Sleep Wellness Program - University REST

NCT ID: NCT04311372

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-10-15

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.

Conditions

Poor Quality Sleep; Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Educational session+Material+Videos (Group 1)

n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)

Group Type: EXPERIMENTAL

Educational Sesssion+Material+Videos

Intervention Type: BEHAVIORAL

n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)

Educational session+Material ONLY (Group 2)

n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)

Group Type: ACTIVE_COMPARATOR

Educational Sesssion+Material ONLY

Intervention Type: BEHAVIORAL

n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)

Interventions

Educational Sesssion+Material+Videos

n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)

Intervention Type: BEHAVIORAL

Educational Sesssion+Material ONLY

n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)

Intervention Type: BEHAVIORAL

Other Intervention Names

Group 1; Group 2

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

MICHAEL A GRANDNER

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TBD3

Identifier Type: -

Identifier Source: org_study_id