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)
Pim Cuijpers,
Claudia Buntrock,
Harald Baumeister,
Michael Kühn,
Ann-Marie Küchler,
Lina Braun,
Natalie Bauereiss,
Dirk Lehr,
Katharina Domschke,
David Daniel Ebert,
Elena Heber,
Charles M Morin,
Morten Moshagen,
Martina Bader,
Kai Spiegelhalder,
Abdulwahab Al-Kamaly,
Fee Benz,
Maike Burkhardt,
Patrick Dülsen,
Marvin Franke,
Lukas Frase,
Kathrin Helm,
Terry Jentsch,
Anna Johann,
Andy Maun,
Kneginja Richter,
Julian Schiel,
Laura Simon,
Lukas Spille,
Hans-Günter Weeß,
Dieter Riemann
Affiliations
Pim Cuijpers
1 Department of Clinical, Neuro- and Developmental Psychology and World Health Organization Collaborating Center for Research and Dissemination of Psychological Interventions, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
Claudia Buntrock
Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nuremberg, Nuremberg, Germany
Harald Baumeister
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany
Michael Kühn
Vienna Institute of Demography, Austrian Academy of Sciences, Wittgenstein Centre for Demography and Global Human Capital (IIASA, OeAW, University of Vienna), Wien, Austria
Ann-Marie Küchler
Department of Clinical Psychology & Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany
Lina Braun
Clinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany
Natalie Bauereiss
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany
Dirk Lehr
5 Department of Psychology, Leuphana University Lüneburg, Lüneburg, Germany
Katharina Domschke
Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Freiburg, Germany
David Daniel Ebert
Department for Sport and Health Sciences, Chair for Psychology and Digital Mental Health Care, Technical University of Munich, Munich, Germany
Elena Heber
2Division of Online Health Training, Innovation Incubator, Leuphana University, Lueneburg, Germany
Charles M Morin
Centre d’étude des troubles du sommeil, Centre de recherche CERVO/Brain Research Center, Université Laval École de psychologie, Quebec, Quebec, Canada
Morten Moshagen
Department of Psychological Research Methods, Ulm University, Ulm, Germany
Martina Bader
Department of Psychological Research Methods, Ulm University, Ulm, Germany
Kai Spiegelhalder
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Abdulwahab Al-Kamaly
Department of Medicine, Institute of General Practice/Family Medicine, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Fee Benz
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Maike Burkhardt
BARMER, Schwäbisch-Gmünd, Germany
Patrick Dülsen
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany
Marvin Franke
Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany
Lukas Frase
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Kathrin Helm
Department of Medicine, Institute of General Practice/Family Medicine, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Terry Jentsch
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Anna Johann
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Andy Maun
Department of Medicine, Institute of General Practice/Family Medicine, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Kneginja Richter
University Clinic for Psychiatry and Psychotherapy, Paracelsus Medical University, Nuremberg, Germany
Julian Schiel
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Laura Simon
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany
Lukas Spille
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Hans-Günter Weeß
Interdisciplinary Center of Sleep, Pfalzklinikum, Klinikum für Psychiatrie und Neurologie AdöR, Klingenmünster, Germany
Dieter Riemann
Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
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.
