Clinical trial NCT04311372: Sleep Wellness Program - University REST
Official title: Sleep Wellness Program - University REST
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poor Quality Sleep
Sleep Disturbance
Keywords: Mental Health
College Students
Sleep
Educational Intervention
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: N=100 participants will be randomized to one of two groups.

Group 1 \| n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)

Group 2 \| n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
Primary purpose: BASIC_SCIENCE

Brief summary: This study study aims to examine relationships between sleep and mental health and well-being among a more heterogeneous sample of students and apply the REST intervention to this group to determine whether we can improve sleep in this group and whether changes in sleep are associated with improvements in mental health.

Detailed description: Poor mental health is a major problem among college students. Data from the World Health Organization (WHO) reports that 20% of college students likely meet criteria for a mental health condition, yet only approximately 16% of those with conditions received treatment. Data from the 2015 National College Health Assessment (N=67,308 from 108 colleges/universities) showed that 25% of the sample had a diagnostic history of a psychiatric condition. Further, this study found high rates of the presence of mental health symptoms in the past 12 months among students, with 35% reporting depression that interfered with functioning, 39% reporting overwhelming anger, 50% reporting hopelessness, 58% reporting overwhelming anxiety, 61% reporting loneliness, 66% reporting feeling very sad, 83% reporting exhaustion, and 87% reporting feeling overwhelmed. Self-harm was reported by 7% and 10% reported that they "seriously considered suicide."

Many previous studies have shown that sleep is strongly related to mental health, especially among your adults. In particular, our preliminary data from the 2011-2014 National College Health Assessment data show that each night of reported insufficient sleep was associated with an increased likelihood of also reporting hopelessness (28% increase per night of insufficient sleep), feeling overwhelmed (24%), exhaustion (31%), loneliness (21%), sadness (21%), functional problems (30%), anxiety (28%), anger (27%), desire to hurt self (21%), suicide ideation (30%), and suicide attempts (12%). In looking at UA students, we previously found that among student athletes, sleep is related to mental health. Sleep duration, sleep quality, insomnia, fatigue, and symptoms of sleep disordered breathing were all independently associated with depression, anxiety, and mental well-being.

In our previous work, we developed an intervention called "REST" (Recovery Enhancement and Seep Training) that was deployed among student athletes. This intervention included education, sleep tracking, a financial incentive (lottery system), and support. It was effective at increasing sleep duration (by M=77 mins) and improving sleep quality (increased sleep efficiency, reduced insomnia severity, and reduced fatigue). The present study aims to examine relationships between sleep and mental health and well-being among a more heterogeneous sample of students and apply the REST intervention to this group to determine whether we can improve sleep in this group and whether changes in sleep are associated with improvements in mental health.

Eligibility criteria: Inclusion Criteria:

* at least a score of 3 on the Pittsburgh Sleep Quality Index (indicating at least a minor problem with sleep quality).
* a score of at least 6 on the Epworth Sleepiness Scale (indicating at least moderate sleepiness).
* a score of at least 7 on the Insomnia Severity Index (indicating at least mild insomnia), or habitual sleep duration of less than 6 hours per night (indicating insufficient sleep).

Exclusion Criteria:

* score less than a 3 on the Pittsburgh Sleep Quality Index.
* score less than a 6 on the Epworth Sleepiness Scale.
* score less than a 7 on the Insomnia Severity Index.

Primary outcomes:
measure: Changes in Insomnia Severity Index (ISI)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in the Fatigue Severity Scale (FSS)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in the Epworth Sleepiness Scale (ESS)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in the Assessment of Sleep Environment (ASE)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in the Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in Generalized Anxiety Disorder (GAD-7)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Changes in Perceived Stress Scale (PSS)
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
Secondary outcomes:
measure: National College Health Assessment (NCHA) Mental Health Item
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: Columbia Suicide Severity Rating Scale
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
measure: World Health Organization (WHO) Performance Questionnaire Item A9
timeFrame: Change from baseline to post-intervention, around 8 weeks after baseline
Other outcomes:
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