An interventional study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) in Insomnia Disorder, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) · Device: Passive Body Heating (PBH)
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.
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).
Time frame: 9 weeks
Plan to share: Yes — 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).
Supporting information: Study protocol, Sap, Icf
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Sleep Initiation and Maintenance Disorders→
University of California, San Francisco