WithdrawnNot Applicable

Sleep Wellness Program - University REST

Stopped: Due to COVID 2020 pandemic, was unable to get started

0Started 2020-10-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Insomnia Severity Index (ISI)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Fatigue Severity Scale (FSS)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Epworth Sleepiness Scale (ESS)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Assessment of Sleep Environment (ASE)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Center for Epidemiologic Studies Depression Scale (CES-D)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Trial details

NCT IDNCT04311372

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-15

View on ClinicalTrials.gov More Poor Quality Sleep trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in Insomnia Severity Index (ISI)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Fatigue Severity Scale (FSS)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Epworth Sleepiness Scale (ESS)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Assessment of Sleep Environment (ASE)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline

Changes in the Center for Epidemiologic Studies Depression Scale (CES-D)

Timeframe: Change from baseline to post-intervention, around 8 weeks after baseline