Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000105549
Ethics application status
Approved
Date submitted
21/12/2023
Date registered
7/02/2024
Date last updated
15/05/2024
Date data sharing statement initially provided
7/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Revising Evening Screen Time (REST-O): An online intervention.
Scientific title
Revising bedtime electronic device use: A randomised three-arm online pilot and feasibility trial in new career starters.
Secondary ID [1] 311351 0
None
Universal Trial Number (UTN)
Trial acronym
REST-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadequate sleep 332435 0
Condition category
Condition code
Public Health 329122 329122 0 0
Health promotion/education
Neurological 329313 329313 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aims of this project are to assess the effects and feasibility of an online intervention for bedtime device use in new career starters through a pilot trial. Participants will be randomised into three arms that will receive different Behaviour Change Techniques (BCTs), inclusive of one control group, over a three-week period. The intervention arms are described below.

Arm 2 - Substitute
Week 1:
- Participants will self-monitor the outcomes of their behaviour and emotional consequences using a sleep diary, to enable researchers to guide participants to form a personalised intervention plan.

End of Week 1:
- Participants will watch a 10-15 minute informational video about the behaviour change techniques.
Participants will then attend a personalised coaching session to set a goal for their desired behaviour in week 2.
- The coaching session will run for 15 minutes, and will be virtually delivered by the lead investigator, a PhD student. Questions will be prompted using PowerPoint slides.
- During the informational video, the Substitute condition will be prompted to think of a substitute behaviour for the bedtime period, defined as the 90 minutes prior to intended bedtime.
- During the informational video, participants will be given examples of evening substitute behaviours, such as reading a book, listening to a sleep story, or listening to a meditation.
- Following the video and during the coaching session, participants will problem solve by analysing the contributing factors towards their behaviour, and suggest a way they could change. Participants will devise a substitute behaviour where they are prompted to think of a wanted or neutral behaviour to replace bedtime device use.

Week 2:
- Participants will self-monitor their substitute behaviour for one week, filling out a daily sleep diary.

Week 3:
- Participants will continue to self-monitor their substitute behaviour for one week on their own (i.e., sleep diary is not mandatory).

Arm 3 - Prevent
Arm 3 only differs from Arm 2 in terms of the time the substitute behaviour will be performed. The ‘prevent’ arm will perform the substitute behaviour at a time prior to the bedtime period (earlier than 90 minutes before intended bedtime).

Week 1:
- Participants will self-monitor the outcomes of their behaviour and emotional consequences using a sleep diary, to enable researchers to guide participants to form a personalised intervention plan.

End of Week 1:
- Participants will watch a 10-15 minute informational video about the behaviour change techniques.
Participants will then attend a personalised coaching session to set a goal for their desired behaviour in week 2.
- The coaching session will run for 15 minutes, and will be virtually delivered by the lead investigator, a PhD student. Questions will be prompted using PowerPoint slides.
- In the informational video, the Prevent condition will be prompted to think of a substitute behaviour for a specific daytime context (e.g., in their lunch break, on their commute home from work, immediately after dinner), with the aim of preventing the behaviour in the evening.
- In the informational video, participants will be given examples of daytime substitute behaviours, such as watching a YouTube video during their lunch break, listening to a podcast on their commute home from work, or playing video games immediately after dinner.
- Following the video and during the coaching session, participants will problem solve by analysing the contributing factors towards their behaviour, and suggest a way they could change. Participants will devise a substitute behaviour where they are prompted to think of a wanted or neutral behaviour to replace bedtime device use.

Week 2:
- Participants will self-monitor their substitute behaviour for one week, filling out a daily sleep diary.

Week 3:
- Participants will continue to self-monitor their substitute behaviour for one week on their own (i.e., sleep diary is not mandatory).
Intervention code [1] 327686 0
Behaviour
Comparator / control treatment
Arm 1 - Control
Week 1:
- Participants will self-monitor the outcomes of their behaviour and emotional consequences using a sleep diary.

End of Week 1:
- Participants will watch a 10-15 minute informational video about the behaviour change techniques.
- Participants will then attend a personalised coaching session to set a goal for week 2.
- The coaching session will run for 15 minutes, and will be virtually delivered by the lead investigator, a PhD student. Questions will be prompted using PowerPoint slides.

Week 2:
- Participants will self-monitor their behaviour in relation to their goal for one week, filling out a daily sleep diary.

Week 3:
- Participants will continue to self-monitor their behaviour in relation to their goal for one week on their own (i.e., sleep diary is not mandatory).
Control group
Active

