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)

Abstract

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.

Focus Group Study of Heart Failure Nurses’ Perceptions of the Feasibility of Cognitive Behavioral Therapy for Insomnia

“…Interventions targeted to the severity of insomnia or insomnia refractory to initial intervention may also be useful (Manber et al, 2015; Savard et al, 2022), cost-effective, and favored by participants (Koffel et al, 2021). Although these approaches are under investigation (Manber et al, 2022; Spiegelhalder et al, 2022), to our knowledge, no studies have addressed these approaches among adults with chronic HF. Given the high prevalence and negative consequences of insomnia in this population, these questions warrant further study.…”

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well)

“…Besides improved accessibility, iCBT-I might have further advantages. For example, patients can complete the programme at their own pace, at any time and from anywhere with no travel expenses, and barriers associated with the stigma of mental disorders might be reduced [ 18 , 19 ]. However, evidence on the non-inferiority of iCBT-I, relative to face-to-face treatment, remains insufficient.…”