Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2

Not Applicable

Not yet recruiting

• Conditions: Insomnia Disorder

• Registration Number: NCT07036705
• Lead Sponsor: University of California, San Francisco

Brief Summary

This two-arm randomized trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) to all participants and passive body heating (PBH) sessions using a sauna blanket to half of participants over a 9-week treatment period. Participants are 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

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-27
• Study Start: 2025-11-01
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 years or older
• English-speaking
• Willing to use birth control if assigned female sex at birth
• Willing to receive study text messages during participation
• 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
• 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) at two screening timepoints
• Primary 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 or swing shift worker
• Current or planned routine body heating practices (e.g., saunas, hot tubs, long baths) within 4 hours before bed that are 10 minutes or more in duration (≥2x per week)
• Pregnant or plans to become pregnant during the participation period
• Traveling internationally in 16 weeks after taking 1st Study Screening Survey
• 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
• Lifetime diagnosis of a bipolar disorder, psychosis, or other psychotic disorder
• Current (past 3 months) major depressive disorder
• Current (past 12 months) suicidality, alcohol use disorder, other substance use disorder (except mild cannabis use disorder), panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, post-traumatic stress disorder, and eating disorders
• If using medications for mental health treatment (e.g., antidepressant medication) must have been on a stable dose for prior 8 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention Acceptability	9 weeks	Proportion of participants with a score of ≥7 on the following net promoter item: "How likely would you be to recommend participating in this study to a friend or family member with insomnia?" Responses range from "Would not recommend" (0) to "Would definitely recommend" (10).

Trial Locations

Locations (1)

Osher Center for Integrative Health; 🇺🇸 San Francisco, California, United States