Poor Quality SleepNCT04311372
Sleep Wellness Program - University REST
A study testing Educational Sesssion+Material+Videos and Educational Sesssion+Material ONLY in people with Poor Quality Sleep and Sleep Disturbance, run by University of Arizona.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep, Sleep Disturbance
- What is being tested?
- Educational Sesssion+Material+Videos and Educational Sesssion+Material ONLY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Poor Quality Sleep, Sleep Disturbance
- Being tested
- Educational Sesssion+Material+Videos, Educational Sesssion+Material ONLY
- Keywords
- Mental Health, College Students, Sleep, Educational Intervention
- Medical subject headings
- Parasomnias, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Sesssion+Material+VideosBehavioural
Also called Group 1
n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
Educational Sesssion+Material ONLYBehavioural
Also called Group 2
n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
| Study group | Role | What they receive |
|---|---|---|
| Educational session+Material+Videos (Group 1) | Experimental | n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library) Receives: Behavioral: Educational Sesssion+Material+Videos |
| Educational session+Material ONLY (Group 2) | Active comparator | n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY) Receives: Behavioral: Educational Sesssion+Material ONLY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
Changes in the Pittsburgh Sleep Quality Index (PSQI)
A subjective measure of sleep. Score ranges from 0-21. Higher scores indicate worse sleep quality.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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).
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
Secondary outcomes (3)
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
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.
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
World Health Organization (WHO) Performance Questionnaire Item A9
Measured: Change from baseline to post-intervention, around 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start15 Oct 2020 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Why it stopped: Due to COVID 2020 pandemic, was unable to get started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHAEL A GRANDNER, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311372
- Sponsor's protocol ID
- TBD3
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Wellness Program - University REST
- ClinicalTrials.gov ID
- NCT04311372
- Acronym / sponsor ID
- TBD3
- Conditions
- Poor Quality Sleep, Sleep Disturbance
- Keywords
- Mental Health, College Students, Sleep, Educational Intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID 2020 pandemic, was unable to get started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Educational session+Material+Videos (Group 1) | Experimental | Behavioral: Educational Sesssion+Material+Videosn =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library) |
| Educational session+Material ONLY (Group 2) | Active comparator | Behavioral: Educational Sesssion+Material ONLYn =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Sesssion+Material+VideosAlso: Group 1n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library) | Behavioural | Educational session+Material+Videos (Group 1) |
| Educational Sesssion+Material ONLYAlso: Group 2n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY) | Behavioural | Educational session+Material ONLY (Group 2) |
Primary outcome
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.
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.
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.
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.
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.
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.
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).
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.
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.
3 secondary outcomes
National College Health Assessment (NCHA) Mental Health Item
Time frame: 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
World Health Organization (WHO) Performance Questionnaire Item A9
Time frame: Change from baseline to post-intervention, around 8 weeks after baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Sesssion+Material+Videos and Educational Sesssion+Material ONLY in people with Poor Quality Sleep and Sleep Disturbance, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Insomnia Severity Index (ISI) (time frame: Change from baseline to post-intervention, around 8 weeks after baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.