Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial

Abstract

Background Although several large-scale randomised controlled trials have shown the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I), there is a need to validate widespread dissemination of dCBT-I using recommended key outcomes for insomnia. We investigated the effect of a fully automated dCBT-I programme on insomnia severity, sleep-wake patterns, sleep medication use, and daytime impairment.Methods We did a parallel-group superiority randomised controlled trial comparing dCBT-I with online patient education about sleep. The interventions were available through a free-to-access website, publicised throughout Norway, which incorporated automated screening, informed consent, and randomisation procedures, as well as outcome assessments. Adults (age ≥18 years) who had regular internet access and scored 12 or higher on the Insomnia Severity Index (ISI) were eligible for inclusion, and were allocated (1:1) to receive dCBT-I (consisting of six core interactive sessions to be completed over 9 weeks) or patient education (control group). Participants were masked to group assignment and had no contact with researchers during the intervention period. The primary outcome was the change in ISI score from baseline to 9-week follow-up, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02558647) and is ongoing, with 2-year follow-up assessments planned.

The effect of sleep–wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT

“…We extracted data for 1720 RCT participants as reported in the Intent to Treat analyses [ 23 ] (1 participant excluded due to corrupted data of the CSD). Completed CSD at baseline was 853 (Mean 11.0 days; SD = 0.71) for the SHUTi group and 867 (Mean 10.3 days; SD = 0.68) for the PE group.…”

“…The current study utilizes data from a recently published RCT [ 23 ] and the analyses reported were specified a priori in the trial protocol [ 24 ]. The RCT was pre-registered on the ClinicalTrials.gov website (NCT02558647).…”

“…The RCT was pre-registered on the ClinicalTrials.gov website (NCT02558647). The article on the RCT outcome [ 23 ] and trial protocol provide full details of the methodology and procedures. However, a brief overview is provided below.…”

Brief Research Report: A Pilot Study of Cognitive Behavioral Regulation Therapy (CBT-REG) for Young People at High Risk of Early Transition to Bipolar Disorders

“…The second module employs "behavioral regulation" (a modified version of behavioral activation that emphasizes the importance of preventing over-stimulation or excessive activation in those at risk of hypo/mania), alongside sessions targeting sleep-wake cycle or circadian regulation (with techniques derived from CBT for insomnia) (16,17). Which interventions are initiated is determined by whether sleep disturbances are characterized by insomnia (which is often linked to arousal or anxiety), hypersomnia, unstable patterns, or prolonged sleep onset latency with late waking time (which may be a marker of circadian dysrhythmia) (17)(18)(19)(20).…”

Digital cognitive behavioural therapy for insomnia: the answer to a major public health issue?

“…2 Øystein Vedaa and colleagues' study in The Lancet Digital Health is an excellent addition to this evidence. 3 The study assessed the effectiveness of an automated dCBT-I intervention, Sleep Healthy Using the Internet (SHUTi), in a well conducted large-scale (n=1721) randomised controlled trial in Norway. The control group received online sleep education.…”