Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans

Abstract

The goal of this study was to compare a brief behavioral treatment for insomnia (BBTI), which has fewer sessions (4), shorter duration (<30-45 minutes), and delivers treatment in-person plus phone calls to cognitive behavioral therapy for insomnia (CBTI), which has 5 in-person sessions. The hypothesis was BBTI would be noninferior to CBTI. The Reliable Change Index was used to establish a noninferiority margin (NIM) of 3.43, representing the maximum allowable difference between groups on the pre-post Insomnia Severity Index change (ΔISI). Sixty-three veterans with chronic insomnia were randomized to either BBTI or CBTI and veterans in both groups had significant reductions of their insomnia severity per the ISI and improved their sleep onset latency, total wake time, sleep efficiency, and sleep quality per sleep diaries. While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM. However, the 95% confidence interval of the between group pre-post ΔISI extended beyond the NIM, and thus BBTI was inconclusively noninferior to CBTI. Limitations, such as small sample size and high rate of dropout, indicate further study is needed to compare brief, alternative yet complementary behavioral insomnia interventions to CBTI. Still, evidence-based brief and flexible treatment options will help to further enhance access to care for veterans with chronic insomnia, especially in non-mental-health settings like primary care.

Trial registration: ClinicalTrials.gov NCT02724800.

Keywords: behavioral therapy; cognitive behavioral therapy; insomnia; noninferiority; veterans.

FIGURE 1

CONSORT flow chart

FIGURE 2

Baseline, treatment session, and posttreatment ISI for BBTI and CBTI