Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from acute insomnia to chronic insomnia: study protocol for a randomised controlled trial.

Previous evidence suggested that online self-guided sleep intervention is efficacious in improving treatment outcomes in patients with chronic insomnia [corrected]. However, research on online sleep interventions targeting acute insomnia [corrected] has been scarce. This study aims to evaluate the effectiveness of brief e-aid cognitive behavioural therapy for insomnia (eCBTI) in preventing transition from acute insomnia to chronic insomnia [corrected]. This is a pragmatic two-arm multicentre, randomised controlled trial comparing eCBTI with treatment as usual (TAU) in outpatients. Two hundred patients with acute insomnia [corrected] (as defined by DSM-5) will be recruited. Patients will be randomly assigned to receive 1 week eCBTI via a Smartphone application, or to receive TAU. Treatment effects will be assessed at 1 week and 3 months after intervention. The primary outcome of the study, whether the eCBTI program is sufficient in preventing transition from short-term to chronic insomnia [corrected], is measured by the Insomnia Severity Index. Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale. Additionally, the Hospital Anxiety and Depression Scale and the Short-Form 12-Item Health Survey will be used for measurement of mood symptoms and quality of life. Ethical approval for the study has been obtained from the Ethics Committee of Southern Medical University (reference number: NFEC-2017-131). The results of the investigation will be published in scientific papers. The data from the investigation will be made available online if necessary. NCT03302455 (clinicaltrials.gov). Date of registration: October 5, 2017.

Yang Y ，Luo X ，Paudel D ，Zhang J ，Li SX ，Zhang B ... -  《BMJ Open》

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》

Adjunctive Internet-delivered cognitive behavioural therapy for insomnia in men with depression: A randomised controlled trial.

Glozier N ，Christensen H ，Griffiths KM ，Hickie IB ，Naismith SL ，Biddle D ，Overland S ，Thorndike F ，Ritterband L ... -  《-》

Online insomnia treatment and the reduction of anxiety symptoms as a secondary outcome in a randomised controlled trial: The role of cognitive-behavioural factors.

Gosling JA ，Batterham P ，Ritterband L ，Glozier N ，Thorndike F ，Griffiths KM ，Mackinnon A ，Christensen HM ... -  《-》

Light-enhanced cognitive behavioural therapy for sleep and fatigue: study protocol for a randomised controlled trial during chemotherapy for breast cancer.

Bean HR ，Stafford L ，Little R ，Diggens J ，Ftanou M ，Alexander M ，Francis PA ，Bei B ，Wiley JF ... -  《Trials》