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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
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 13, 2020
    Last Updated
    March 13, 2020
    Sponsor
    University of Arizona
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    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

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