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Recovery Enhancement and Sleep Training

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02982239
Acronym
REST
Enrollment
40
Registered
2016-12-05
Start date
2016-06-30
Completion date
2017-01-05
Last updated
2019-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep, Performance, Mental Health, Stress, Anxiety

Brief 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.

Detailed 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

Interventions

BEHAVIORALSleep 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.

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).

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.

DEVICELED 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.

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.

BEHAVIORALText 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.

Sponsors

National Collegiate Athletic Association - NCAA
CollaboratorUNKNOWN
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index ( PSQI)Change from baseline to post-intervention, around 10 weeks after baselineChange 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.
Insomnia Severity Index (ISI)Change from baseline to post intervention, around 10 weeks after baselineChange 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)
Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)Change from baseline to post intervention, around 10 weeks after baselineChange 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.
Centers for Epidemiological Studies Depression Scale (CESD)Change from baseline to post intervention, around 10 weeks after baselineChange 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.
Perceived Stress Scale (PSS)Change from baseline to post intervention, around 10 weeks after baselineChange 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.

Participant flow

Recruitment details

Student-athletes were recruited over the summer and through the first 2 weeks of the 2015 Fall semester, as they arrived on campus. Recruitment was accomplished through flyers, referrals from athletics staff, and in-person recruitment among athletes at on campus athletic facilities.

Pre-assignment details

All students who completed the survey were eligible for the intervention study, though selection was targeted to those with sleep complaints.

Participants by arm

ArmCount
Intervention
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
20
Intervention -Tech
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
20
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up32

Baseline characteristics

CharacteristicInterventionIntervention -TechTotal
Age, Continuous20.56 years
STANDARD_DEVIATION 0.97
20.55 years
STANDARD_DEVIATION 0.93
20.55 years
STANDARD_DEVIATION 0.94
Sex: Female, Male
Female
14 Participants13 Participants27 Participants
Sex: Female, Male
Male
6 Participants7 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

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.

Time frame: Change from baseline to post intervention, around 10 weeks after baseline

ArmMeasureGroupValue (MEAN)Dispersion
InterventionCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy Physical health days Baseline5.411764706 Days out of 30Standard Deviation 9.695738906
InterventionCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy mental health days Baseline6.176470588 Days out of 30Standard Deviation 10.30919065
InterventionCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy mental health days Post-Intervention6.411764706 Days out of 30Standard Deviation 8.000459546
InterventionCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy physical health days Post-Intervention6.352941176 Days out of 30Standard Deviation 9.512762325
Intervention -TechCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy physical health days Post-Intervention6.833333333 Days out of 30Standard Deviation 9.173170598
Intervention -TechCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy Physical health days Baseline3.944444444 Days out of 30Standard Deviation 6.803737919
Intervention -TechCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy mental health days Post-Intervention4.611111111 Days out of 30Standard Deviation 5.699730529
Intervention -TechCenters for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)unhealthy mental health days Baseline7.555555556 Days out of 30Standard Deviation 8.958874813
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.

Time frame: Change from baseline to post intervention, around 10 weeks after baseline

ArmMeasureGroupValue (MEAN)Dispersion
InterventionCenters for Epidemiological Studies Depression Scale (CESD)CESD total score Baseline8.294117647 score on a scaleStandard Deviation 6.45914764
InterventionCenters for Epidemiological Studies Depression Scale (CESD)CESD total score Post-Intervention9.470588235 score on a scaleStandard Deviation 8.147987843
Intervention -TechCenters for Epidemiological Studies Depression Scale (CESD)CESD total score Baseline10.16666667 score on a scaleStandard Deviation 7.957608272
Intervention -TechCenters for Epidemiological Studies Depression Scale (CESD)CESD total score Post-Intervention7.333333333 score on a scaleStandard Deviation 6.962082177
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)

Time frame: Change from baseline to post intervention, around 10 weeks after baseline

ArmMeasureGroupValue (MEAN)Dispersion
InterventionInsomnia Severity Index (ISI)Baseline5.529411765 scores on a scaleStandard Deviation 4.862068066
InterventionInsomnia Severity Index (ISI)Post-intervention5.176470588 scores on a scaleStandard Deviation 4.034775305
Intervention -TechInsomnia Severity Index (ISI)Baseline7.5 scores on a scaleStandard Deviation 3.944467458
Intervention -TechInsomnia Severity Index (ISI)Post-intervention5.266666667 scores on a scaleStandard Deviation 3.954503159
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.

Time frame: Change from baseline to post intervention, around 10 weeks after baseline

ArmMeasureGroupValue (MEAN)Dispersion
InterventionPerceived Stress Scale (PSS)Baseline21.52941176 score on a scaleStandard Deviation 7.072107598
InterventionPerceived Stress Scale (PSS)Post-intervention23.05882353 score on a scaleStandard Deviation 7.386394488
Intervention -TechPerceived Stress Scale (PSS)Baseline21.27777778 score on a scaleStandard Deviation 5.706606652
Intervention -TechPerceived Stress Scale (PSS)Post-intervention19.11111111 score on a scaleStandard Deviation 7.379533613
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.

Time frame: Change from baseline to post-intervention, around 10 weeks after baseline

ArmMeasureGroupValue (MEAN)Dispersion
InterventionPittsburgh Sleep Quality Index ( PSQI)Baseline4.941176471 units on a scaleStandard Deviation 2.9041046
InterventionPittsburgh Sleep Quality Index ( PSQI)Post-intervention4.647058824 units on a scaleStandard Deviation 2.84914848
Intervention -TechPittsburgh Sleep Quality Index ( PSQI)Baseline6.555555556 units on a scaleStandard Deviation 3.329409455
Intervention -TechPittsburgh Sleep Quality Index ( PSQI)Post-intervention5.833333333 units on a scaleStandard Deviation 2.7917947

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026