TY - JOUR

T1 - Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I)

T2 - a randomised controlled trial (iSleep well)

AU - Benz, Fee

AU - Grolig, L.

AU - Hannibal, Sandy

AU - Buntrock, Claudia

AU - Cuijpers, Pim

AU - Domschke, Katharina

AU - Ebert, David D.

AU - Ell, Johanna

AU - Janneck, M.

AU - Jenkner, Carolin

AU - Johann, Anna F.

AU - Josef, A.

AU - Kaufmann, Martin

AU - Koß, A.

AU - Mallwitz, Tim

AU - Mergan, Hamid

AU - Morin, Charles M.

AU - Riemann, Dieter

AU - Riper, Heleen

AU - Schmid, Stephanie R.

AU - Smit, Filip

AU - Spille, Lukas

AU - Steinmetz, Lisa

AU - Van Someren, Eus J.W.

AU - Spiegelhalder, Kai

AU - Lehr, Dirk

N1 - Publisher Copyright: © The Author(s) 2024.

PY - 2024/12

Y1 - 2024/12

N2 - 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.

AB - 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.

KW - CBT-I

KW - Cognitive behavioural therapy for insomnia

KW - Digital

KW - Face-to-face

KW - Guided internet intervention

KW - Insomnia

KW - Internet-delivered

KW - Non-inferiority trial

KW - Randomised controlled trial

KW - Psychology

UR - http://www.scopus.com/inward/record.url?scp=85195625221&partnerID=8YFLogxK

U2 - 10.1186/s13063-024-08214-6

DO - 10.1186/s13063-024-08214-6

M3 - Journal articles

C2 - 38858707

AN - SCOPUS:85195625221

VL - 25

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 371

ER -