JMIR Publications

ABSTRACT

Background:

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.

Objective:

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.

Methods:

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.

Results:

This study recruitment began in February 2019 and expected to be competed in September 2019.

Conclusions:

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. Clinical Trial: This study was registered in the Clinical Trials Registry (NCT03713996)