Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study

Not Applicable

Recruiting

• Conditions: Insomnia Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia; Device: Passive Body Heating (PBH)

• Registration Number: NCT06626048
• Lead Sponsor: University of California, San Francisco

Brief Summary

This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.

Detailed Description

Insomnia disorder is a common and consequential mental health problem, with prevalence estimates at approximately 10%. The American College of Physicians recommends cognitive behavioral therapy for insomnia (CBT-I), an efficacious "mind" (psychological and behavioral) treatment, as the first-line treatment for adults with insomnia. Yet, about half of individuals experience residual insomnia symptoms after CBT-I. Accordingly, researchers have sought to augment CBT-I, primarily with pharmacotherapy, but many people do not want to use pharmacologic agents due to concerns about side effects and dependence. Passive-body heating (PBH), a "body" treatment, involves heating the body via hot baths or showers, infrared sauna, or other heat sources. PBH has been found to reduce the time needed to fall asleep and to improve sleep quality. PBH may improve sleep by increasing skin temperature and decreasing core body temperature, a dynamic associated with sleep onset. CBT-I and PBH thus target distinct factors that may contribute to insomnia, and the investigators hypothesize that the combination of CBT-I and PBH holds promise as a multi-component treatment for insomnia disorder.

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Status Verified: 2025-02
• Study Start: 2025-02-07
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 18 years or older
• English-speaking
• Willing to use birth control if assigned female sex at birth
• Location to plug sauna blanket into regular wall outlet
• Ability to lie in sauna blanket for 15 minutes
• Ability to fit in the sauna blanket (no taller than 6' 3", no greater than 250 lbs)
• Daily access to the internet via computer, smartphone, or tablet
• Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI)
• Insomnia disorder (characterized by difficulty initiating sleep) as indexed by a positive diagnosis on the Structured Clinical Interview for DSM-5 Sleep Disorders (SCISD)

Exclusion Criteria

• Night shift worker
• Current or planned routine body heating practices (e.g., saunas, hot tubs)
• Pregnant or plans to become pregnant during the participation period
• Other diagnosed sleep disorders or suspected sleep disorders
• Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket
• Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH)	Cognitive Behavioral Therapy for Insomnia	Participants will receive both digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.
Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH)	Passive Body Heating (PBH)	Participants will receive both digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility	9 weeks	Proportion of eligible prospective participants who consent to complete at least 6 weeks of at least 3 PBH sessions per week over the 9-week intervention period.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States