UCLA REST Study (REsearch on Sleep Techniques)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-22
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Meditation
BehavioralThe 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
BehavioralThe 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Mindfulness MeditationExperimental treatment 1 intervention
Group B: Sleep EducationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and post-intervention; 3, 6, and 12-month follow-upSecondary outcomes
1
Change in insomnia severity from baseline to post-intervention on the Insomnia Severity Index (ISI)
The ISI consists of 7 items which are summed for a total score (range: 0-28) with higher scores indicating greater insomnia severity. Scores of 8-14 indicate subthreshold insomnia, while scores of 15-28 indicate clinical insomnia.
Time frame
Baseline and post-intervention; 3, 6, and 12-month follow-up2
Change in actigraphy-based objective sleep measures from baseline to post-intervention.
We will obtain objective estimates of sleep using wrist actigraphy. At the baseline assessment prior to randomization (T1) and at T2 and T3, participants will be provided with a wrist actigraph (Micro Motionlogger Sleep Watch, Ambulatory Monitoring, Inc.; Ardsley, NY) to wear on their non-dominant hand for seven consecutive 24-hour periods. The software package Action 4 (Ambulatory Monitoring, Inc.; Ardsley, NY) will be used to code and score the actigraphy data, and established algorithms will be used to provide estimates of parameters such as sleep duration, sleep onset latency, efficiency, daily variability, and wakenings after sleep onset.
Time frame
Baseline and post-intervention; 3-month follow-up3
Change in depressive symptoms from baseline to post-intervention on the Center for Epidemiological Studies Depression Scale (CES-D)
The 20-item CES-D is a measure of depression symptom severity, with higher scores (range: 0-60) indicating greater depressive symptoms
Time frame
Baseline and post-intervention; 3, 6, and 12-month follow-up4
Change in anxiety from baseline to post-intervention on the Generalized Anxiety Disorder- 7 (GAD-7).
Symptoms of anxiety will be measured via the 7-item GAD-7. Higher scores (range: 0-21) indicate greater severity of symptoms
Time frame
Baseline and post-intervention; 3, 6, and 12-month follow-upSponsors and contacts
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Source ClinicalTrials.gov