RECRUITING

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

Talk to us

Conditions

Insomnia DisorderPassive Body HeatingCognitive Behavioral Therapy for InsomniaCBT-IDigital InterventionMood DisordersPBH

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-10
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07036705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * English-speaking
  3. * Willing to use birth control if assigned female sex at birth
  4. * Willing to receive study text messages during participation
  5. * Location to plug sauna blanket into regular wall outlet
  6. * Ability to lie in sauna blanket for 15 minutes
  7. * Ability to fit in the sauna blanket
  8. * Daily access to the internet via computer, smartphone, or tablet
  9. * Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI) at two screening timepoints
  10. * 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)
  1. * Night shift or swing shift worker
  2. * 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)
  3. * Pregnant or plans to become pregnant during the participation period
  4. * Traveling internationally in 16 weeks after taking 1st Study Screening Survey
  5. * Other diagnosed sleep disorders or suspected sleep disorders
  6. * Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket
  7. * Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction
  8. * Lifetime diagnosis of a bipolar disorder, psychosis, or other psychotic disorder
  9. * Current (past 3 months) major depressive disorder
  10. * 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
  11. * If using medications for mental health treatment (e.g., antidepressant medication) must have been on a stable dose for prior 8 weeks

Contacts and Locations

Study Contact

Study Team
CONTACT
415-514-8445
sleeps@ucsf.edu
Sarah M Fisher, MS
CONTACT
415-476-1218
sarah.fisher4@ucsf.edu

Principal Investigator

Ashley E Mason, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

Osher Center for Integrative Health
San Francisco, California, 94115
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Ashley E Mason, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-10
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Insomnia Disorder