Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000055404
Ethics application status
Approved
Date submitted
26/11/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of an Online Sleep Health Education Intervention on Sleep and Mental Health of Young Adults
Scientific title
An Online Education Intervention on Sleep Health and its Impact on Sleep and Negative Emotional States in Young Adults: A Randomised Controlled Trial
Secondary ID [1] 313245 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Negative emotional states 335563 0
Poor sleep health 335562 0
Condition category
Condition code
Public Health 332135 332135 0 0
Health promotion/education
Mental Health 332452 332452 0 0
Anxiety
Mental Health 332200 332200 0 0
Depression
Mental Health 332199 332199 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will access the intervention through the online survey platform (likely Qualtrics). The video will become accessible to intervention group participants immediately following completion of the baseline data collection (survey). The intervention video will be embedded into the platform. Participants will be randomly allocated to the intervention or control group using the platforms random allocation function.

The intervention will include an engaging multi-media explainer video designed for young adults. It will use a narrative approach, featuring a main character who represents our target population. Guided by a narrator (spoken by either one of the investigators or a computer-generated voiceover), the viewers are guided on an animated journey exploring some of the key dimensions of sleep health (e.g., regularity, alertness, timing, efficiency, duration), including norms and common challenges experiences by young adults. This content will be developed based on the National Sleep Foundations Sleep Duration and Quality Guidelines and recent relevant empirical research. There will also be information on basic sleep physiology. The intervention video will be approximately 10 minutes in duration.

Adherence of the intervention will be monitored through analytics from the online survey platform that displays how long participants stayed on the intervention video/page.
Intervention code [1] 329825 0
Prevention
Comparator / control treatment
Waitlist Control Group.

Participants in the control condition will be given the opportunity to watch the online education intervention video after completion of the 1-week follow up survey. It will become available to view in the online survey platform.
Control group
Active

Outcomes
Primary outcome [1] 340147 0
Sleep satisfaction
Timepoint [1] 340147 0
1 week post intervention completion
Primary outcome [2] 339710 0
Sleep health (composite measure using validated scale that considers specific sleep dimensions including regularity, satisfaction, alertness, timing, efficiency and duration).
Timepoint [2] 339710 0
1-week post intervention completion.
Secondary outcome [1] 440983 0
Negative Emotional States
Timepoint [1] 440983 0
1 week post intervention completion

Eligibility
Key inclusion criteria
Aged 18 to 25 years old
Australian Resident
English Proficiency
Sleep Dissatisfied (i.e. include only those who report not being completely satisfied with their sleep)
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who have been diagnosed with or received treatment for a sleep disorder (e.g., insomnia, obstructive sleep apnea, restless leg syndrome) in the past 12 months

Individuals diagnosed or treated for a mental health condition in the past 12 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed as done centrally by computer (specifically the online survey platform).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software (i.e. computerised sequence
generation) - Randomisation performed by survey platform (e.g. Qualtrics XM 'randomizer').
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori calculation, with d = .30, a = .05, and power = .80 indicated minimum number of participants as n = 24 in each group. Accounting for ~20% attrition for follow-up, n = 29. Thus, ~29 participants per group, and 58 participants in total.

Descriptive statistics will be used to summarise demographic information and baseline characteristics of the participants. To evaluate the efficacy of the intervention, a generalized linear mixed model will be employed for categorical outcomes, while a repeated measures ANOVA will be used for continuous outcomes. The group x time interaction will be used to determine intervention efficacy. Significance level of all statistical analysis will be set at p < .05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
10/08/2025
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317688 0
University
Name [1] 317688 0
University of the Sunshine Coast
Country [1] 317688 0
Australia
Primary sponsor type
Individual
Name
Dr Alexandra Metse - University of the Sunshine Coast
Address
Country
Australia
Secondary sponsor category [1] 320009 0
Individual
Name [1] 320009 0
Ethan Burgess - University of the Sunshine Coast
Address [1] 320009 0
Country [1] 320009 0
Australia
Secondary sponsor category [2] 320011 0
Individual
Name [2] 320011 0
Ashlee Flint - University of the Sunshine Coast
Address [2] 320011 0
Country [2] 320011 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316386 0
Human Research Ethics Committee of the University of the Sunshine Coast
Ethics committee address [1] 316386 0
Ethics committee country [1] 316386 0
Australia
Date submitted for ethics approval [1] 316386 0
14/10/2024
Approval date [1] 316386 0
05/11/2024
Ethics approval number [1] 316386 0
S242027

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137734 0
Dr Alexandra Metse
Address 137734 0
School of Health, University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs QLD 4556
Country 137734 0
Australia
Phone 137734 0
+61754563476
Fax 137734 0
Email 137734 0
[email protected]
Contact person for public queries
Name 137735 0
Alexandra Metse
Address 137735 0
School of Health, University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs QLD 455690 Sippy Downs Dr, Sippy Downs QLD 4556
Country 137735 0
Australia
Phone 137735 0
+61754563476
Fax 137735 0
Email 137735 0
[email protected]
Contact person for scientific queries
Name 137736 0
Alexandra Metse
Address 137736 0
School of Health, University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs QLD 455690 Sippy Downs Dr, Sippy Downs QLD 4556
Country 137736 0
Australia
Phone 137736 0
+61754563476
Fax 137736 0
Email 137736 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.