RECRUITING

UCLA REST Study (REsearch on Sleep Techniques)

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

Sleep disturbance has a range of negative effects on psychosocial and biological processes important for academic and social success as well as mental and physical health among adolescents and young adults. Limited, inconsistent, and poor quality sleep lead to anxiety, depressive feelings, loneliness, and fatigue over time. These symptoms, in turn, interfere with the ability to get a good night's rest. Sleep disruption can also upregulate inflammatory processes during the years of adolescence and young adulthood in ways that can create risk for the development of chronic health conditions (e.g., diabetes, depression, cardiovascular disease) in later adulthood. Sleep, however, is also a modifiable health behavior, leading many institutions to embark upon efforts to improve the sleep of their students. The challenge is to identify programs and interventions that can simultaneously improve sleep, be delivered at scale, and be easily completed by students. UCLA has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on sleep in adults and may offer a promising, scalable approach for reducing sleep disturbance and improving associated psychological and biological outcomes in college students. However, this approach requires validation in this population relative to sleep education programs, which increasingly dominate the college landscape. To address this important public health problem, the investigators propose to conduct a single site, two-arm, parallel group randomized controlled trial to test the efficacy of the validated, group-based, six-week MAPs intervention vs. sleep education, an active time and attention matched control condition, for first year undergraduate students who report poor sleep at this critical transition year. The investigators are aiming to enroll approximately 240 participants. Participants will complete questionnaires, provide blood samples for immune analysis and will be provided with wrist actigraphs to wear for 7 days, in order to collect objective measurements of sleep at pre- and post-intervention visits, and at a 3-month follow-up visit. Additional follow-up assessments will take place at 6-month, and 12-month post-intervention to evaluate persistence of effects.

Official Title

Mindful Awareness Practices Vs. Sleep Education: Improving Sleep Quality During the Transition to College

Quick Facts

Study Start:2023-04-03
Study Completion:2027-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05576090

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 to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * First or second year undergraduate student at UCLA
  2. * Ages 18-20 years old
  3. * Must live in the residential halls on UCLA campus
  4. * Must have a score of 8 or above on the Insomnia Severity Index (ISI), indicating at least sub-threshold levels of sleep disturbance.
  5. * Current diagnosis of mood or anxiety disorder as determined by the PHQ-8 or by the GAD-7 if score \"15\" or more on either measure
  6. * Presence of medical conditions or use of medications that may influence sleep or inflammation (e.g., autoimmune disorder)
  7. * Previous or current formal instruction in mindfulness meditation (e.g., MAPs, MBSR) or current sleep education program
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Deborah E Garet, MPH
CONTACT
(310) 975-9035
dgaret@mednet.ucla.edu

Principal Investigator

Julienne E Bower, Ph.D.
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Andrew Fuligni, Ph.D.
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Julienne E Bower, Ph.D., PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Andrew Fuligni, Ph.D., PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

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 Date2023-04-03
Study Completion Date2027-05-30

Study Record Updates

Study Start Date2023-04-03
Study Completion Date2027-05-30

Terms related to this study

Keywords Provided by Researchers

  • Sleep
  • Adolescents
  • Mindfulness Meditation
  • Inflammation

Additional Relevant MeSH Terms

  • Sleep Disturbance
  • Inflammation
  • Psychosocial Functioning