Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well)
F. Benz,
L. Grolig,
S. Hannibal,
C. Buntrock,
P. Cuijpers,
K. Domschke,
D. D. Ebert,
J. Ell,
M. Janneck,
C. Jenkner,
A. F. Johann,
A. Josef,
M. Kaufmann,
A. Koß,
T. Mallwitz,
H. Mergan,
C. M. Morin,
D. Riemann,
H. Riper,
S. R. Schmid,
F. Smit,
L. Spille,
L. Steinmetz,
E. J. W. Van Someren,
K. Spiegelhalder,
D. Lehr
Affiliations
F. Benz
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
L. Grolig
Department of Health Psychology and Applied Biological Psychology, Institute of Sustainability Psychology, Leuphana University of Lüneburg
S. Hannibal
Department of Health Psychology and Applied Biological Psychology, Institute of Sustainability Psychology, Leuphana University of Lüneburg
C. Buntrock
Institute of Social Medicine and Health Systems Research, Medical Faculty, Otto-von-Guericke-University
P. Cuijpers
Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam
K. Domschke
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
D. D. Ebert
Psychology & Digital Mental Health Care, Department of Health Sciences, Technical University Munich
J. Ell
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
M. Janneck
Institute for Interactive Systems, Department of Electrical Engineering and Computer Science, Technische Hochschule Lübeck
C. Jenkner
Clinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg
A. F. Johann
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
A. Josef
Clinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg
M. Kaufmann
Clinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg
A. Koß
Clinical Trials Unit, Medical Center, Faculty of Medicine, University of Freiburg
T. Mallwitz
Institute for Interactive Systems, Department of Electrical Engineering and Computer Science, Technische Hochschule Lübeck
H. Mergan
Institute for Interactive Systems, Department of Electrical Engineering and Computer Science, Technische Hochschule Lübeck
C. M. Morin
École de Psychologie, Centre d’étude des troubles du sommeil, Centre de recherche CERVO/Brain Research Center, Université Laval
D. Riemann
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
H. Riper
Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam
S. R. Schmid
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
F. Smit
Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam
L. Spille
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
L. Steinmetz
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
E. J. W. Van Someren
Department of Sleep and Cognition, Netherlands Institute for Neuroscience, Royal Netherlands Academy of Arts and Sciences
K. Spiegelhalder
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg
D. Lehr
Department of Health Psychology and Applied Biological Psychology, Institute of Sustainability Psychology, Leuphana University of Lüneburg
Abstract Background Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. Methods This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). Discussion The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. Trial registration Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.
