Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
SLEEPS2
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedStudy Start
First participant enrolled
September 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
April 24, 2026
April 1, 2026
1.8 years
June 16, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intervention Acceptability
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).
9 weeks
Study Arms (2)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
ACTIVE COMPARATORParticipants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).
Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH)
EXPERIMENTALParticipants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.
Interventions
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) 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
You may qualify if:
- 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)
You may not qualify if:
- 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 between screening assessment and anticipated post-intervention assessment, or during anticipated post-follow-up assessment period (\~1 week)
- 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
- Currently receiving cognitive behavioral therapy for insomnia (CBT-I)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Osher Center for Integrative Health
San Francisco, California, 94115, United States
Related Publications (2)
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.
PMID: 31102877BACKGROUNDLee 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.
PMID: 36966184BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley E Mason, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The clinical outcomes assessor who conducts the post-treatment clinical interviews will be masked to study randomization.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2025
First Posted
June 25, 2025
Study Start
September 29, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months after the publication of results and unending.
- Access Criteria
- Data will be accessible via the Vivli platform. To access IPD arising from this project, users must complete the Vivli data request form and sign the Vivli Data Use Agreement, which limits subsequent use to the terms of the approved request and requires that users maintain data security, and refrain from any attempts to reidentify research participants or engage in any unauthorized uses of the data. In order to get access to the data, the user must submit a valid scientific question, include a statistical analysis plan, and complete all required fields on the Vivli data request form. Vivli will review the data request for completeness. Anyone who has submitted an approved data request and signed a data use agreement on Vivli will be given access to the data. Vivli will then make the data available, without cost, to users for a set period of time. Vivli will maintain storage and access of the data for as long as it maintains scientific utility.
The final IPD dataset will include self-reported demographic data, other self-reported data (e.g., subjective sleep measures, mood symptoms), and wearable-derived sleep data (wearable-derived sleep data will be shared as nightly aggregates).