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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cognitive Behavioral Therapy for Insomnia (CBT-I)

    Behavioral

    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)

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Cognitive Behavioral Therapy for Insomnia (CBT-I)Active comparator 1 intervention
Group B: Cognitive Behavioral Therapy for Insomnia and Passive Body Heating (CBT-I+PBH)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Intervention Acceptability

Proportion of participants with a score of ≥7 on the following net promoter item: "How likely would you be to recommend participating in this study to a friend or family member with insomnia?" Responses range from "Would not recommend" (0) to "Would definitely recommend" (10).

Time frame
9 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator