Sleep Wellness Program - University REST

NCT04311372 | Withdrawn

• 1 other identifier: TBD3
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Poor Quality Sleep; Sleep Disturbance

Keywords

Mental Health; College Students; Sleep; Educational Intervention

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

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

Secondary Outcomes (3)

• National College Health Assessment (NCHA) Mental Health Item

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

• Columbia Suicide Severity Rating Scale

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

• World Health Organization (WHO) Performance Questionnaire Item A9

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

Study Arms (2)

Educational session+Material+Videos (Group 1)

EXPERIMENTAL

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

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)

Behavioral: Educational Sesssion+Material ONLY

Interventions

Educational Sesssion+Material+Videos BEHAVIORAL

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

Also known as: Group 1

Educational session+Material+Videos (Group 1)

Educational Sesssion+Material ONLY BEHAVIORAL

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

Also known as: Group 2

Educational session+Material ONLY (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Parasomnias; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: 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)

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: October 15, 2020
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: July 31, 2025

Record last verified: 2020-03