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Trial registered on ANZCTR
Registration number
ACTRN12624001400550
Ethics application status
Approved
Date submitted
3/11/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
A smartphone and wearable tool to manage anger after trauma (Shift): A micro-randomized trial
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Scientific title
A smartphone and wearable tool to manage problem anger in adults who have experienced trauma (Shift): A micro-randomized trial
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Secondary ID [1]
313298
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD)
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Stress
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Problem anger
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Condition category
Condition code
Mental Health
332196
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Shift is a just-in-time-adaptive intervention that has been co-designed with people who have experienced trauma and problem anger, as well as digital health experts and mental health professionals. Shift leverages ecological momentary assessments (EMAs) to determine an individual’s current anger state, and then delivers personalised cognitive behavioral components that focus on managing anger from a physiological, cognitive, or behavioral perspective. The intervention components of Shift leverage: 1) best practice approaches to manage anger rumination, improve unhealthy communication, and increase cognitive reframing; 2) an evidence-based method to decrease physiological arousal (i.e., cyclic sighing and isometric exercises) 3) circuit breakers for when anger is out of control; and 4) support for managing negative mood states after an anger outburst.
EMAs are sent four times per day, within a personalised schedule, and three reminders to complete each EMA are sent within the hour. Each EMA takes less than 30 seconds to complete. Adherence is recorded via the number of EMAs completed throughout the 30 days.
Shift tracks mood and anger triggers via self-report, provides external crisis support in the form of crisis helplines, and includes a virtual supportive Coach embedded in the app. The virtual Coach provides the welcome and rationale for the app, the voice overs for explaining skills, and supportive advice after an individual experiences an anger outburst.
Accompanying the Shift app, users have the option of also using a wearable, that tracks sleep, activity, and stress levels, and alerts the user when stress levels are high. Users can then choose to open Shift and access the intervention components, if they want to.
Participants will use their personal Android or iOS device to operate Shift. Wearable devices (Garmin activity trackers) will be provided to participants to monitor physiological stress and sleep. Those who do not choose to use the wearable will not track their sleep or stress through other methods.
This study will conduct a micro-randomized trial to test Shift's effect on anger intensity at the next decision point. Every participant at each decision point (i.e., 4 EMAs per day) will be randomised with 0.5 probability to be shown a additional app content tailored to the anger state, and with 0.5 probability to be shown nothing.
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Intervention code [1]
329874
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Treatment: Other
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Comparator / control treatment
The comparator is the instances (50:50) when the participants are shown nothing after completing an EMA. They receive a screen to say "Thank you, your check in has been recorded", and then the app returns to the home screen.
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Control group
Active
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Outcomes
Primary outcome [1]
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Anger intensity
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Assessment method [1]
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Self-reported on a 0-10 scale at the next decision point.
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Timepoint [1]
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The next time point (approximately 3-15 hours) after filling out each EMA.
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Secondary outcome [1]
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Feasibility of the intervention
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Assessment method [1]
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A composite of rates of recruitment, uptake, and retention, by auditing study enrolment and completion rates.
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Timepoint [1]
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Pre-study; and after 30 days of using the app
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Secondary outcome [2]
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Emotional Self Awareness
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Assessment method [2]
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Emotional Self Awareness Scale (ESAS)
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Timepoint [2]
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Time 3, after 30 days of using the app
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Secondary outcome [3]
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Anger symptoms
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Assessment method [3]
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Dimensions of Anger Reactions- 5 (DAR-5) State-Trait Anger Expression Inventory 2 (STAXI-2)
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Timepoint [3]
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Time 3 (post-study; 30 days after using the app)
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Secondary outcome [4]
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Posttraumatic stress disorder
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Assessment method [4]
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Posttraumatic Stress Disorder Checklist (PCL-5)
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Timepoint [4]
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Time 3, after 30 days of using the app
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Secondary outcome [5]
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Acceptability of the intervention
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Assessment method [5]
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System Usability Scale (SUS) Perceived Impact Scale of the User Mobile App Rating Scale (uMARS)
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Timepoint [5]
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Time 3 (post-study, 30 days after using the app)
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Secondary outcome [6]
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Anger rumination
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Assessment method [6]
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Anger Rumination Scale (ARS)
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Timepoint [6]
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Time 3, after 30 days of using the app
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Eligibility
Key inclusion criteria
1. be 18+ years;
2. have problem anger ( equal to or greater than 12 points on the Dimensions of Anger Reactions Scale);
