Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress

July 6, 2023 updated by: Mark A. Lumley, Wayne State University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Graduate students / professional students

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Hygiene Intervention
1-hour, on-line set of three modules pertaining to various sleep hygiene behaviors
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep disturbance short-form b
Time Frame: 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)
Change from baseline to 2-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: 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)
Change from baseline to 2-week follow-up
Sleep Hygiene Inventory
Time Frame: 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)
Change from baseline to 2-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-21-10-4095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data set, upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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