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

Overview

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.

Detailed 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.

Interventions

• Behavioral Cognitive Behavioral Therapy for Insomnia (CBT-I)
  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.
• Device Passive Body Heating (PBH)
  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.

Primary outcome measures

• Intervention Acceptability [Time frame: 9 weeks]

Eligibility criteria

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
• Currently receiving cognitive behavioral therapy for insomnia (CBT-I)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Osher Center for Integrative Health — San Francisco

Publications

• Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Before-bedtime passive body heating by warm shower or bath to improve sleep: A systematic review and meta-analysis. Sleep Med Rev. 2019 Aug;46:124-135. doi: 10.1016/j.smrv.2019.04.008. Epub 2019 Apr 19. PMID 31102877
• Lee S, Oh JW, Park KM, Lee S, Lee E. Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. NPJ Digit Med. 2023 Mar 25;6(1):52. doi: 10.1038/s41746-023-00800-3. PMID 36966184

Identifiers

NCT: NCT07036705 · 24-41821 B · R34AT012767-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