TY - JOUR A1 - Spiegelhalder, Kai A1 - Baumeister, Harald A1 - Al-Kamaly, Abdulwahab A1 - Bader, Martina A1 - Bauereiss, Natalie A1 - Benz, Fee A1 - Braun, Lina A1 - Buntrock, Claudia A1 - Burkhardt, Maike A1 - Cuijpers, Pim A1 - Domschke, Katharina A1 - Dülsen, Patrick A1 - Franke, Marvin A1 - Frase, Lukas A1 - Heber, Elena A1 - Helm, Kathrin A1 - Jentsch, Terry A1 - Johann, Anna A1 - Küchler, Ann-Marie A1 - Kuhn, Michael A1 - Lehr, Dirk A1 - Maun, Andy A1 - Morin, Charles M A1 - Moshagen, Morten A1 - Richter, Kneginja A1 - Schiel, Julian A1 - Simon, Laura A1 - Spille, Lukas A1 - Weeß, Hans-Günter A1 - Riemann, Dieter A1 - Ebert, David Daniel T1 - 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) JF - BMJ Open N2 - IntroductionIt 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 analysisIn 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 disseminationThe 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 numberDRKS00021503. Y1 - 2022 U6 - https://doi.org/10.1136/bmjopen-2021-058212 SN - 2044-6055 VL - 12 IS - 8 PB - BMJ ER -