Outcomes
Primary outcome [1] 336959 0
Sleep duration
Timepoint [1] 336959 0
Assessment will be at 4 timepoints, Baseline, end of Week 1, end of Week 2, end of Week 3 post-randomisation.
Primary outcome [2] 336960 0
Sleep quality
Timepoint [2] 336960 0
Assessment will be at 4 timepoints, Baseline, end of Week 1, end of Week 2, end of Week 3 post-randomisation.
Primary outcome [3] 336961 0
Bedtime device use
Timepoint [3] 336961 0
A daily measure completed retrospectively (upon waking) for the previous night's screen time, completed daily during week 1 and week 2 post-randomisation.
Secondary outcome [1] 430252 0
Bedtime procrastination
Timepoint [1] 430252 0
Assessment will be at 4 timepoints, Baseline, end of Week 1, end of Week 2, end of Week 3 post-randomisation.
Secondary outcome [2] 430253 0
Device dependency
Timepoint [2] 430253 0
Assessment will be at 4 timepoints, Baseline, end of Week 1, end of Week 2, end of Week 3 post-randomisation.
Secondary outcome [3] 430822 0
Survey completion rate
Timepoint [3] 430822 0
Assessment will be at 3 timepoints, end of Week 1, end of Week 2, end of Week 3 post-randomisation.
Secondary outcome [4] 430823 0
Intervention attrition rate
Timepoint [4] 430823 0
Assessment will be at 3 timepoints, end of Week 1, end of Week 2, end of Week 3 post-randomisation.

Eligibility
Key inclusion criteria
Participants will be screened to ensure they have (1) finished full-time tertiary study and started full-time employment in the past 12 months, (2) are over 18 years of age, and (3) engage in bedtime procrastination (“Do you often procrastinate going to sleep?”).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who have been previously treated for a sleep disorder will be excluded, to minimise potential confounding factors.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used (Kang et al., 2008) to ensure even group sizes, with participants assigned to a group upon signup in a random sequence (e.g., CSP, PCS, SPC, PSC, SCP, CPS) until desired group size is reached. Participants will be blind to experimental group will not know the group to which they have been assigned.
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
Targeting a small effect size, we aim to recruit 60 participants (20 per arm) for 80% power.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
29/04/2024
Date of last participant enrolment
Anticipated
27/05/2024
Actual
Date of last data collection
Anticipated
17/06/2024
Actual
Sample size
Target
60
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315484 0
University
Name [1] 315484 0
Central Queensland University
Country [1] 315484 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
554/700 Yaamba Rd, Norman Gardens QLD 4701
Country
Australia
Secondary sponsor category [1] 317558 0
None
Name [1] 317558 0
Address [1] 317558 0
Country [1] 317558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314393 0
CQU Human Research Ethics Committee (CQUHREC)
Ethics committee address [1] 314393 0
554/700 Yaamba Rd, Norman Gardens QLD 4701
Ethics committee country [1] 314393 0
Australia
Date submitted for ethics approval [1] 314393 0
13/11/2023
Approval date [1] 314393 0
18/01/2024
Ethics approval number [1] 314393 0
24611

Summary
Brief summary
The aim of this study is to assess the effects and feasibility of the intervention for bedtime device use in new career starters. Using a three-arm randomised design, we will investigate the effects of intentions and habit-based approaches to reduce bedtime device use. The primary outcomes will be sleep duration, sleep quality, and bedtime device use. The secondary outcomes will be bedtime procrastination and excessive device use. We will further measure habit strength and motivation as mechanisms of change. Feasibility items to be assessed include daily survey completion rate, intervention attrition rate, as well as the effect of the intervention on outcome variables. The intervention will take place online, over a two-week period with a information video and coaching session on Zoom, as our needs assessment indicated this was the most commonly requested duration, format, and delivery method for an intervention program.

It is hypothesised that:
1. Substitute and Prevent conditions will have a decrease in bedtime device use in week 2 compared to Control.
2. Substitute and Prevent conditions will have improved sleep outcomes in week 2 compared to week 1.
3. Substitute and Prevent conditions will have decreased bedtime procrastination scores, excessive device use and improved sleep quality at follow-up compared with baseline.
Trial website
Trial related presentations / publications
Public notes
Our formative research revealed that hedonic motivation was a consistent predictor of bedtime device use (Hill et al., in preparation). The Theory of Hedonic Motivation posits that psychological hedonism can influence behaviour through the mechanism of hedonic motivation; the automatic, impulsive, and uncontrollable desire or urge to engage in a behaviour (Williams, 2019). Hedonic motivation is underpinned by psychological hedonism, the idea that humans are evolutionarily predisposed to seek out pleasure and avoid displeasure (Williams et al., 2018). In the context of dual-process theory (Evans & Stanovich, 2013), hedonic motivation is akin to automatic processing, driven by impulse. Results of our formative research suggest that interventions targeting automatic processes, or habit, and impulsiveness may be effective in reducing bedtime device use (Hill et al., in preparation).

Contacts
Principal investigator
Name 131422 0
Ms Vanessa Hill
Address 131422 0
Central Queensland University, 400 Kent St, Sydney NSW 2000
Country 131422 0
Australia
Phone 131422 0
+61883784518
Fax 131422 0
Email 131422 0
v.hill@cqu.edu.au
Contact person for public queries
Name 131423 0
Ms Vanessa Hill
Address 131423 0
Central Queensland University, 400 Kent St, Sydney NSW 2000
Country 131423 0
Australia
Phone 131423 0
+61883784518
Fax 131423 0
Email 131423 0
v.hill@cqu.edu.au
Contact person for scientific queries
Name 131424 0
Ms Vanessa Hill
Address 131424 0
Central Queensland University, 400 Kent St, Sydney NSW 2000
Country 131424 0
Australia
Phone 131424 0
+61883784518
Fax 131424 0
Email 131424 0
v.hill@cqu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.