Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
NCT ID: NCT07036705
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-29
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Behavioral Therapy for Insomnia (CBT-I)
Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cognitive behavioral therapy for insomnia (CBT-I) is a behavioral (psychotherapeutic) intervention for insomnia disorder. Participants will complete digital CBT-I online using the Sleep Healthy Using the Internet (SHUTi) program.
Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH)
Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cognitive behavioral therapy for insomnia (CBT-I) is a behavioral (psychotherapeutic) intervention for insomnia disorder. Participants will complete digital CBT-I online using the Sleep Healthy Using the Internet (SHUTi) program.
Passive Body Heating (PBH)
Passive body heating (PBH) is a body-based treatment that participants will complete using a sauna blanket, which is similar in form factor to an adult-sized sleeping bag (head is not within the heated area). Participants will complete at least three 15-minute PBH sessions per week. Participants will complete PBH sessions in the sauna blanket placed on the floor or on a couch (i.e., not in their bed) at a setting of Level 6, 1-2 hours before bed.
Interventions
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Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cognitive behavioral therapy for insomnia (CBT-I) is a behavioral (psychotherapeutic) intervention for insomnia disorder. Participants will complete digital CBT-I online using the Sleep Healthy Using the Internet (SHUTi) program.
Passive Body Heating (PBH)
Passive body heating (PBH) is a body-based treatment that participants will complete using a sauna blanket, which is similar in form factor to an adult-sized sleeping bag (head is not within the heated area). Participants will complete at least three 15-minute PBH sessions per week. Participants will complete PBH sessions in the sauna blanket placed on the floor or on a couch (i.e., not in their bed) at a setting of Level 6, 1-2 hours before bed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Medication use 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
* Medical condition 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Ashley E Mason, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Osher Center for Integrative Health
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Sarah M Fisher, MS
Role: primary
References
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Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Before-bedtime passive body heating by warm shower or bath to improve sleep: A systematic review and meta-analysis. Sleep Med Rev. 2019 Aug;46:124-135. doi: 10.1016/j.smrv.2019.04.008. Epub 2019 Apr 19.
Lee S, Oh JW, Park KM, Lee S, Lee E. Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. NPJ Digit Med. 2023 Mar 25;6(1):52. doi: 10.1038/s41746-023-00800-3.
Related Links
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Research Studies Home Page to Access Online Study Screener Survey
Other Identifiers
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24-41821 B
Identifier Type: -
Identifier Source: org_study_id