Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2 (SLEEPS2)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Insomnia Disorder

Treatments: Device: Passive Body Heating (PBH); Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07036705

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

24-41821 B

Details and patient eligibility

About

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.

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: 40 estimated 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
• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Active Comparator group

Description:

Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I).

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH)

Experimental group

Description:

Participants will receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Device: Passive Body Heating (PBH)