Sleep Wellness Program - University REST

Sleep Disturbance Clinical Trial

Official title:

Sleep Wellness Program - University REST

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04311372
• Other study ID #: TBD3
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2020
• Source: University of Arizona
• Contact: Michael A Grandner, PhD, MTR
• Phone: 5206266346
• Email: grandner[@]email.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Poor Quality Sleep
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Behavioral:
• Educational Sesssion+Material+Videos
n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
• Educational Sesssion+Material ONLY
n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Insomnia Severity Index (ISI)	The Insomnia Severity Index is a brief screening assessment tool designed to evaluate insomnia. Time frame: past 2 weeks. Measuring 7 items. Scores range from 0-28. Scores interpret as follow: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). The higher the result, the more severe the insomnia is.	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in the Pittsburgh Sleep Quality Index (PSQI)	A subjective measure of sleep. Score ranges from 0-21. Higher scores indicate worse sleep quality.	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in the Fatigue Severity Scale (FSS)	The Fatigue Severity Scale is a self-reported scale measuring fatigue. Time frame: previous week. Measuring 9 items. Scores ranges from 9-63. Levels of fatigue interpret as follow: not suffering from fatigue (<36); presence of fatigue (>36). The higher the score, the greater fatigue is perceived.	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in the Epworth Sleepiness Scale (ESS)	The Epworth Sleepiness Scale is a self-administered questionnaire that's routinely used to assess daytime sleepiness. Time frame: previous 2 weeks. Measuring 8 items. Score ranges from 0-24. The higher the score, the higher average sleep propensity in daily life (ASP) or daytime sleepiness is.	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in the Assessment of Sleep Environment (ASE)	A questionnaire that measures the degree to which the physical environment disturbs sleep. It contains 13 items with scores ranging from 0-Strongly Disagree to 3-Strongly Agree. Higher scores suggest less optimal sleep environment.	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in the Center for Epidemiologic Studies Depression Scale (CES-D)	A short self-report scale designed to measure depressive symptomatology. Time frame: previous week. Measuring 20 items comprising 6 scales. Score ranges from 0-60. The higher the score is the greater the presence of depressive symptomatology.	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in the Patient Health Questionnaire (PHQ-9)	A self-administered questionnaire for common mental disorders, specifically in to the depression module. Time frame: past 2 weeks. Measuring 9 items. Scores ranges from 0-27. Levels of depression measure as follow: minimal (0-4); mild (5-9); moderate (10-14); moderately severe (15-19); severe (20-27).	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in Generalized Anxiety Disorder (GAD-7)	A brief self-report scale to identify probable cases of generalized anxiety. Time frame: past 2 weeks. Measuring 7 items. Scores ranges from 0-21. Levels of anxiety measure as follow: mild (0-9); moderate (10-14); severe (>15). The higher the score the greater presence of generalized anxiety.	Change from baseline to post-intervention, around 8 weeks after baseline
Primary	Changes in Perceived Stress Scale (PSS)	A subjective scale measuring perceived stress. Measuring 10 items. Time frame: previous month. Score ranges from 0-40. Levels of stress measure as follow: low stress (0-13); moderate stress (14-26); high perceived stress (27-40). The higher the score, the greater stress is perceived.	Change from baseline to post-intervention, around 8 weeks after baseline
Secondary	National College Health Assessment (NCHA) Mental Health Item	The NCHA Mental Health Item contains two brief questions regarding adapting after changes/hardships occur. The scores range from 0-Not at all true to 4-True all the time. A higher score equates to greater ability to adapt after changes.	Change from baseline to post-intervention, around 8 weeks after baseline
Secondary	Columbia Suicide Severity Rating Scale	The Columbia Suicide Severity Rating Scale (CSSRS) is a scale containing 16 items which measures suicidality in 3 distinct sections: severity, intensity, and behavior. Answers are "yes" or "no", and scores are determined based on yes/no responses to each question and an added sum of intensity of ideation, ranging from 2-25 with higher scores meaning more intense suicide ideation.	Change from baseline to post-intervention, around 8 weeks after baseline
Secondary	World Health Organization (WHO) Performance Questionnaire Item A9		Change from baseline to post-intervention, around 8 weeks after baseline