Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress

Sponsor

Wayne State University (Other)

Overall Status

Completed

CT.gov ID

NCT05933746

Collaborator

(none)

108

Enrollment

Location

Arms

4.5

Actual Duration (Months)

24.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Poor sleep is common among college students and likely contributes to stress. The investigators developed a brief, remotely-delivered intervention and tested whether it improves sleep hygiene and reduced sleep disturbance and stress among undergraduates.

Condition or Disease	Intervention/Treatment	Phase
Stress, Emotional Sleep Disturbance	Behavioral: Sleep Hygiene Intervention Behavioral: Non-behavioral Sleep Education	N/A

Detailed Description

Poor sleep is common among college students and likely contributes to stress. The investigators developed a brief, remotely-delivered sleep hygiene intervention, which is delivered via the internet, and tested in a randomized controlled trial, whether it improves sleep hygiene and reduced sleep disturbance and stress in a sample of undergraduates who report wanting to improve their sleep. This study compares the novel sleep hygiene intervention to an active, matched control condition--sleep education. Baseline and 2-week follow-up questionnaires assess sleep hygiene, sleep disturbance, and stress. ANCOVAs will compare conditions at follow-up, and mediation tests will explore whether the intervention reduced stress through improved sleep.

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Condition assignment is done automatically, on-line, to two active experiences. Follow-up assessment is done automatically (on-line measure completion).

Primary Purpose:

Treatment

Official Title:

The Impact of a Remote, Brief, Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress: A Randomized, Controlled Trial

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Jul 15, 2022

Actual Study Completion Date :

Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sleep Hygiene Intervention 1-hour, on-line set of three modules pertaining to various sleep hygiene behaviors	Behavioral: Sleep Hygiene Intervention This 1-hour on-line intervention presents three sleep hygiene modules, selected randomly from among these six: establishing a bedtime routine, optimizing sleep environment, implementing a sleep schedule, bedtime relaxation, nutrition choices, and exercise habits.
Placebo Comparator: Non-behavioral Sleep Education active, matched placebo condition that controls for engagement and rationale	Behavioral: Non-behavioral Sleep Education 1-hour on-line set of three modules that cover non-skill (non-hygiene) educational topics (sleep research, sleep stages, dreams). This control condition equates for engagement rationale.

Arm

Intervention/Treatment

Experimental: Sleep Hygiene Intervention

1-hour, on-line set of three modules pertaining to various sleep hygiene behaviors

Behavioral: Sleep Hygiene Intervention

This 1-hour on-line intervention presents three sleep hygiene modules, selected randomly from among these six: establishing a bedtime routine, optimizing sleep environment, implementing a sleep schedule, bedtime relaxation, nutrition choices, and exercise habits.

Placebo Comparator: Non-behavioral Sleep Education

active, matched placebo condition that controls for engagement and rationale

Behavioral: Non-behavioral Sleep Education

1-hour on-line set of three modules that cover non-skill (non-hygiene) educational topics (sleep research, sleep stages, dreams). This control condition equates for engagement rationale.

Outcome Measures

Primary Outcome Measures

Sleep disturbance short-form b [Change from baseline to 2-week follow-up]
8-item measure assesses sleep disturbances over last 7 days (range: 8 to 40; higher scores = more sleep disturbance)

Secondary Outcome Measures

Perceived Stress Scale [Change from baseline to 2-week follow-up]
10-item measure of perceived stress over past 7 days (range 0 to 40; higher scores = more perceived stress)
Sleep Hygiene Inventory [Change from baseline to 2-week follow-up]
13-item measure of maladaptive sleep hygiene behaviors over last 7 days (range: 13-65; higher scores = worse hygiene)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undergraduate students at Wayne State University
Self-reported desire to improve their sleep

Exclusion Criteria:

Graduate students / professional students

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wayne State University	Detroit	Michigan	United States	48202

Sponsors and Collaborators

Wayne State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mark A. Lumley, Distinguished Professor, Wayne State University

ClinicalTrials.gov Identifier:

NCT05933746

Other Study ID Numbers:

IRB-21-10-4095

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Study Results

No Results Posted as of Jul 10, 2023