Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial.

IMPORTANCE

Although cognitive behavior therapy for insomnia (CBT-I) has been established as the first-line recommendation for the millions of adults with chronic insomnia, there is a paucity of trained clinicians to deliver this much needed treatment. Internet-delivered CBT-I has shown promise as a method to overcome this obstacle; however, the long-term effectiveness has not been proven in a representative sample with chronic insomnia.

OBJECTIVE

To evaluate a web-based, automated CBT-I intervention to improve insomnia in the short term (9 weeks) and long term (1 year).

DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial comparing the internet CBT-I with internet patient education at baseline, 9 weeks, 6 months, and 1 year. Altogether, 303 adults with chronic insomnia self-referred to participate, of whom 151 (49.8%) reported at least 1 medical or psychiatric comorbidity.

INTERVENTIONS

The internet CBT-I (Sleep Healthy Using the Internet [SHUTi]) was a 6-week fully automated, interactive, and tailored web-based program that incorporated the primary tenets of face-to-face CBT-I. The online patient education program provided nontailored and fixed online information about insomnia.

MAIN OUTCOMES AND MEASURES

The primary sleep outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index) and online sleep diary-derived values for sleep-onset latency and wake after sleep onset, collected prospectively for 10 days at each assessment period. The secondary sleep outcomes included sleep efficiency, number of awakenings, sleep quality, and total sleep time.

RESULTS

Among 303 participants, the mean (SD) age was 43.28 (11.59) years, and 71.9% (218 of 303) were female. Of these, 151 were randomized to the SHUTi group and 152 to the online patient education group. Results of the 3 primary sleep outcomes showed that the overall group × time interaction was significant for all variables, favoring the SHUTi group (Insomnia Severity Index [F3,1063 = 20.65, P < .001], sleep-onset latency [F3,1042 = 6.01, P < .001], and wake after sleep onset [F3,1042 = 12.68, P < .001]). Within-group effect sizes demonstrated improvements from baseline to postassessment for the SHUTi participants (range, Cohen d = 0.79 [95% CI, 0.55-1.04] to d = 1.90 [95% CI, 1.62-2.18]). Treatment effects were maintained at the 1-year follow-up (SHUTi Insomnia Severity Index d = 2.32 [95% CI, 2.01-2.63], sleep-onset latency d = 1.41 [95% CI, 1.15-1.68], and wake after sleep onset d = 0.95 [95% CI, 0.70-1.21]), with 56.6% (69 of 122) achieving remission status and 69.7% (85 of 122) deemed treatment responders at 1 year based on Insomnia Severity Index data. All secondary sleep outcomes, except total sleep time, also showed significant overall group × time interactions, favoring the SHUTi group.

CONCLUSIONS AND RELEVANCE

Given its efficacy and availability, internet-delivered CBT-I may have a key role in the dissemination of effective behavioral treatments for insomnia.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01438697.