Randomized Noninferiority Trial of Telehealth Delivery of Cognitive Behavioral Treatment of Insomnia Compared to In-Person Care

ABSTRACT

Objective: Insomnia is prevalent and is associated with a range of negative sequelae. Cognitive behavioral treatment for insomnia (CBT-I) is the recommended intervention, but availability is limited. Telehealth provides increased access, but its efficacy is not certain. The objective of this study was to compare the efficacy of CBT-I delivered by telehealth to in-person treatment and to a waitlist control.

Methods: Individuals with DSM-5 insomnia disorder (n = 60) were randomized to telehealth CBT-I, in-person CBT-I, or 8-week waitlist control. CBT-I was delivered over 6–8 weekly sessions by video telehealth or in-person in an outpatient clinic. Follow-up assessments were at 2 weeks and 3 months posttreatment. The Insomnia Severity Index (ISI) was the primary outcome. Change in ISI score was compared between the CBT-I group in an intent-to-treat, noninferiority analysis using an a priori margin of −3.0 points. All analyses were conducted using mixed-effects models. Data collection occurred from November 2017–July 2020.

Results: The mean (SD) change in ISI score from baseline to 3-month follow-up was −7.8 (6.1) points for in-person CBT-I, −7.5 (6.9) points for telehealth, and −1.6 (2.1) for waitlist, and the difference between the CBT-I groups was not statistically significant (t₂₈ = −0.98, P = .33). The lower confidence limit of this between-group difference in the mean ISI changes was greater than the a priori margin of −3.0 points, indicating that telehealth treatment was not inferior to in-person treatment. There were significant improvements on most secondary outcome measures but no group differences.

Conclusions: Telehealth CBT-I may produce clinically significant improvements in insomnia severity that are noninferior to in-person treatment. CBT-I is also associated with significant gains across a range of domains of functioning. Telehealth is a promising option for increasing access to treatment without loss of clinical gains.

Trial Registration: ClinicalTrials.gov identifier: NCT03328585