NCT05933746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

June 27, 2023

Last Update Submit

July 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sleep disturbance short-form b

    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 Outcomes (2)

  • Perceived Stress Scale

    Change from baseline to 2-week follow-up

  • Sleep Hygiene Inventory

    Change from baseline to 2-week follow-up

Study Arms (2)

Sleep Hygiene Intervention

EXPERIMENTAL

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

Behavioral: Sleep Hygiene Intervention

Non-behavioral Sleep Education

PLACEBO COMPARATOR

active, matched placebo condition that controls for engagement and rationale

Behavioral: Non-behavioral Sleep Education

Interventions

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.

Sleep Hygiene Intervention

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.

Non-behavioral Sleep Education

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Graduate students / professional students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalParasomnias

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Condition assignment is done automatically, on-line, to two active experiences. Follow-up assessment is done automatically (on-line measure completion).
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

March 1, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations