Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000829516
Ethics application status
Approved
Date submitted
12/06/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Goodnight, Poor Sleep: Evaluation of a brief peer-led sleep intervention for university students
Scientific title
Goodnight, Poor Sleep: Evaluating the effect of a brief peer-led sleep intervention on sleep and mental health in university students
Secondary ID [1] 312325 0
None
Universal Trial Number (UTN)
Trial acronym
GPS
Linked study record
ACTRN12622000254796 was an initial trial of efficacy of the "Goodnight, Poor Sleep" intervention. The current study is a follow-up secondary trial.

Health condition
Health condition(s) or problem(s) studied:
Sleep Disturbance 334082 0
Condition category
Condition code
Mental Health 330760 330760 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Goodnight Poor Sleep is a one off, brief (10-20-minute), sleep intervention based on principles of cognitive behavioural therapy for insomnia and motivational interviewing. First, participants complete an adapted version of the Adolescent Sleep Hygiene Scale (up to 15 minutes). Participants are then given general sleep health information and general sleep hygiene information (developed specifically for this study; delivered via flipchart). Following this, participants receive one of three treatment arms: 1) Still your mind, which aims to reduce high emotional and cognitive arousal before sleep; 2) Get sleepy, which provides information about physiological sleep drive and regularising sleep and wake times, and; 3) Bust fatigue, which helps students organise daytime habits to reduce fatigue. Participants are allocated to one of the three treatment arms, based on their responses to the adapted Adolescent Sleep Hygiene Scale (ASHS). If participants have an average ASHS subscale score of 3 or more, then the corresponding treatment arm is delivered. If multiple treatment arms are recommended (scoring above threshold on more than one ASHS subscale), then the participant chooses which concern they would like to prioritise, and the corresponding treatment arm is delivered.
Goodnight Poor Sleep is delivered by peer educators (undergraduate university students) with little or no prior sleep knowledge. Peer educators are first trained by a member of the research team (e.g., Co-ordinator of Health Promotion Unit). Peer educators guide participants through the GPS intervention using a manualised flip chart. Participants are given a double sided A4 pamphlet to take home, which summarises key therapeutic messages. The intervention will be delivered face-to-face on the university campus, where possible (e.g., if unaffected by pandemic restrictions). If face-to-face administration is not possible, the intervention will be delivered online via telehealth. To monitor adherence to the manualised treatment, a second peer educator will complete an observers checklist on a subset of interventions.
Intervention code [1] 328803 0
Treatment: Other
Intervention code [2] 328804 0
Behaviour
Comparator / control treatment
The GPS intervention will be compared to an active, educational control intervention (i.e., a 10-20-minute sleep education session). The active control group will receive general sleep-related information, delivered by a trained peer educator, facilitated by both a manualised flipchart and pamphlet. Participants in the control group can opt to receive the GPS intervention after they complete “post-treatment” measures (i.e., at the 6-month follow-up session).
Control group
Active

Outcomes
Primary outcome [1] 338517 0
Insomnia Symptoms
Timepoint [1] 338517 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline; primary timepoint), 1- and 6-month follow-up
Primary outcome [2] 338519 0
Sleep Hygiene
Timepoint [2] 338519 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline; primary timepoint), 1- and 6-month follow-up
Secondary outcome [1] 436249 0
Daytime Sleepiness
Timepoint [1] 436249 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [2] 436250 0
Fatigue
Timepoint [2] 436250 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [3] 436251 0
Depressive symptoms
Timepoint [3] 436251 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [4] 436252 0
Anxiety symptoms
Timepoint [4] 436252 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [5] 436253 0
Substance Use
Timepoint [5] 436253 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [6] 436254 0
Emotion regulation competence
Timepoint [6] 436254 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [7] 436255 0
Repetitive Negative Thinking
Timepoint [7] 436255 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [8] 436256 0
Loneliness
Timepoint [8] 436256 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [9] 436258 0
Academic Stress
Timepoint [9] 436258 0
baseline, pre-treatment (1 week after baseline), post-treatment (3 weeks after baseline), 1- and 6-month follow-up
Secondary outcome [10] 436901 0
Self-reported sleep onset latency
Timepoint [10] 436901 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)
Secondary outcome [11] 436903 0
Self-reported wake after sleep onset
Timepoint [11] 436903 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)
Secondary outcome [12] 436904 0
Self-reported total sleep time
Timepoint [12] 436904 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)
Secondary outcome [13] 436905 0
Self-reported sleep efficiency
Timepoint [13] 436905 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)
Secondary outcome [14] 436906 0
Objective sleep onset latency
Timepoint [14] 436906 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)
Secondary outcome [15] 436907 0
Objective wake after sleep onset
Timepoint [15] 436907 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)
Secondary outcome [16] 436908 0
Objective total sleep time
Timepoint [16] 436908 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)
Secondary outcome [17] 436909 0
Objective sleep efficiency
Timepoint [17] 436909 0
pre-treatment (1 week), post-treatment (2 weeks), 1- and 6-month follow-up (1 week each)

Eligibility
Key inclusion criteria
University students aged 17-25, who have interest in improving their sleep
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation schedule will be held by central administrator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation sequence with blocks of 2 and 4
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To achieve 80% power, 156 participants are needed to detect small-to-moderate between-group effects across two groups (GPS vs. control) over five timepoints (baseline, pre-treatment, post-treatment, 1-month follow-up, 6-months follow-up).

Linear Mixed Model Regressions will be used for statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/07/2028
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316722 0
Charities/Societies/Foundations
Name [1] 316722 0
Raine Medical Research Foundation
Country [1] 316722 0
Australia
Funding source category [2] 316726 0
Government body
Name [2] 316726 0
National Health and Medical Research Council
Country [2] 316726 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 318932 0
None
Name [1] 318932 0
Address [1] 318932 0
Country [1] 318932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315497 0
University of Western Australia Human Ethics Committee
Ethics committee address [1] 315497 0
Ethics committee country [1] 315497 0
Australia
Date submitted for ethics approval [1] 315497 0
28/11/2023
Approval date [1] 315497 0
01/03/2024
Ethics approval number [1] 315497 0

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

Contacts
Principal investigator
Name 134882 0
Dr Cele Richardson
Address 134882 0
University of Western Australia, 35 Stirling Highway Crawley WA 6009
Country 134882 0
Australia
Phone 134882 0
+61 8 6488 3141
Fax 134882 0
Email 134882 0
[email protected]
Contact person for public queries
Name 134883 0
Dr Cele Richardson
Address 134883 0
University of Western Australia, 35 Stirling Highway Crawley WA 6009
Country 134883 0
Australia
Phone 134883 0
+61 8 6488 3141
Fax 134883 0
Email 134883 0
[email protected]
Contact person for scientific queries
Name 134884 0
Dr Cele Richardson
Address 134884 0
University of Western Australia, 35 Stirling Highway Crawley WA 6009
Country 134884 0
Australia
Phone 134884 0
+61 8 6488 3141
Fax 134884 0
Email 134884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data will be shared after de-identification only. Participant data of published results and other available data will be shared upon reasonable request.
When will data be available (start and end dates)?
Data will be made available following publication of outcomes, and will remain available as long as data is stored (in compliance with retention policies).
Available to whom?
Only researchers who provide a methodologically sound proposal will have access to the data.
Available for what types of analyses?
Methodologically sound projects and meta-analyses.
How or where can data be obtained?
By contacting principal investigator at [email protected].


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.