Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep)

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Authors

  • Kai Spiegelhalder
  • Harald Baumeister
  • Abdulwahab Al-Kamaly
  • Martina Bader
  • Natalie Bauereiss
  • Fee Benz
  • Lina Braun
  • Claudia Buntrock
  • Maike Burkhardt
  • Pim Cuijpers
  • Katharina Domschke
  • Patrick Dülsen
  • Marvin Franke
  • Lukas Frase
  • Elena Heber
  • Kathrin Helm
  • Terry Jentsch
  • Anna Johann
  • Ann Marie Küchler
  • Michael Kuhn
  • Andy Maun
  • Charles M. Morin
  • Morten Moshagen
  • Kneginja Richter
  • Julian Schiel
  • Laura Simon
  • Lukas Spille
  • Hans Günter Weeß
  • Dieter Riemann
  • David Daniel Ebert

INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.

Original languageEnglish
Article numbere058212
JournalBMJ Open
Volume12
Issue number8
Number of pages11
ISSN2044-6055
DOIs
Publication statusPublished - 01.08.2022

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