Trial document




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  DRKS00017737

Trial Description

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Title

Efficacy of an internet intervention for sleep disorder in students (GET.Sleep): a randomized controlled trial

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Trial Acronym

GET.Sleep

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URL of the Trial

https://www.studicare.com/schlaf

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Brief Summary in Lay Language

Sleep disorders are a widespread phenomenon, which can have serious consequences for the affected person. In particular, the daytime sleepiness associated with the sleep disorder causes impairments in social, occupational and other ailments. Internet-based interventions can be used to treat sleep disorders. The aim of the study is to evaluate such an intervention in terms of acceptance and efficacy. 90 students suffering from sleep disorders should participate in the study. The intervention consists of six online modules. The participants will be supported by an eCoach who will provide feedback on demand on the modules. In addition, the participant will be given exercises for everyday life. Regular reminders of training lessons, which participants receive via a mobile app, should help them to transfer strategies into everyday life.

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Brief Summary in Scientific Language

Sleep disorders are a widespread phenomenon in society. Many students suffer from insomnia. A study by Gaultney (2010) showed prevalence rates among students of up to 27%. The sleep disorder or the associated daytime fatigue causes clinically significant suffering or impairment in social, occupational or other important functional areas such as academic achievement. Empirically validated treatments for insomnia that meet the criteria of the American Psychological Association include cognitive-behavioural therapy for insomnia (CBT-I), stimulus control method, sleep restriction method, progressive muscle relaxation, and paradoxical intention. Internet interventions can be an effective way to treat affected individuals. Compared to traditional treatment options for students like psychological counselling centres at universities, internet- and mobile-based interventions have several advantages, such as accessibility independent of time and place, low-threshold access and anonymity. International studies show that internet-based interventions have the potential to reach those who are unable or unwilling to make use of traditional services. The aim of the study is to evaluate the acceptance and effectiveness of a guided internet- and mobile-based intervention for the treatment of primary insomnia in students. In a randomized controlled trial (N = 90), individuals with sleep disorders (Insomnia Severity Index [ISI] > 10) are randomly assigned to the internet intervention or an active control group. The assessments take place at baseline, 8 weeks and 6 months after randomisation and include questionnaires and diagnostic interviews. The primary outcome is primary Insomnia (ISI) after 8 weeks. Secondary outcomes include depressive symptoms, quality of life, participant training satisfaction, worries, procrastination, recovery from sleep, sleep efficiency and sleep quality. The participants are supported by an eCoach, who provides individual feedback on demand. The intervention also includes exercises and training reminders in everyday life referred to as tiny tasks.

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Organizational Data

  •   DRKS00017737
  •   2019/08/01
  •   [---]*
  •   yes
  •   Approved
  •   481_18B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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

  •   F51 -  Nonorganic sleep disorders
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Interventions/Observational Groups

  •   Intervention group - The intervention consists of six weekly sessions, each scheduled for approximately 30-45 minutes. For all completed modules a feedback is available on demand by a trained employee.
  •   Active control group - Participants receive psychoeducation on sleep disorders. They will receive access to the same intervention as the participants in the intervention group after a waiting period of 6 months.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Insomnia Severity Index (ISI)

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Secondary Outcome

Questionnaires:
Assessment at baseline, post-treatment and 6-months follow-up:
SF-B: Restfulness of sleep
PSQI: Pittsburgh Sleep Quality Index
PSWQ-3: Penn State Worry Questionnaire Ultra
IS-K: Irritation-Scale
REQ: Recovery Experience Questionnaire
ReaQ: The Recreation Experience and Activity Questionnaire
PFS: Prokrastination Questionnaire for students
PSS: Presenteeism Scale for Students
Diagnostic Interview to assess Primary Insomnia and current Major Depressive Disorder


Screening:
BDI: Beck-Depressions-Inventar

Assessment at post-treatment (T2):
CSQ-8 - Client Satisfaction Questionnaire

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2019/08/11
  •   90
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- ISI > 10
- Internet access
- Student status
- Valid email adress
- Providing informed consent

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Exclusion Criteria

- Age < 18
- Receiving another psychological treatment or being on the waitlist for treatment
- Suffering from a severe mental disorder
- Risk of suicide (BDI-II suicidality > 1)

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Addresses

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    • Lehrstuhl für Klinische Psychologie und PsychotherapieFriedrich-Alexander Universität Erlangen-Nürnberg
    • Mr.  Dr  David Daniel  Ebert 
    • Nägelsbachstr. 25a
    • 91025  Erlangen
    • Germany
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    • Friedrich-Alexander Universität Erlangen-NürnbergLehrstuhl für Klinische Psychologie und Psychotherapie
    • Ms.  M.Sc.-Psych.  Karina  Saruhanjan 
    • Nägelsbachstr.25a
    • 91052  Erlangen
    • Germany
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    • Friedrich-Alexander Universität Erlangen-NürnbergLehrstuhl für Klinische Psychologie und Psychotherapie
    • Ms.  M.Sc.-Psych.  Karina  Saruhanjan 
    • Nägelsbachstr.25a
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Barmer GEK
    • Axel-Springer-Straße 44
    • 10969  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Prüfprotokoll
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* This entry means the parameter is not applicable or has not been set.