Chronic insomnia (CI) often co-occurs with depression and anxiety, and treatment may positively impact mood. This ongoing study collected real-world data on changes in insomnia, depression, and anxiety symptoms among adults with CI treated with a prescription digital therapeutic (PDT) delivering cognitive-behavioral therapy for insomnia (CBT-I; Somryst®, previously SHUTi).

This prospective, single-arm, pragmatic clinical study enrolled adults (≥18 years) in the US with CI and mobile device access. The PDT consists of six core modules completed over 6–9 weeks. In this interim analysis, participants completed the Insomnia Severity Index (ISI), 8-item Patient Health Questionnaire (PHQ-8), and Generalized Anxiety Disorder-7 scale (GAD-7) and other self-reported outcomes—at screening (baseline/prior to Core 1), end of treatment (Day 63), and 6-month follow-up (Day 243).

Mean ISI scores decreased (p<0.0001) from baseline (n=991) to post-treatment (n=777;18.8 vs 11.3) and to Day 243 (n=193; 18.8 vs 12.1). Mean GAD-7 scores improved from baseline to Day 63 (n=744; p<0.0001, Cohen’s d = 0.48) and to Day 243 (n=186; p<0.0001, d = 0.45). Similarly, PHQ-8 scores improved from baseline to Day 63 (n=747; p<0.001, d = 0.76) and to Day 243 (n=186; p<0.0001, d = 0.60). These patterns persisted across baseline anxiety and depressive severity levels among people with any baseline depressive or anxiety symptoms (all p<0.05 for depression, all p<0.0001 for anxiety), with large effect sizes observed for severe anxiety (d=1.43 Day 63, d=1.55 Day 243) and for moderate to severe depression (d range = 0.96-1.51).

In this study, treatment with digital CBT-I was associated with significant reductions in ISI, anxiety, and depression at posttreatment and at 6 months. The largest observed decreases in GAD-7 and PHQ-8 scores were among people with more severe baseline mood symptoms.

Pear Therapeutics (US), Inc.

This analysis examined the impact of a digital therapeutic for treating chronic insomnia (currently marketed as Somryst®, at the time called Sleep Healthy Using The internet [SHUTi]) on healthcare resource use (HCRU) by comparing patients treated with the digital cognitive behavioral therapy for insomnia (dCBTi) to patients not treated with dCBTi, but with insomnia medications.

A retrospective observational study using health claims data was conducted in two cohorts across the United States: patients who registered for dCBTi (cases) between June 1, 2016 and October 31, 2018 (index date) vs. patients who did not register for dCBTi but initiated a second prescription for an insomnia medication in the same time period (controls). Observation period was 16–24 months. No other inclusion/exclusion criteria were used. Control patients were matched using a nearest neighbor within-caliper matching without replacement approach. Incidence rates for HCRU encounter type were calculated using a negative binomial model for both cohorts. Costs were estimated by multiplying HCRU by published average costs for each medical resource.

Evaluated were 248 cases (median age 56.5 years, 57.3% female, 52.4% treated with sleep-related medications) and 248 matched controls (median age 55.0 years, 56.0% female, 100.0% treated with sleep-related medications). Over the course of 24 months post-initiation, cases had significantly lower incidences of inpatient stays (55% lower, IRR: 0.45; 95% CI: 0.28–0.73; P=0.001), significantly fewer emergency department (ED) visits without inpatient admission (59% lower; IRR: 0.41; 95% CI: 0.27–0.63; P<0.001), and significantly fewer hospital outpatient visits (36% lower; IRR: 0.64; 95% CI: 0.49–0.82; P<0.001). There was also a trend for fewer ambulatory surgical center visits (23% lower; IRR: 0.77; 95% CI: 0.52–1.14; P=0.197) and fewer office visits (7% lower; IRR: 0.93; 95% CI: 0.81–1.07; P=0.302) with the use of SHUTi. Use of sleep medications was more than four times greater in controls vs. cases, with 9.6 (95% CI: 7.88–11.76) and 2.4 (95% CI: 1.91–2.95) prescriptions/patient, respectively (P<0.001). All-cause per-patient HCRU costs were $8,202 lower over 24 months for cases vs. controls, driven primarily by a lower incidence of hospitalizations (-$4,996 per patient) and hospital outpatient visits (-$2,003 per patient).

Patients with chronic insomnia who used a digital CBTi treatment had significant and durable real-world reductions in hospital inpatient stays, ED visits, hospital outpatient visits, and office visits compared to matched controls treated with medications.

Pear Therapeutics (US), Inc.

Insomnia treatment using an internet-based cognitive–behavioural therapy for insomnia (CBT-I) program reduces depression symptoms, anxiety symptoms and suicidal ideation. However, the speed, longevity and consistency of these effects are unknown.

To test the following: whether the efficacy of online CBT-I was sustained over 18 months; how rapidly the effects of CBT-I emerged; evidence for distinct trajectories of change in depressive symptoms; and predictors of these trajectories.

A randomised controlled trial compared the 6-week Sleep Healthy Using the Internet (SHUTi) CBT-I program to an attention control program. Adults (N=1149) with clinical insomnia and subclinical depression symptoms were recruited online from the Australian community.

Depression, anxiety and insomnia decreased significantly by week 4 of the intervention period and remained significantly lower relative to control for >18 months (between-group Cohen's d=0.63, 0.47, 0.55, respectively, at 18 months). Effects on suicidal ideation were only short term. Two depression trajectories were identified using growth mixture models: improving (95%) and stable/deteriorating (5%) symptoms. More severe baseline depression, younger age and limited comfort with the internet were associated with reduced odds of improvement.

Online CBT-I produced rapid and long-term symptom reduction in people with subclinical depressive symptoms, although the initial effect on suicidal ideation was not sustained.