Clinical trial NCT05576090: UCLA REST Study (REsearch on Sleep Techniques)
Official title: Mindful Awareness Practices Vs. Sleep Education: Improving Sleep Quality During the Transition to College
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Inflammation
Psychosocial Functioning
Keywords: Sleep
Adolescents
Mindfulness Meditation
Inflammation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Detailed description: Sleep disruption during college presents a significant public health concern, with studies documenting clinically-significant sleep disruption in 40-60% of college students. Poor sleep contributes to rising anxiety, depression, and loneliness as well as declining positive affect, motivation, and sense of purpose faced by many students as they attempt to navigate a successful path through college. Disrupted sleep also negatively impacts physical health, in part through up-regulating inflammatory processes that have acute and more chronic effects on a variety of health-related outcomes.

Overview: This single-site, two-arm, parallel group randomized controlled trial will evaluate the efficacy of a mindfulness-based intervention for sleep disturbance (Mindful Awareness Practices for Sleep (MAPs)) relative to an active sleep education control condition for first-year undergraduate students with sleep disturbance. Both interventions will be delivered in a group format once per week for six weeks, in the students' residential halls, and led by experienced instructors following manualized protocols. Groups will be conducted in the evenings at standardized times (weeks 3-8) during the 10-week quarter to avoid conflict with final exams. Assessments will be conducted pre- and post-intervention and at 3, 6, and 12-month post-intervention follow-ups to evaluate persistence of effects. All assessments will be conducted during the academic year.

Participants: Study participants will be first year undergraduate students at UCLA who endorse sleep disturbance as determined by a score of 8 or higher on the Insomnia Severity Index (ISI). They will be recruited in cohorts of 40-50 and randomized 1:1 to one of the two study arms (20-25 students per group, the optimal group size for the MAPs intervention). Participants will complete questionnaires and blood collection at in-person assessments conducted before and after the six-week intervention and at a 3-month post-intervention follow-up. Longer-term effects on self-reported outcomes will be assessed at 6- and 12-months post-intervention. Of note, the three follow-up assessments were scheduled to avoid the summer months given the focus on improving sleep in the college context.

Eligibility Screening: Potential participants will be directed to contact the study coordinator via email, phone, or a secure online signup form. The coordinator will then contact potential participants by phone to confirm eligibility criteria. The ISI will be administered to screen for current insomnia. Those who score an "8" or above, indicating at least sub-threshold levels of sleep disturbance, will be considered eligible for study participation. The 4-item Patient Health Questionnaire (PHQ4) survey will be used to screen for a diagnosis of a current mood or anxiety disorder. The 4-item PHQ-4 screening measure provides a good measure of "caseness" for both anxiety and depression that has been validated in college samples. If a potential subject scores a "3" on either subscale, the study coordinator will administer the 8-item Patient Health Questionnaire (PHQ8) for depression or the 7-item Generalized Anxiety Disorder (GAD-7) for anxiety, to determine the severity. If the potential participant scores "15" or more on either scale, they will be referred to the UCLA Counseling and Psychological Services (CAPS). Screening will continue until there are 45-50 participants who are eligible, interested, and available to participate in the next cohort.

Enrollment and Baseline Assessment (T1). All students who are determined to be eligible will be scheduled for an in-person, baseline assessment (T1) at the UCLA Health Psychology Laboratory (HPL). The Institutional Review Board (IRB) approved consent form will be reviewed and signed. A pre-intervention online survey will also be completed during this initial in-person visit. The survey will consist of the following scales: Background demographic and medical characteristics, health behaviors, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Anxiety and Preoccupation with Sleep (APSQ), Center for Epidemiological Studies-Depression (CES-D), Generalized Anxiety Disorder-7 (GAD-7), Multi-dimensional Fatigue Symptom Inventory Short Form (MFSI-SF), Perceived Stress Scale (PSS), UCLA Loneliness Scale, Positive and Negative Affect Scale (PANAS-X, positive affect subscales), Mental Health Continuum-Short Form (MHC-SF), Mindfulness scale (FFMQ), Self-Compassion Scale (self-kindness subscale), and the Rumination and Reflection Questionnaire (rumination subscale).

Participants will provide blood samples for immune evaluation using the Tasso OnDemand device, which allows self-collection of a single capillary blood sample and does not require venipuncture. The Tasso device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of the capillaries and into a sample pod attached to the bottom of the device. Participants will watch a demonstration video during their baseline assessment visit, and then use the device to collect a blood sample. Approximately 1/8th of a teaspoon of blood will be drawn at each in-person assessment.

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. They will be instructed to keep it on at all times, removing only for bathing. Participants will be instructed to press the event marker on the actigraph to indicate when they: 1) turn off the lights to go to sleep at night, 2) get out of bed in the middle of the night, such as to use the bathroom, 3) get out of bed in the morning, and 4) begin and end daytime naps. 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.

