Recruiting

Sleep Techniques

Sponsor:

UCLA

Code:

NCT05576090

Conditions

Sleep Disturbance

Inflammation

Psychosocial Functioning

Eligibility Criteria

Sex: All

Age: 18 - 22

Healthy Volunteers: Accepted

Interventions

Mindfulness Meditation

Sleep Education

Study Details

Brief summary:

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 and second 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.

Conditions

Sleep Disturbance

Inflammation

Psychosocial Functioning

Study ID

NCT05576090

Start date

Apr 3, 2023

Status verified date

Nov, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 22

Healthy Volunteers: Accepted

Inclusion Criteria:

  • First or second year undergraduate student at UCLA
  • Ages 18-22 years old
  • Must live in the residential halls on UCLA campus
  • Must have a score of 8 or above on the Insomnia Severity Index (ISI), indicating at least sub-threshold levels of sleep disturbance.

Exclusion Criteria

  • 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
  • Presence of medical conditions or use of medications that may influence sleep or inflammation (e.g., autoimmune disorder)
  • Previous or current formal instruction in mindfulness meditation (e.g., MAPs, MBSR) or current sleep education program

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness Meditation

Half of the subjects will be randomly assigned to participate in the Mindfulness Meditation intervention. This class will meet once a week, for two hours, over the course of six weeks.

active comparator: Sleep Education

Half of the subjects will be randomly assigned to participate in the Sleep Education intervention. This class will meet once a week, for two hours, over the course of six weeks.

Interventions

Mindfulness Meditation

The mindful awareness practices (MAPS) for Sleep intervention is based on an institutional program developed by the Mindful Awareness Research Center (MARC) at UCLA. This intervention includes educational and behavioral content related to sleep, including the importance of regularity of sleep schedules, minimizing noise and light, and reducing caffeine use later in the day. Each session provides structured training and exercises in mindfulness, including formal meditation practices and strategies for the daily informal use of mindfulness, as well as opportunity for questions and group discussion. Home practice is a key component of MAPs and is particularly important for addressing sleep disturbance. Participants will be instructed to practice mindfulness techniques on a daily basis, beginning with five minutes and increasing to 20 minutes, with practice prior to bedtime, and to practice at night if they awake and cannot return to sleep.

Sleep Education

The Sleep Education intervention provides education and behavioral content based on the National Institutes of Health and National Sleep Foundation tips for better sleep (e.g., changing poor sleep habits and establishing a bedtime routine). Each session provides didactic instruction, review of behavioral techniques, and opportunity for questions. Homework includes practicing sleep hygiene and weekly reading. Key components of the intervention include information about sleep biology, characteristics of healthy and unhealthy sleep, sleep problems, stress biology and stress reduction, self-monitoring of sleep behavior, relaxation methods for improving sleep, and weekly behavioral sleep hygiene strategies.

Primary outcome measure

  • Change in sleep quality from baseline to post-intervention on the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and post-intervention; 3, 6, and 12-month follow-up ]

Central Contacts and Locations

Central contacts

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

More Information

Sponsor

University of California, Los Angeles

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Sleep
  • Adolescents
  • Mindfulness Meditation
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-11-10.