Sleep Wellness Program - University REST

March 13, 2020 updated by: Michael A. Grandner, University of Arizona
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational session+Material+Videos (Group 1)
n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
Behavioral: Educational Sesssion+Material+Videos
n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
Other Names:
  • Group 1
Active Comparator: Educational session+Material ONLY (Group 2)
n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
Behavioral: Educational Sesssion+Material ONLY
n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
Other Names:
  • Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Insomnia Severity Index (ISI)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in the Fatigue Severity Scale (FSS)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in the Epworth Sleepiness Scale (ESS)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in the Assessment of Sleep Environment (ASE)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in the Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in Generalized Anxiety Disorder (GAD-7)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Changes in Perceived Stress Scale (PSS)
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
National College Health Assessment (NCHA) Mental Health Item
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
Columbia Suicide Severity Rating Scale
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
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
World Health Organization (WHO) Performance Questionnaire Item A9
Time Frame: Change from baseline to post-intervention, around 8 weeks after baseline
Change from baseline to post-intervention, around 8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2020

Primary Completion (Anticipated)

March 15, 2021

Study Completion (Anticipated)

March 15, 2021

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBD3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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