About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Insomnia (CBT-I)
BehavioralCognitive 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)
DevicePassive 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator