ACTIVE_NOT_RECRUITING

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

Talk to us

Conditions

Insomnia DisorderPassive Body HeatingCognitive Behavioral Therapy for InsomniaCBT-IMood DisordersDigital Intervention

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 single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.

Official Title

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

Quick Facts

Study Start:2025-02-07
Study Completion:2026-01-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06626048

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. * Location to plug sauna blanket into regular wall outlet
  5. * Ability to lie in sauna blanket for 15 minutes
  6. * Ability to fit in the sauna blanket (no taller than 6' 3", no greater than 250 lbs)
  7. * Daily access to the internet via computer, smartphone, or tablet
  8. * Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI)
  9. * 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 worker
  2. * Current or planned routine body heating practices (e.g., saunas, hot tubs)
  3. * Pregnant or plans to become pregnant during the participation period
  4. * Other diagnosed sleep disorders or suspected sleep disorders
  5. * Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket
  6. * Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

University of California San Francisco
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 Date2025-02-07
Study Completion Date2026-01-28

Study Record Updates

Study Start Date2025-02-07
Study Completion Date2026-01-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Insomnia Disorder