Currently submitted to: JMIR Research Protocols
Date Submitted: May 8, 2019
Open Peer Review Period: May 13, 2019 - May 27, 2019
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The Effect of Cognitive Behavioral Therapy for Insomnia on Individuals with Type 2 Diabetes and Insomnia Symptoms: A Protocol for a Randomized Controlled Trial
Insomnia symptoms are a common form of sleep difficulties 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. Non-pharmacological 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.
The purpose of this study is to establish a protocol for a study to examine the effect of 6 sessions of CBT-I on insomnia severity, sleep variability, and other health-related outcomes in individuals with insomnia symptoms and T2D.
This randomized controlled trial will use random mixed block size randomization with stratification to assign 28 participants to either a CBT-I group or a Health Education group. Chi-square and independent t tests will be used to test for between-group differences at baseline. Independent t tests will examine the effect of the CBT-I intervention on change score means for the Insomnia Severity Index, diabetes self-care behaviors, glycemic control, fatigue, sleep quality, and daytime sleepiness. Mixed models will be used to compare the difference in sleep variability between the CBT-I group and the Health Education group. Finally, a completer vs non-completer analysis will be performed. For all analyses, alpha level will be set at 0.05.
This study recruitment began in February 2019 and expected to be competed in September 2019.
The intervention included 6 sessions of CBT-I will provide insight about its effect in improving insomnia symptoms, sleep variability, fatigue, and diabetes outcomes in people with insomnia symptoms and T2D when compared to control.
This study was registered in the Clinical Trials Registry (NCT03713996)
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