Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 79
Healthy Volunteers: f
View:
• Age ≥ 22 years and \< 80 years of age
• Prediabetes
• Insomnia
• Regular access to device with internet access
• Adequate data at baseline
Locations
United States
Oregon
Kaiser Permanente Center for Health Research
RECRUITING
Portland
Contact Information
Primary
Stefan Massimino, MS
stefan.massimino@kpchr.org
971-232-9343
Backup
Chris Catlin
chris.l.catlin@kpchr.org
971-369-0655
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 300
Treatments
Experimental: Digital cognitive behavioral therapy (dCBT-I)
CBT-I is designed to change sleep habits and scheduling factors that affect sleep, and to address misconceptions about sleep and insomnia that perpetuate sleep difficulties. The investigators will employ SHUTi, which is an extensively studied dCBT-I program. SHUTi is intended to improve insomnia symptoms by providing neurobehavioral intervention (cognitive behavioral therapy for insomnia - CBT-I) in adults with chronic insomnia. It is a six-core internet-delivered CBT-I web-based app that is run through a browser. It is accessible via iPhone/iPad, Android phone/tablet, computer or laptop (any device with a browser). SHUTi follows evidence-based CBT-I principles.
Active_comparator: Patient Education (PE)
Participants will be given access to a patient education website. It will provide nontailored material about insomnia symptoms; the impact, prevalence, and causes of insomnia; and basic lifestyle, environmental, and behavioral strategies to improve sleep.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Kaiser Permanente