Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial

• Published in: Contemporary clinical trials 2023-02, Vol.125, p.107060-107060, Article 107060
• Main Authors: Ulmer, Christi S., Bosworth, Hayden B., Zervakis, Jennifer, Goodwin, Kaitlyn, Gentry, Pamela, Rose, Cynthia, Jeffreys, Amy S., Olsen, Maren K, Weidenbacher, Hollis J., Beckham, Jean C., Voils, Corrine I.
• Format: Article
• Language: English
• Subjects: Actigraphy; Behavioral sleep medicine; Cognitive Behavioral Therapy - methods; Cognitive behavioral therapy for insomnia (CBTi); Humans; Insomnia; Quality of Life; Randomized Controlled Trials as Topic; Self-Management; Sleep; Sleep Initiation and Maintenance Disorders - therapy; Treatment Outcome; Veterans
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2022.107060

Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. NCT03727438