Abstract
BackgroundInsomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC).Methods/DesignThe study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects.DiscussionThis randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions.Trial registrationClinicalTrials.gov (Identifier: NCT02508129; Date Registered: July 21, 2015).
Highlights
Insomnia is common in primary care medical practices
This study addresses a critical research gap related to insomnia treatment
While insomnia is one of the most common problems seen in primary care, safe and effective behavioral treatments for insomnia are not widely available
Summary
This study addresses a critical research gap related to insomnia treatment. While insomnia is one of the most common problems seen in primary care, safe and effective behavioral treatments for insomnia are not widely available. The aims focus on rigorously validated patient-reported outcome measures (e.g., PROMIS measures; Fig. 4), on health indicators (e.g., health-related quality of life, HBPM) relevant to patients and providers, and on healthcare utilization and cost data relevant to healthcare systems Many of these advantages reflect the pragmatic nature of the trial, as depicted in the PRECIS-2 radial graph (Fig. 4) and described above. Insomnia disorder is prevalent and important to patients, and has serious consequences and costs The strengths of this trial ensure that our research will have sustained impact on how sleep treatments are scaled and delivered in realworld clinical settings. Improving the sleep health of primary care patients could improve their overall health and represent a step toward improved population health [93] Trial status This trial remains ongoing with active recruitment at the time of manuscript submission.
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