Recruiting

CBT-I & PBH

Sponsor:

UCLA

Code:

NCT07036705

Conditions

Insomnia Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Passive Body Heating (PBH)

Study Details

Brief summary:

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.

Conditions

Insomnia Disorder

Study ID

NCT07036705

Start date

Sep 29, 2025

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

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

Interventions

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.

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 measure

  • Intervention Acceptability [ Time Frame: 9 weeks ]

Central Contacts and Locations

Central contacts

Study Team

415-514-8445sleeps@ucsf.edu

Sarah M Fisher, MS

415-476-1218sarah.fisher4@ucsf.edu

Locations

Osher Center for Integrative Health

Recruiting

San Francisco, California, United States, 94115

Contacts

Sarah M Fisher, MS

415-476-1218sleeps@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Passive Body Heating
  • Cognitive Behavioral Therapy for Insomnia
  • CBT-I
  • Insomnia Disorder
  • Digital Intervention
  • Mood Disorders
  • PBH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.