Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Part of paid clinical trials in Portland, Oregon.

Sponsor
Kaiser Permanente
Study ID
NCT06067139
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • SHUTi — OTHER
    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.
  • Patient Education — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Dec 2025
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

2-hour post-load glucose (2hPG) (mg/dL) [ Time Frame: V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Center for Health ResearchPortlandOregon97227
Stefan Massimino, MS
[email protected]
971-232-9343
Chris Catlin
[email protected]
971-369-0655
Erin LeBlanc, MD (PRINCIPAL_INVESTIGATOR)
Greg Clarke, PhD (SUB_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Kaiser Permanente Center for Health Research· Portland, OR

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