• Mohammed M Alshehri, Aqeel M Alenazi, Jeffrey C Hoover, Shaima A Alothman, Milind A Phadnis, Jason L Rucker, Christie A Befort, John M Miles, Patricia M Kluding, and Catherine F Siengsukon.
• University of Kansas Medical Center, Lenexa, KS, United States.
• JMIR Res Protoc. 2019 Dec 19; 8 (12): e14647.

BackgroundInsomnia symptoms are a common form of sleep difficulty among people with type 2 diabetes (T2D) affecting sleep quality and health outcomes. Several interventional approaches have been used to improve sleep outcomes in people with T2D. Nonpharmacological approaches, such as cognitive behavioral therapy for insomnia (CBT-I), show promising results regarding safety and sustainability of improvements, although CBT-I has not been examined in people with T2D. Promoting sleep for people with insomnia and T2D could improve insomnia severity and diabetes outcomes.ObjectiveThe objective of this study is to establish a protocol for a pilot randomized controlled trial (RCT) to examine the effect of 6 sessions of CBT-I on insomnia severity (primary outcome), sleep variability, and other health-related outcomes in individuals with T2D and insomnia symptoms.MethodsThis RCT will use random mixed block size randomization with stratification to assign 28 participants with T2D and insomnia symptoms to either a CBT-I group or a health education group. Outcomes including insomnia severity; sleep variability; diabetes self-care behavior (DSCB); glycemic control (A1c); glucose level; sleep quality; daytime sleepiness; and symptoms of depression, anxiety, and pain will be gathered before and after the 6-week intervention. Chi-square and independent t tests will be used to test for between-group differences at baseline. Independent t tests will be used to examine the effect of the CBT-I intervention on change score means for insomnia severity, sleep variability, DSCB, A1c, fatigue, sleep quality, daytime sleepiness, and severity of depression, anxiety, and pain. For all analyses, alpha level will be set at .05.ResultsThis study recruitment began in February 2019 and was completed in September 2019.ConclusionsThe intervention, including 6 sessions of CBT-I, will provide insight about its effect in improving insomnia symptoms, sleep variability, fatigue, and diabetes-related health outcomes in people with T2D and those with insomnia symptoms when compared with control.Trial RegistrationClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996.International Registered Report Identifier (Irrid)DERR1-10.2196/14647.©Mohammed M Alshehri, Aqeel M Alenazi, Jeffrey C Hoover, Shaima A Alothman, Milind A Phadnis, Jason L Rucker, Christie A Befort, John M Miles, Patricia M Kluding, Catherine F Siengsukon. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.12.2019.

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