Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Kaiser Permanente
Summary
This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.
Description
Type 2 diabetes mellitus (T2D) is a major cause of blindness, kidney failure, cardiovascular disease, amputations, reduced quality of life, and premature death in the United States, and it is expected that one in three Americans will have T2D by 2050. To stem the tide of this health crisis, new strategies are needed to prevent the progression to T2D from prediabetes-elevated glucose levels that are not yet in the diabetes range. A growing body of research suggests that insomnia is a major modifiable risk factor for progression to diabetes. The proposed study would build off a promising feasibi…
Eligibility
- Age range
- 22–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 22 years and \< 80 years of age * Prediabetes * Insomnia * Regular access to device with internet access * Adequate data at baseline Exclusion Criteria: * BMI \> 40 kg/m2 * Sleep comorbidities detected in medical record or via medical history * Shift work or significant, externally imposed irregular sleep schedule * moderate to severe OSA by home sleep apnea test as part of trial protocol * Received a full course of CBT-I in the last 12 months * Current use of medication with glycemic effects: * History of type 1 or type 2 diabetes or recent/planned use of hypogl…
Interventions
- OtherSHUTi
Each core includes a variety of interactive features, such as animations, vignettes, "myth" and "reality" buttons that reveal common misperceptions and facts about sleep, "learn more" buttons that provide in-depth information about a topic, and quizzes. All cores follow a similar structure with objectives, main content, homework, and review. Participants are free to revisit cores as many times as they like.
- OtherPatient Education
The PE website will present content in a simple, static form, without interactive components; and all content on the website will be provided at once, rather than in modules that unlock over time. The PE website will also not provide personalized or individually tailored treatment recommendations.
Location
- Kaiser Permanente Center for Health ResearchPortland, Oregon