Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000254796
Ethics application status
Approved
Date submitted
3/02/2022
Date registered
11/02/2022
Date last updated
16/06/2024
Date data sharing statement initially provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Goodnight Poor Sleep: Evaluating a Brief Sleep Intervention for University Students
Scientific title
Goodnight Poor Sleep: Evaluating a Brief Sleep Intervention for University Students
Secondary ID [1] 306300 0
None
Universal Trial Number (UTN)
Trial acronym
GPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disturbance 325059 0
Condition category
Condition code
Mental Health 322496 322496 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] 322731 0
Treatment: Other
Intervention code [2] 322732 0
Behaviour
Comparator / control treatment
The GPS intervention will be compared to a waitlist (no treatment) control group. The waitlist control group will receive the intervention after they complete "post-treatment" measures (i.e., two weeks after the GPS group).
Control group
Active

Outcomes
Primary outcome [1] 330286 0
Self-reported sleep diary parameters (e.g., sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency)
Timepoint [1] 330286 0
Pre-treatment (1 week), Treatment Week 1, Treatment Week 2 (Primary Endpoint)
Secondary outcome [1] 405575 0
Adolescent Sleep Hygiene Scale Scores
Timepoint [1] 405575 0
Baseline, Pre-Treatment, 2 Weeks Post-Treatment
Secondary outcome [2] 405576 0
Insomnia Severity Index scores
Timepoint [2] 405576 0
Baseline, Pre-Treatment, 2 Weeks Post-Treatment
Secondary outcome [3] 405577 0
Epworth Sleepiness Scale score
Timepoint [3] 405577 0
Baseline, Pre-Treatment, 2 Weeks Post-Treatment
Secondary outcome [4] 405578 0
Fatigue Severity Scale score
Timepoint [4] 405578 0
Baseline, Pre-Treatment, 2 Weeks Post-Treatment
Secondary outcome [5] 405579 0
The Substances and Choices Scale score
Timepoint [5] 405579 0
Baseline, Pre-Treatment, 2 Weeks Post-Treatment
Secondary outcome [6] 405580 0
Depressive symptoms assessed by PHQ-9 scores
Timepoint [6] 405580 0
Baseline, Pre-Treatment, 2 Weeks Post-Treatment
Secondary outcome [7] 405581 0
Anxiety symptoms assessed by GAD-7 scores
Timepoint [7] 405581 0
Baseline, Pre-Treatment, 2 Weeks Post-Treatment
Secondary outcome [8] 406036 0
Actigraphy sleep parameters (e.g., sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency)
Timepoint [8] 406036 0
Pre-treatment (1 week), Treatment Week 1, Treatment Week 2

Eligibility
Key inclusion criteria
University students aged 17-25 years
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No explicit exclusion criteria.

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)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
86 participants are needed to detect medium differences between the two groups across 3 time-points with 80% power.

Linear Mixed Model Regressions will be used for statistical analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2022
Actual
5/04/2022
Date of last participant enrolment
Anticipated
14/03/2024
Actual
28/09/2023
Date of last data collection
Anticipated
5/04/2024
Actual
20/10/2023
Sample size
Target
86
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310646 0
University
Name [1] 310646 0
University of Western Australia
Country [1] 310646 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway, Crawley, WA. 6009
Country
Australia
Secondary sponsor category [1] 311856 0
None
Name [1] 311856 0
Address [1] 311856 0
Country [1] 311856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310243 0
University of Western Australia Human Ethics Committee
Ethics committee address [1] 310243 0
Ethics committee country [1] 310243 0
Australia
Date submitted for ethics approval [1] 310243 0
Approval date [1] 310243 0
10/03/2020
Ethics approval number [1] 310243 0

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

Contacts
Principal investigator
Name 116978 0
Dr Melissa Ree
Address 116978 0
University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009.
Country 116978 0
Australia
Phone 116978 0
+61864888693
Fax 116978 0
Email 116978 0
[email protected]
Contact person for public queries
Name 116979 0
Melissa Ree
Address 116979 0
University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009.
Country 116979 0
Australia
Phone 116979 0
+61864888693
Fax 116979 0
Email 116979 0
[email protected]
Contact person for scientific queries
Name 116980 0
Melissa Ree
Address 116980 0
University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009.
Country 116980 0
Australia
Phone 116980 0
+61864888693
Fax 116980 0
Email 116980 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.