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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  • 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.

ZeitschriftBMJ Open
Anzahl der Seiten11
PublikationsstatusErschienen - 01.08.2022

Bibliographische Notiz

Funding Information:
HB received consultancy fees, reimbursement of congress attendance and travel costs as well as payments for lectures from Psychotherapy and Psychiatry Associations as well as Psychotherapy Training Institutes in the context of E-Mental-Health topics. He has been the beneficiary of study support (third-party funding) from several public funding organisations. MBa and MK are employees of BARMER. KD is a member of the Janssen Pharmaceuticals ‘Steering Committee Neuroscience’. MF, EH, DL and DDE are stakeholders of the GET.ON Institut für Online Gesundheitstrainings (operating under the registered brand ‘HelloBetter’), which aims to implement scientific findings related to digital health interventions into routine care. HelloBetter distributes the digital intervention for insomnia that is used in this study. CMM received research grant from Canopy Health, Eisai, Idorsia and Lallemand Health Solutions; he served as consultant to Eisai, Idorsia, Pear Therapeutics, Sunovion and Weight Watchers, and received royalties from Mapi Research Trust. DDE has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed, German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. None of the other authors declare any conflict of interest.

Funding Information:
The described work was supported by funding from the Innovationsfonds of the German Federal Joint Committee (Gemeinsamer Bundesausschuss/ G-BA; grant 01NVF18030).We also acknowledge support by the Open Access Publication Fund of the University of Freiburg.

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