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

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. 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). 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 number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Benz F ，Grolig L ，Hannibal S ，Buntrock C ，Cuijpers P ，Domschke K ，Ebert DD ，Ell J ，Janneck M ，Jenkner C ，Johann AF ，Josef A ，Kaufmann M ，Koß A ，Mallwitz T ，Mergan H ，Morin CM ，Riemann D ，Riper H ，Schmid SR ，Smit F ，Spille L ，Steinmetz L ，Van Someren EJW ，Spiegelhalder K ，Lehr D ... -  《Trials》

Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder.

Expert guidelines recommend cognitive-behavioural therapy (CBT) as a first-line treatment for obsessive-compulsive disorder (OCD), but the majority of patients with OCD do not have access to CBT. Internet-delivered CBT (ICBT) has the potential to make this evidence-based treatment more accessible while requiring less therapist time than traditional face-to-face (f2f) CBT. Data from six clinical trials suggest that ICBT for OCD is both efficacious and cost-effective, but whether ICBT is non-inferior to traditional f2f CBT for OCD is yet unknown. A single-blind, randomised, controlled, non-inferiority trial comparing therapist-guided ICBT, unguided ICBT and individual (f2f) CBT for adult OCD patients. The primary objective is to investigate whether ICBT is non-inferior to gold standard f2f CBT. Secondary objectives are to investigate if ICBT is equally effective when delivered unguided, to establish the cost-effectiveness of ICBT and to investigate if the treatment outcome differs between self-referred and clinically referred patients. Participants will be recruited at two specialist OCD clinics in Stockholm and also through online self-referral. Participants will be randomised to one of three treatment conditions: F2f CBT, ICBT with therapist support or unguided ICBT. The total number of participants will be 120, and masked assessments will be administered at baseline, biweekly during treatment, at post-treatment and at 3-month and 12-month follow-ups. The main outcome measure is the clinician-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 3-month follow-up. The margin of non-inferiority is set to 3 points on the Y-BOCS using a 90% CI. The study has been approved by the Regional Ethics Board of Stockholm (REPN 2015/1099-31/2) and registered at Clinicaltrials.gov (NCT02541968). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. NCT02541968; Pre-results.

Rück C ，Lundström L ，Flygare O ，Enander J ，Bottai M ，Mataix-Cols D ，Andersson E ... -  《BMJ Open》

Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults.

Olthuis JV ，Watt MC ，Bailey K ，Hayden JA ，Stewart SH ... -  《Cochrane Database of Systematic Reviews》

Internet-Delivered Cognitive Behavioural Therapy for Major Depression and Anxiety Disorders: A Health Technology Assessment.

Health Quality Ontario 《-》

Randomised controlled trial on the effect of internet-delivered computerised cognitive-behavioural therapy on patients with insomnia who remain symptomatic following hypnotics: a study protocol.

Insomnia has severe consequences for health. Primary care physicians in Japan commonly provide hypnotics, which is far from optimal. The recommended treatment for insomnia is cognitive-behavioural therapy (CBT). Access to trained therapists, however, is limited. Rather than face-to-face CBT, several researchers have studied internet-delivered computerised CBT (ICBT). This paper describes the study protocol for a randomised controlled trial (RCT) to evaluate effectiveness and feasibility of our newly developed five-step ICBT as an adjunct to usual care (UC) compared with UC alone for patients with insomnia who remain symptomatic following hypnotics. This proposed exploratory RCT comprises two parallel groups (ICBT+UC and UC alone) consisting of 15 participants each (n=30) diagnosed with insomnia who remain symptomatic after pharmacotherapy. We aim to evaluate the effectiveness of six intervention weeks. The primary outcome of insomnia severity will be the Pittsburgh Sleep Quality Index (PSQI) at week 6. Secondary outcomes include sleep onset latency, total sleep time, sleep efficiency extracted from PSQI, current feeling of refreshment and perceived soundness of sleep measured using visual analogue scale, number of awakenings, anxiety by Hospital Anxiety and Depression Scale, depression by Center for Epidemiologic Studies Depression Scale and quality of life by Euro Qol-5D. All measures will be assessed at weeks 0 (baseline), 6 (postintervention) and 12 (follow-up), and intention-to-treat analysis will be applied. The statistical analysis plan has been developed considering design of field materials. This study will be conducted at the academic outpatient clinic of Chiba University Hospital, Japan. Ethics approval was granted by the Institutional Review Board of Chiba University Hospital. All participants will be required to provide written informed consent. The trial will be implemented and reported in accordance with Consolidated Standards of Reporting Trials recommendations. UMIN000021509; Pre-results.

Sato D ，Yoshinaga N ，Nagai E ，Hanaoka H ，Sato Y ，Shimizu E ... -  《BMJ Open》