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

Author:

Nazem SarraORCID,Barnes Sean MORCID,Forster Jeri EORCID,Hostetter Trisha AORCID,Monteith Lindsey LORCID,Kramer Emily BORCID,Gaeddert Laurel AORCID,Brenner Lisa AORCID

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 (1:1) 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 η<sup>2</sup> values of 0.13, 0.12, and 0.10, respectively; all <i>P</i>&lt;.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 η<sup>2</sup>=0.04; <i>P</i>=.004) and mental health functioning (6-month and 1-year generalized η<sup>2</sup>=0.04; <i>P</i>=.009 and <i>P</i>=.005, respectively). Significant sleep parameter improvements were noted for SHUTi (all <i>P</i>&lt;.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.

CLINICALTRIAL

ClinicalTrials.gov NCT03366870; https://clinicaltrials.gov/ct2/show/NCT03366870

Publisher

JMIR Publications Inc.

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