Digital cognitive behavioral therapy for insomnia reduced Insomnia Severity Index scores and resulted in remission of insomnia for some patients, according to findings published in The Lancet Digital Health.
“Although several large-scale randomized controlled trials have shown the efficacy of digital cognitive behavioral therapy for insomnia (dCBT-I), there is a need to validate widespread dissemination of dCBT-I using recommended key outcomes for insomnia,” the researchers wrote. “To address crucial knowledge gaps regarding dCBT-I, we did [a randomized controlled trial] using a fully automated screening and intervention program among adults recruited from the general population in Norway.”
Øystein Vedaa, PhD, of the Norwegian Institute of Public Health, Voss District Psychiatric Hospital and St Olavs University Hospital, all in Norway, and colleagues performed a parallel-group, superiority trial comparing dCBT-I with online patient education about sleep. The interventions, which were available through a website at no cost to participants, included automated screening, informed consent and randomization processes, in addition to outcome evaluations. The researchers recruited adult patients aged greater than 18 years with regular internet access who scored 12 or higher on the Insomnia Severity Index (ISI).
Vedaa and colleagues randomly assigned patients 1:1 to dCBT-I, which included six core interactive sessions completed over 9 weeks, or to patient education; the latter served as the control group. The dCBT-I group addressed the primary topics that are discussed in face-to-face CBT-I including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene and relapse prevention. The patient education website included fixed information about the rate, causes and effects of insomnia, associated symptoms, when to see a health professional and basic lifestyle, environmental and behavioral recommendations about improving sleep (ie, sleep hygiene education). Change in ISI score from baseline to follow-up at 9 weeks served as the primary outcome, which the researchers evaluated in the intent-to-treat population.
The researchers enrolled 5,349 individuals in the online screening process between Feb. 26, 2016, and July 1, 2018. Of those patients, Vedaa and colleagues randomly assigned 1,721 to receive dCBT-I (868) or patient education (853). At the 9-week follow-up point, 584 (67%) participants in the dCBT-I group and 534 (63%) participants in the patient education group finished the ISI evaluation.
Participants in the dCBT-I group experienced a significantly greater decrease in ISI scores from baseline (mean score, 19.2 at baseline to 10.4 at 9-week follow-up) than those in the patient education group (mean score, 19.6 at baseline to 15.2 at 9-week follow-up; estimated mean difference, –4.7; 95% CI, –5.4 to –4.1). Compared with patient education, the number of sessions needed with dCBT-I was 2.7 (95% CI, 2.4-3.2) to achieve treatment response (defined as an ISI score reduction of 8) and 3.2 (95% CI, 2.8-3.8) to achieve insomnia remission (ISI score <8).
Vedaa and colleagues found that the dCBT-I group reported greater improvements in most secondary measures compared with the patient education group. Individuals in the dCBT-I group were significantly less likely to be using sleep medications at follow-up compared with the patient education group, with the decrease in the rate of sleep medication use from baseline to follow-up estimated to be approximately 16 percentage points for dCBT-I and 10 percentage points for patient education (OR = 0.49; 95% CI, 0.23-0.74).
The dCBT-I group also demonstrated a significantly greater decrease in fatigue according to the Chalder Fatigue Questionnaire scores (between-group effect sizes, –0•4; 95% CI, –0•53 to –0•27). The researchers observed no differences between the groups regarding total sleep time or perceived physical health according to the SF-12 physical health score. Vedaa and colleagues also observed no adverse events.
“This study is one of the largest [randomized controlled trials] to date to examine the efficacy of fully automated dCBT-I in a community-based sample of adults with high levels of insomnia. It is also the largest [randomized controlled trial] to evaluate efficacy with the recommended standard outcomes for insomnia (ie, changes in ISI ratings and sleep–wake patterns as assessed using sleep diaries),” the researchers wrote. “Overall, our findings support those obtained in previous high-quality trials on the effects of fully automated dCBT-I for individuals with insomnia.”
Source: Healio