Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.
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2023-02
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Abstract
Background
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.Methods
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.Conclusion
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.Clinical trials
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NCT03727438.Type
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Ulmer, Christi S, Hayden B Bosworth, Jennifer Zervakis, Kaitlyn Goodwin, Pamela Gentry, Cynthia Rose, Amy S Jeffreys, Maren K Olsen, et al. (2023). Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. Contemporary clinical trials, 125. p. 107060. 10.1016/j.cct.2022.107060 Retrieved from https://hdl.handle.net/10161/27047.
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Christi S Ulmer
I am an Associate Professor at Duke University School of Medicine and clinical research psychologist at the Durham VA Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT). My research is focused on increasing our understanding of the health correlates of sleep disorders, increasing patient access to behavioral sleep medicine, and developing and disseminating behaviorally-based treatments for sleep disorders. I am a Behavioral Sleep Medicine Diplomate who has been treating patients with sleep disturbances for the past 17 years. I serve as faculty on the Durham VA Health Psychology fellowship training program; the first accredited BSM training program in the VA healthcare system. I served as a VA Co-Chair for the development of VA/DOD Clinical Practice Guidelines for insomnia and sleep apnea, and served as a consultant on the VA Dissemination of training in Cognitive Behavioral Therapy for Insomnia for more than 8 years. I am committed to expanding patient access to and provider knowledge of effective behavioral sleep medicine interventions, and increasing the recognition of sleep’s role in patient health.
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
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