- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05093465
A Comparison of Two Behavioral Sleep Interventions Among College Students (ProjectTECH)
October 25, 2021 updated by: Oakland University
A Comparison Trial of Two Behavioral Sleep Interventions to Improve Sleep-related Outcomes and Reduce Technology Usage Among College Students
The study was a randomized controlled trial designed to examine whether augmenting traditional sleep hygiene and stimulus control procedures with technology use reduction stimulus control procedures would produce better sleep and technology usage outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sixty college students were randomized to a 4-week sleep hygiene and stimulus control intervention (ACI) or an enhanced intervention including technology stimulus control instructions (TI).
Study Type
Interventional
Enrollment (Actual)
60
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
-
Rochester, Michigan, United States, 48309
- Oakland 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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must be at least 18 years old, enrolled at Oakland University, and reside in an on-campus dormitory to participate.
Exclusion Criteria:
- None
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Active Control
Participants were provided with sleep hygiene and stimulus control procedures.
|
Participants were provided with sleep hygiene and stimulus control procedures.
|
|
EXPERIMENTAL: Technology Intervention
Participants were given the same intervention materials as the active control condition plus procedures to change technology use.
|
Participants were provided with sleep hygiene and stimulus control procedure plus procedures to reduce technology usage in bed (i.e., technology usage stimulus control). In addition to the sleep hygiene and stimulus control procedures, participants were also given a set of procedures aimed at changing technology usage behavior at bedtime and throughout the day. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality
Time Frame: From baseline to posttest, approximately 5 weeks
|
Scores on the Pittsburgh Sleep Quality Index
|
From baseline to posttest, approximately 5 weeks
|
|
Technology Usage
Time Frame: From baseline to posttest, approximately 5 weeks
|
Self-reported usage of various forms of technology in minutes
|
From baseline to posttest, approximately 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Hygiene
Time Frame: From baseline to posttest, approximately 5 weeks
|
Scores on the Sleep Hygiene Practice Scale
|
From baseline to posttest, approximately 5 weeks
|
|
Sleep Control
Time Frame: From baseline to posttest, approximately 5 weeks
|
Scores on the Motivation Survey
|
From baseline to posttest, approximately 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea T Kozak, PhD, Oakland University
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)
September 25, 2018
Primary Completion (ACTUAL)
July 31, 2019
Study Completion (ACTUAL)
July 31, 2019
Study Registration Dates
First Submitted
October 14, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (ACTUAL)
October 26, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBID1306257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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