Prescription Digital Therapeutic for Insomnia Improves Sleep and Mental Health

A prescription digital therapeutic that delivers cognitive behavioral therapy for insomnia (CBT-I) meaningfully improved sleep and symptoms of depression and anxiety – especially among patients with severe insomnia. These study findings were published in Frontiers in Psychiatry.

The first-line treatment option for chronic insomnia is CBT-I, which is typically delivered over 4 to 8 sessions. In March 2020, the Food and Drug Administration (FDA) cleared a prescription digital therapeutic for insomnia. This mobile application demonstrated efficacy in reducing insomnia severity during randomized clinical trials, but relatively little is known about its effects in a real-world setting.

To this aim, researchers conducted a pragmatic, prospective, single-arm clinical study (ClinicalTrials.gov Identifier: NCT04325464) to characterize treatment adherence, insomnia improvement, and changes in anxiety and depression symptoms associated with a prescription digital therapeutic for insomnia. Adult participants with chronic insomnia living in the United States were recruited through sleep clinician referral, from a waiting list of patients interested in a mobile version of a previous browser-based CBT-I intervention, and individuals who conducted insomnia treatment-related internet searches.

The participants accessed the prescription digital therapeutic on a mobile device over a 9-week intervention period. The mobile application delivered CBT-I through 6 interactive treatment cores and daily sleep diaries used for tailoring treatment. The researchers used the Insomnia Severity Index (ISI), the Generalized Anxiety Disorder-7 scale (GAD-7), and the 8-item Patient Health Questionnaire (PHQ-8) to measure the effect of the prescription digital therapeutic on insomnia, anxiety, and depression.

A total of 1565 adults with chronic insomnia living in the United States, aged 22 to 75 years, were included in the analysis. The participants had a mean (SD) age of 46 (13.28) years and 74.7% were women. At baseline, 16.3% of participants had subthreshold ISI scores, 55.3% had moderate scores, and 28.3% had severe scores.

Among participants who completed assessments for all 6 cores of treatment (48.4% of participants), the researchers found that the mean ISI score decreased from 18.8 at baseline to 9.9 at the end of treatment. Relative to baseline, ISI scores continued to be lower at the immediate post-intervention (mean=11.0) and at the 6-month (mean=11.6) and 12-month (mean=12.2) follow-ups (all P <.001). Clinically meaningful response rates were higher among patients completing all 6 treatment cores.

The researchers also found that the prescription digital therapeutic was associated with significant decreases in GAD-7 and PHQ-8 scores at all measured time points following treatment (all P <.001).

“Results of this national study suggest that prior findings pertaining to [digital] CBT-I extend beyond tightly controlled clinical trials and generalize to real-world use among a diverse sample of US adults,” the researchers concluded.

Study limitations include the lack of a comparator group, low treatment adherence to the full CBT-I program, and attrition during the longest follow-up time points.

Disclosure: This research was supported by Pear Therapeutics (US), Inc. and by Nox Health, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

This article originally appeared on Psychiatry Advisor