Mindful Awareness Practices vs. Sleep Education: Improving Sleep Quality During the Transition to College
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in sleep quality from baseline to post-intervention on the Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
详细描述
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 and second-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 and second 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 22 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Change in sleep quality from baseline to post-intervention on the Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline and post-intervention; 3, 6, and 12-month follow-up
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.
次要结局
- Changes in psychological well-being from baseline to post-intervention on the Mental Health Continuum-Short Form (MHC-SF)(Baseline and post-intervention; 3, 6, and 12-month follow-up)
- 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 loneliness from baseline to post-intervention on the UCLA Loneliness Scale(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)
- Change in fatigue from baseline to post-intervention on the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general fatigue subscale.(Baseline and post-intervention; 3, 6, and 12-month follow-up)
- Changes in inflammation from baseline to post-intervention(Baseline, at 8 weeks and at 20 weeks)
- Change in actigraphy-based objective sleep measures from baseline to post-intervention.(Baseline and post-intervention; 3-month follow-up)
- Change in positive affect from baseline to post-intervention on the Positive and Negative Affect Schedule (PANAS-X)(Baseline and post-intervention; 3, 6, and 12-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 worry about sleep from baseline to post-intervention on the Anxiety and Preoccupation with Sleep Questionnaire (APSQ)(Baseline and post-intervention; 3, 6, and 12-month follow-up)
- Change in mindfulness from baseline to post-intervention on the 15-item Five Facet Mindfulness Questionnaire (FFMQ-15)(Baseline and post-intervention; 3, 6, and 12-month follow-up)
- Change in self-kindness from baseline to post-intervention on the Self-Compassion Scale.(Baseline and post-intervention; 3, 6, and 12-month follow-up)
- Change in rumination from baseline to post-intervention on the Rumination and Reflection Questionnaire (RRQ)(Baseline and post-intervention; 3, 6, and 12-month follow-up)
研究者
Julienne Bower, PhD
Professor
University of California, Los Angeles