Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study

University of California San Francisco (UCSF)

Status

Active, not recruiting

Conditions

Insomnia Disorder

Treatments

Behavioral: Cognitive Behavioral Therapy for Insomnia

Device: Passive Body Heating (PBH)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06626048

R34AT012767-01 (U.S. NIH Grant/Contract)

24-41821 A

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years or older
English-speaking
Willing to use birth control if assigned female sex at birth
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 (no taller than 6' 3", no greater than 250 lbs)
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)
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

Night shift worker
Current or planned routine body heating practices (e.g., saunas, hot tubs)
Pregnant or plans to become pregnant during the participation period
Other diagnosed sleep disorders or suspected sleep disorders
Medical conditions 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