Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress
Primary Purpose
Stress, Emotional, Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Hygiene Intervention
Non-behavioral Sleep Education
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Emotional
Eligibility Criteria
Inclusion Criteria: Undergraduate students at Wayne State University Self-reported desire to improve their sleep Exclusion Criteria: Graduate students / professional students
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sleep Hygiene Intervention
Non-behavioral Sleep Education
Arm Description
1-hour, on-line set of three modules pertaining to various sleep hygiene behaviors
active, matched placebo condition that controls for engagement and rationale
Outcomes
Primary Outcome Measures
Sleep disturbance short-form b
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
10-item measure of perceived stress over past 7 days (range 0 to 40; higher scores = more perceived stress)
Sleep Hygiene Inventory
13-item measure of maladaptive sleep hygiene behaviors over last 7 days (range: 13-65; higher scores = worse hygiene)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05933746
Brief Title
Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress
Official Title
The Impact of a Remote, Brief, Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Emotional, Sleep Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Condition assignment is done automatically, on-line, to two active experiences. Follow-up assessment is done automatically (on-line measure completion).
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Hygiene Intervention
Arm Type
Experimental
Arm Description
1-hour, on-line set of three modules pertaining to various sleep hygiene behaviors
Arm Title
Non-behavioral Sleep Education
Arm Type
Placebo Comparator
Arm Description
active, matched placebo condition that controls for engagement and rationale
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-behavioral Sleep Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep disturbance short-form b
Description
8-item measure assesses sleep disturbances over last 7 days (range: 8 to 40; higher scores = more sleep disturbance)
Time Frame
Change from baseline to 2-week follow-up
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
10-item measure of perceived stress over past 7 days (range 0 to 40; higher scores = more perceived stress)
Time Frame
Change from baseline to 2-week follow-up
Title
Sleep Hygiene Inventory
Description
13-item measure of maladaptive sleep hygiene behaviors over last 7 days (range: 13-65; higher scores = worse hygiene)
Time Frame
Change from baseline to 2-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergraduate students at Wayne State University
Self-reported desire to improve their sleep
Exclusion Criteria:
Graduate students / professional students
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data set, upon reasonable request
Learn more about this trial
Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress
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