The Implementation and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Primary Care: A Pilot Study

Background: Digital interventions delivering Cognitive Behavioral Therapy for insomnia (Digital CBTi) may increase utilization of effective care for a common and serious condition. A low-intensity implementation strategy may facilitate digital CBTi use in healthcare settings. This pilot study assessed the feasibility of implementing a digital CBTi in Veterans Health Administration (VA) primary care through iterative modifications to a low-intensity implementation strategy, while evaluating clinical outcomes of a specific digital CBTi program. Methods: A self-directed digital CBTi was implemented in the primary care clinics of a single VA facility using a cohort trial design that iteratively modified an implementation strategy over three 8-month phases. The phase 1 implementation strategy included (1) provider education; (2) point-of-care information via pamphlets; and (3) provider referral to digital CBTi through phone calls or messages. Phases 2 and 3 maintained these activities, while (1) adding a clinic-based coach who performed initial patient education and follow-up support contacts, (2) providing additional recruitment pathways, and (3) integrating the referral mechanism into provider workflow. Implementation outcomes included provider adoption, patient adoption, and acceptability. Clinical outcomes (insomnia severity, depression severity, and sedative hypnotic use) were compared among enrollees at baseline and 10 weeks. Results: Across all phases 66 providers (48.9%) made 153 referrals, representing 0.38% of unique clinic patients. Of referrals, 77 (50.3%) enrolled in the study, 45 (29.4%) engaged in the program, and 24 (15.7%) completed it. Provider and patient adoption did not differ meaningfully across phases. Among enrollees, digital CBTi was acceptable and the Insomnia Severity Index decreased by 4.3 points (t = 6.41, p < 0.001) and 13 (18.6%) reached remission. The mean number of weakly sedative-hypnotic doses decreased by 2.2 (35.5%) (t = 2.39, p < 0.02). Conclusions: Digital CBTi implementation in VA primary care is feasible using low-intensity implementation strategy, resulting in improved clinical outcomes for users. However, iterative implementation strategy modifications did not improve adoption. The trial was registered at clinicaltrials.gov (NCT03151083). Conclusions: Digital CBTi implementation in VA primary care is feasible using low-intensity implementation strategy, resulting in improved clinical outcomes for users. However, iterative implementation strategy modifications did not improve adoption. The trial was registered at clinicaltrials.gov (NCT03151083).