wagner-Allee 12-16
    • 30177  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/01/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.