Recovery Enhancement and Sleep Training

Anxiety Clinical Trial

— REST  

Official title:

Recovery Enhancement and Sleep Training (REST): Sleep and Mental Well-Being in Student Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982239
• Other study ID #: 1605615210
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 5, 2017

Study information

• Verified date: November 2016
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evidence suggests that student athletes frequently experience sleep problems and are aware of the impact of sleep loss on mental and physical outcomes. As such, student athletes are motivated to improve sleep quality in order to improve their outcomes for overall athletic performance. This study will consist of two parts. The first part will be a survey. Fall athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a survey within the first week of their arrival on campus. The survey will assess multiple domains of student-athlete health, namely, sleep duration and quality, mood and depression, stress, and mental and physical well-being. The responses to the survey will be confidential, and students will be compensated for the survey. At the end of the semester, students will be invited to complete the survey again.

Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the intervention, based on predetermined criteria. The intervention will include an information session where students may ask questions. Students will be sent text message reminders about adherence to the program and will be asked to monitor their sleep quality with sleep diaries. The intervention will consist of the half of the 40 chosen students, (20 students), who will be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit bit. Please note that all of these items are commercially available and are not meant to be used to treat or prevent human illness nor injury and do not require FDA oversight. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as well as adherence to the program.

Description:

Student athletes face many challenges to their ability to maintain healthy mental and physical well-being. The college experience is associated with a number of physiologic, social, and environmental stressors that can exert long-term effects on an individual's future health and quality of life. In addition, unique demands of student-athletes, including academic, physical performance, scheduling, and travel demands, all represent additional stressors that interact to produce in poorer outcomes.

Insufficient sleep duration and poor sleep quality have been increasingly identified as important risk factors for physical and mental well-being, especially among young adults. For example, insufficient and/or poor quality sleep is strongly associated with the development of cardiometabolic disease risk factors, obesity, depression, anxiety disorders, alcohol use, other substance use, poorer academic performance, and reduced mental well-being, in addition to poorer athletic performance.

Data from a recent PAC12 conference report shows that 2/3 of students indicated that lack of flexible time is the hardest thing about being an athlete, more than academic work. Further, students identified sleep as the first thing that their athletic time commitments kept them from doing, 77% felt that they got less sleep than non-athletes, and >50% indicated that they would use an extra hour to catch up on sleep. In 2015 data from the American College Health Association, (1) 29% of student athletes report significant sleep difficulties, (2) 40% reported getting enough sleep on only ≤3 nights, (3) 10% reported no problems with daytime sleepiness, (4) >15% reported sleepiness to be at least "a big problem," (5) >25% reported extreme difficulty falling asleep ≥3 nights/week (consistent with a diagnosis of insomnia), and (6) >50% reported that sleep problems impacted academic performance. Thus, student-athletes frequently experience sleep problems, they recognize the impact of sleep loss, and they are likely motivated to improve sleep. These data are consistent with data from professional athletes, whose overall sleep quality is poorer than non-athletes.

Taken together, sleep is an aspect of health that is implicated in many of the most salient mental and physical outcomes among college athletes. Despite this, obtaining sufficient sleep represents one of the greatest challenges facing student athletes. No programmatic approaches have been able to address this problem.

Accordingly, the proposed study aims to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes. This intervention will be assessed with and without the assistance of tools to aid in tracking sleep and adjusting to difficult schedules in order to evaluate the utility of those approaches.

The purpose of this research study is to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes.

Overall objectives AIM 1: Assess cross-sectional relationships among sleep, circadian preference, and outcomes including overall mental health, stress, mood, anxiety, social functioning, and physical well-being.

AIM 2: Determine whether a simple sleep health intervention, with and without the aid of technology, is associated with improvements in mental and physical well-being.

Primary outcome variable(s) AIM 1: depression score, stress score, mental well-being score, anxiety score, and physical well-being score AIM 2: changes in AIM 1 outcomes Secondary outcome variable(s) Academic stress, physical performance, substance use, health behaviors, soft tissue injuries, missed practices, academic performance

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 5, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willingness to participate

• Participation as a student-athlete during the entirety of their season

• No medical conditions that would preclude them from participating (assessed by self-report)

• Age =18 years

Exclusion Criteria:

• Freshmen

Related Conditions & MeSH terms

• Anxiety
• Mental Health
• Performance
• Sleep
• Stress

Intervention

Behavioral:
• Sleep Diary
All 40 chosen students will be provided a link to complete a daily sleep diary for 10 weeks. Sleep diary will assess activity before bed, bedtime, time to fall asleep, number of awakenings, time awake after sleep onset, time out of bed, time of final awakening, perceived sleep quality. Diary also asks about naps taken during the day, caffeine and tobacco consumption, and an additional space for open-ended comments from the participant.

Device:
• Fitness tracker
All 40 chosen students will receive a fitness tracker. The fit bit will estimate sleep and physical activity as well as adherence to the program. participants will have access to their own data. Data will also be monitored from the lab using Fitabase which provides access to day, hour, and minute-level resolution of data for steps taken, intensity class, calories burned, and sleep (length, movement, and quality).
• Blue-Blocking Glasses
Half of the 40 chosen students (N=20) will be provided with blue blocking glasses. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier.
• LED light
Half of the 40 chosen students (N=20) will be provided with a bright LED light. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes.

Other:
• Information Session
all 40 participants will attend a 1-hour information session about sleep delivered by the PIs, to be followed by a 1-hour Q&A period. Peer educators will receive and extra 1-hour training session on how to handle questions and when to refer back to the PIs.

Behavioral:
• Text messages
All participants will receive text messages in the evening that will include adherence reminders, encouraging statements, and tips for improving sleep. Messages will be randomized, with no more than 3 messages of any type per week. Messages will serve as a cue to action without being overly repetitive or predictable.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Collegiate Athletic Association - NCAA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index ( PSQI)	Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.	Change from baseline to post-intervention, around 10 weeks after baseline
Primary	Insomnia Severity Index (ISI)	Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)	Change from baseline to post intervention, around 10 weeks after baseline
Primary	Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)	Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.	Change from baseline to post intervention, around 10 weeks after baseline
Primary	Centers for Epidemiological Studies Depression Scale (CESD)	Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.	Change from baseline to post intervention, around 10 weeks after baseline
Primary	Perceived Stress Scale (PSS)	Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress.	Change from baseline to post intervention, around 10 weeks after baseline