Efficacy of an Internet-Delivered Intervention for Improving Insomnia Severity and Functioning in Veterans: Randomized Controlled Trial.

ABSTRACT

BACKGROUND: Despite a growing evidence base that internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) is associated with decreased insomnia severity, its efficacy has been minimally examined in veterans. OBJECTIVE: The objective of this study was to evaluate the efficacy of an unguided iCBT-I (Sleep Healthy Using the Internet [SHUTi]) among veterans. METHODS: We conducted a single-blind, randomized controlled trial in Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn veterans eligible for Veterans Health Administration care. Participants were randomly assigned (11) to receive SHUTi (a self-guided and interactive program) or an Insomnia Education Website (IEW) that provided nontailored and fixed insomnia information. Web-based assessments were administered at baseline, postintervention, 6 months postintervention, and 1 year postintervention. The primary outcome was self-reported insomnia severity (Insomnia Severity Index [ISI]). Secondary outcomes were self-reported mental and physical health functioning (Veterans RAND 36-item Health Survey). Exploratory outcomes comprised sleep diary parameters. RESULTS: Of the 231 randomized participants (mean age 39.3, SD 7.8 years; 170/231, 73.5% male sex; 26/231, 11.3% Black; 172/231, 74.5% White; 10/231, 4.3% multiracial; and 17/231, 7.4% other; 36/231, 15.6% Hispanic) randomized between April 2018 and January 2019, a total of 116 (50.2%) were randomly assigned to SHUTi and 115 (49.8%) to the IEW. In intent-to-treat analyses, SHUTi participants experienced significantly larger ISI decreases compared with IEW participants at all time points (generalized η2 values of 0.13, 0.12, and 0.10, respectively; all P<.0001). These corresponded to estimated larger differences in changes of -3.47 (95% CI -4.78 to -2.16), -3.80 (95% CI -5.34 to -2.27), and -3.42 (95% CI -4.97 to 1.88) points on the ISI for the SHUTi group. SHUTi participants experienced significant improvements in physical (6-month generalized η2=0.04; P=.004) and mental health functioning (6-month and 1-year generalized η2=0.04; P=.009 and P=.005, respectively). Significant sleep parameter improvements were noted for SHUTi (all P<.05), though the pattern and magnitude of these reductions varied by parameter. No adverse events were reported. CONCLUSIONS: Self-administered iCBT-I was associated with immediate and long-term improvements in insomnia severity. Findings suggest that leveraging technology to meet insomnia treatment demands among veterans may be a promising approach. TRIAL REGISTRATION ClinicalTrials.gov NCT03366870; https//clinicaltrials.gov/ct2/show/NCT03366870.