Assessments will be scheduled in the morning to control for diurnal variations in immune parameters. Baseline visits will be conducted in the 2-week period before intervention onset.

Randomization: Following baseline assessment, participants will be randomized to one of the two study conditions. Participants will be stratified based on gender (female/male/non-binary or other) and ISI score (less than 14/14 and above) and then randomized with 1:1 allocation to the two conditions. The randomization sequence will be generated using the PLAN procedure in SAS 9.4 and uploaded into REDCap. The study coordinator will use the REDCAP "Randomize" procedure to determine the participant's assigned condition. The coordinator will inform the participants of their assigned condition and provide information on the intervention.

Interventions: Both interventions will be held in private rooms in the residential part of the UCLA campus, close to student living quarters. Group sessions will be conducted in the evenings and scheduled to occur mid-way through the quarter (weeks 3-8 of the 10-week quarter) to minimize conflict with classes and exam periods.

Mindful Awareness Practices for Sleep (MAPs): Participants assigned to this condition will be asked to attend two-hour group sessions once a week for six weeks. The MAPs intervention is based on an institutional program developed by the Mindful Awareness Research Center (MARC) at UCLA and adapted to specifically address sleep disturbance. The MAPs program is similar to other mindfulness-based interventions in its general focus on cultivating mindfulness, but takes a more practical and accessible approach that focuses specifically on the practice of mindfulness and its application in everyday life (as compared to the focus on stress and stress reduction in mindfulness-based stress reduction). Key components of the intervention include development of bodily awareness, managing pain, working with difficult thoughts and feelings, cultivating positive emotions and loving kindness, and relational mindfulness practices. The MAPs curriculum will be implemented by trained instructors who will receive specialized training in delivery of the study-specific protocol and will be overseen by Diana Winston, Director of Education at the Mindful Awareness Research Center.

Sleep Education (SE): Participants assigned to this condition will be asked to attend a two-hour group session once a week for 6 weeks. This program is based on the sleep education program used by Dr. Michael Irwin and colleagues, and matches the MAPs condition for time, attention, group interaction, and expectancy of benefit. The SE 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).The standardized program will be implemented by trained health educators who will receive specialized training in delivery of the study-specific protocol with oversight by Co-I Dr. Michael Irwin.

Immediate Post-Intervention Assessment (T2): This in-person visit will be scheduled to occur within 2 weeks after the conclusion of the study interventions at the UCLA HPL and will include completion of study questionnaires, collection of blood samples, and 7 days of actigraphy.

3-, 6-, and 12-month Follow-up Assessments (T3,T4,T5). All participants will be asked to complete follow-up assessments at 3 months (T3), 6 months (T4), and 12 months (T5) post-intervention. The T3 assessment will be conducted at the UCLA HPL and will include completion of questionnaires, blood collection, and 7 days of actigraphy. T4 and T5 assessments will involve completion of online study questionnaires only (no blood draw or actigraphy). This assessment schedule will allow the investigators to capture short- and long-term effects.

Eligibility criteria: Inclusion Criteria:

* First or second year undergraduate student at UCLA
* Ages 18-20 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 \&#34;15\&#34; 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

Primary outcomes:
measure: Change in sleep quality from baseline to post-intervention on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
Secondary outcomes:
measure: Change in insomnia severity from baseline to post-intervention on the Insomnia Severity Index (ISI)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in actigraphy-based objective sleep measures from baseline to post-intervention.
timeFrame: Baseline and post-intervention; 3-month follow-up
measure: Change in depressive symptoms from baseline to post-intervention on the Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in anxiety from baseline to post-intervention on the Generalized Anxiety Disorder- 7 (GAD-7).
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in perceived stress from baseline to post-intervention on the Perceived Stress Scale (PSS).
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in loneliness from baseline to post-intervention on the UCLA Loneliness Scale
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in fatigue from baseline to post-intervention on the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general fatigue subscale.
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in positive affect from baseline to post-intervention on the Positive and Negative Affect Schedule (PANAS-X)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Changes in psychological well-being from baseline to post-intervention on the Mental Health Continuum-Short Form (MHC-SF)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Changes in inflammation from baseline to post-intervention
timeFrame: Baseline, at 8 weeks and at 20 weeks
measure: Change in worry about sleep from baseline to post-intervention on the Anxiety and Preoccupation with Sleep Questionnaire (APSQ)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in mindfulness from baseline to post-intervention on the 15-item Five Facet Mindfulness Questionnaire (FFMQ-15)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in self-kindness from baseline to post-intervention on the Self-Compassion Scale.
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
measure: Change in rumination from baseline to post-intervention on the Rumination and Reflection Questionnaire (RRQ)
timeFrame: Baseline and post-intervention; 3, 6, and 12-month follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Julienne E Bower, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Andrew Fuligni, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: