JMIR Publications

ABSTRACT

Background:

Cognitive behavioral therapy for insomnia has proven to be an effective treatment; however, its accessibility is limited. To address this issue, digital therapeutics for insomnia (DTx-Is) have emerged as a potential solution to enhance access.

Objective:

We opted to conduct a decentralized clinical trial (DCT) to minimize the necessity for participants to attend in-person hospital visits, aiming to evaluate the clinical efficacy of a DTx-I, “WELT-I,” and assess the feasibility and utility of DCTs for validating DTx-Is.

Methods:

A double-blind, sham-controlled randomized DCT was conducted with 68 participants who met the diagnostic criteria for insomnia (n=33 in the WELT-I group, n=35 in the control group). Sleep metrics and self-reported psychiatric questionnaires, including Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16), were measured over 7 weeks. Except for one on-site visit for gathering written consent, all trial procedures were conducted remotely. The primary outcome was sleep efficiency. To assess the utility of DCTs, the retention rate, participants’ satisfaction, and time to reach the recruitment goal were evaluated.

Results:

WELT-I significantly improved sleep efficiency (least-squares difference=8.28, p-value=0.04) and DBAS-16 scores (least-squares difference=−1.03, p-value=0.01) compared with the sham app. Recruitment was completed within 73 days, and WELT-I achieved a retention rate of 82.14% and a mean satisfaction score of 7.21 out of 10.

Conclusions:

WELT-I demonstrated significant therapeutic efficacy in improving sleep efficiency. The DCT approach enabled rapid recruitment, high retention, and strong participant satisfaction, highlighting its potential as a scalable and efficient method for validating DTx-Is.