Insomnia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
Osher Center for Integrative Health
RECRUITING
San Francisco
Contact Information
Primary
Study Team
sleeps@ucsf.edu
415-514-8445
Backup
Sarah M Fisher, MS
sarah.fisher4@ucsf.edu
415-476-1218
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2027-07
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov