UCLA REST Study (REsearch on Sleep Techniques)

NCT05576090 | Recruiting DMC

• 1 other identifier: 22-000229
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

Sleep; Adolescents; Mindfulness Meditation; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in sleep quality from baseline to post-intervention on the Pittsburgh Sleep Quality Index (PSQI)

  The PSQI includes 19 items, yielding seven dimensions of sleep: duration, disturbance, latency, daytime dysfunction, efficiency, quality, and sleeping medication use. Following standard procedure, we will obtain the PSQI global score by summing across all seven components. Each component has a maximum score of three points; the highest possible global score is 21. Higher PSQI global scores indicate poorer quality, with scores above 5 suggesting clinically-significant sleep disturbance. Our main analyses of the primary outcome will focus on the PSQI global score at post-intervention. Follow-up, exploratory analyses will examine whether observed effects are unique to any of the seven separate subscales of the PSQI, and whether there are intervention effects at the 3, 6, and 12-month post-intervention follow-ups.

  Baseline and post-intervention; 3, 6, and 12-month follow-up

Secondary Outcomes (14)

• Change in insomnia severity from baseline to post-intervention on the Insomnia Severity Index (ISI)

  Baseline and post-intervention; 3, 6, and 12-month follow-up

• Change in actigraphy-based objective sleep measures from baseline to post-intervention.

  Baseline and post-intervention; 3-month follow-up

• Change in depressive symptoms from baseline to post-intervention on the Center for Epidemiological Studies Depression Scale (CES-D)

  Baseline and post-intervention; 3, 6, and 12-month follow-up

• Change in anxiety from baseline to post-intervention on the Generalized Anxiety Disorder- 7 (GAD-7).

  Baseline and post-intervention; 3, 6, and 12-month follow-up

• Change in perceived stress from baseline to post-intervention on the Perceived Stress Scale (PSS).

  Baseline and post-intervention; 3, 6, and 12-month follow-up

Study Arms (2)

Mindfulness Meditation

EXPERIMENTAL

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.

Behavioral: Mindfulness Meditation

Sleep Education

ACTIVE COMPARATOR

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.

Behavioral: Sleep Education

Interventions

Mindfulness Meditation BEHAVIORAL

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.

Also known as: MAPS for Sleep Intervention

Mindfulness Meditation

Sleep Education BEHAVIORAL

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.

Sleep Education

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias; Inflammation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Julienne E Bower, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Andrew Fuligni, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah E Garet, MPH

CONTACT

(310) 975-9035; dgaret@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: April 3, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)