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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

1
Osher Center for Integrative Health94115, San FranciscoCalifornia, United States

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator