University of California San Francisco
San Francisco, California, 94115, United States
NCT Number: NCT06626048
This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Digital 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.
Time frame: 9 weeks
Proportion of eligible prospective participants who consent to complete at least 6 weeks of at least 3 PBH sessions per week over the 9-week intervention period.
University of California, San Francisco
Other
Acronym: SLEEPS
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