Sleep Wellness Program - University REST
Primary Purpose
Poor Quality Sleep, Sleep Disturbance
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational Sesssion+Material+Videos
Educational Sesssion+Material ONLY
Sponsored by
About this trial
This is an interventional basic science trial for Poor Quality Sleep focused on measuring Mental Health, College Students, Sleep, Educational Intervention
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Educational session+Material+Videos (Group 1)
Educational session+Material ONLY (Group 2)
Arm Description
n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
Outcomes
Primary Outcome Measures
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.
Changes in the Pittsburgh Sleep Quality Index (PSQI)
A subjective measure of sleep. Score ranges from 0-21. Higher scores indicate worse sleep quality.
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.
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.
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.
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.
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).
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.
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.
Secondary Outcome Measures
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.
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.
World Health Organization (WHO) Performance Questionnaire Item A9
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04311372
Brief Title
Sleep Wellness Program - University REST
Official Title
Sleep Wellness Program - University REST
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2020 (Anticipated)
Primary Completion Date
March 15, 2021 (Anticipated)
Study Completion Date
March 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Quality Sleep, Sleep Disturbance
Keywords
Mental Health, College Students, Sleep, Educational Intervention
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational session+Material+Videos (Group 1)
Arm Type
Experimental
Arm Description
n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
Arm Title
Educational session+Material ONLY (Group 2)
Arm Type
Active Comparator
Arm Description
n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
Intervention Type
Behavioral
Intervention Name(s)
Educational Sesssion+Material+Videos
Other Intervention Name(s)
Group 1
Intervention Description
n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
Intervention Type
Behavioral
Intervention Name(s)
Educational Sesssion+Material ONLY
Other Intervention Name(s)
Group 2
Intervention Description
n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
Primary Outcome Measure Information:
Title
Changes in Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in the Pittsburgh Sleep Quality Index (PSQI)
Description
A subjective measure of sleep. Score ranges from 0-21. Higher scores indicate worse sleep quality.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in the Fatigue Severity Scale (FSS)
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in the Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in the Assessment of Sleep Environment (ASE)
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in the Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Changes in Perceived Stress Scale (PSS)
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Secondary Outcome Measure Information:
Title
National College Health Assessment (NCHA) Mental Health Item
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
Columbia Suicide Severity Rating Scale
Description
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.
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
Title
World Health Organization (WHO) Performance Questionnaire Item A9
Time Frame
Change from baseline to post-intervention, around 8 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Grandner, PhD, MTR
Phone
5206266346
Email
grandner@email.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Grandner, PhD, MTR
Phone
5206266346
Email
grandner@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Sleep Wellness Program - University REST
We'll reach out to this number within 24 hrs