3. report having experienced a previous traumatic event;
4. be physically located in Australia;
5. own an internet connected Android or iOS and have unhindered access during the study period
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. a recent history of significant violence (i.e., such as assault with a weapon, choking/strangulation, and/or inflicting an injury that requires medical assistance in the past six months)
2. currently undergoing psychological treatment for anger.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is not possible, as every single participant receives both the intervention and the control.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple, computerised randomisation coded to occur within the app itself
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
At each decision point, if a participant fills the ecological momentary assessment, they will be randomised with 0.5 probability to be shown the intervention components of Shift matched to their anger intensity, and with 0.5 probability to not be shown the intervention components. If the participant does not self-report their anger state (in which case the participant is considered unavailable for micro-randomisation), no micro-randomisation will occur, and no intervention components will be shown at that decision point.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary hypothesis is that receiving the app content with the intervention components after completing an EMA, as compared to nothing, will reduce proximal anger intensity, which is self-reported on a 0-10 scale at the next decision point. To assess the effect of receiving the app content with the intervention components on proximal anger intensity, we will use an extension of the weighted and centered least squares (WCLS) method by Boruvka et al. (2018) that handles missing outcomes. The input variables for the method include the outcome variable – self-reported anger intensity at the next decision point – and the following control covariates which will be included to reduce noise and increase the power to detect a significant treatment effect: sex, Dimensions of Anger Reactions Scale score at pre-study, Posttraumatic Stress Disorder symptoms, days in the study, self-report completion at the previous decision point, and anger intensity and anger state at the previous decision point . The availability indicator is whether the participant fills the EMA at the decision point. The treatment indicator is whether an intervention screen is shown at the decision point. No moderators are included because of the marginal nature of the hypothesis. Support for the hypothesis will be provided by finding a significant negative coefficient for the treatment indicator. This analytic approach uses robust standard errors to account for the dependence in outcomes across decision points within each participant and avoids causal bias.
If a participant does not fill an EMA at a decision point, the proximal outcome for the previous decision point will be missing. To account for missing data in the outcomes, we will investigate which observed variables can be used to explain the missing data, which may include baseline and time-varying covariates and the decision point index. These variables will be identified using a logistic additive model on the probability of an outcome being missing. Shrinkage- and likelihood-based variable selection methods will be used to select the final model for the missingness probability. The inverse of one minus the predicted missingness probability will be used as weights in the extension of Boruvka et al. (2018) to facilitate valid causal effect estimation with missing outcomes. Additionally, to increase confidence in the accuracy of our results, we plan to conduct sensitivity analyses. We will apply the original WCLS method to two extreme imputed data sets, where missing outcomes are imputed as all 0’s or all 10’s, and another imputed data set, where missing outcomes are imputed by person-specific means, to assess the sensitivity of the results to the missingness.
To test each of the secondary hypotheses, we will use the same analytic approach as the primary aim with the following changes. For (1), we will include the indicator of whether the participant reports “escalating” in the current EMA as both the moderator and an additional control variable. For (2), we will include the day in the study as both the moderator and an additional control variable. For (3), we will include an indicator of whether the current decision point is among the first three decision points of the day as both the moderator and an additional control variable. For each of the secondary hypotheses, support for the hypothesis will be provided by finding a significant effect moderation by the corresponding moderator. The same approach to handle missing data as in the primary aim will be used.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
8/11/2024
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Date of last participant enrolment
Anticipated
8/03/2025
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Actual
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Date of last data collection
Anticipated
6/04/2025
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Actual
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Sample size
Target
65
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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University of California, Irvine
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Address [1]
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Country [1]
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United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Melbourne Central Human Research Ethics Committee
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Ethics committee address [1]
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https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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05/03/2024
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Approval date [1]
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30/08/2024
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Ethics approval number [1]
316435
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Summary
Brief summary
Problem anger after experiencing trauma is a common mental health issue. Shift is a new cognitive-behavioral based just-in-time-adaptive intervention (JITAI), co-designed with users and experts, that works by prompting users to report their current anger state, and delivering personalised support to manage anger accordingly. A micro-randomised trial will be implemented with 65 adults with problem anger and a history of trauma exposure. For 30 days, four times a day, each participant will be prompted to self-report their current anger state, and will be randomised to be shown intervention components tailored to their anger state, or not. Post intervention surveys, and app use and engagement indices will be analysed to evaluate the acceptability of the intervention. The aim of the study is to test whether the intervention components designed within Shift actually reduce anger intensity. To test this, we are using a novel type of method, called a micro-randomised trial, where every participant will recieve both the intervention and the control at different times. This will be the first digital trial using micro-randomisation to optimise a JITAI for problem anger in a population who have experienced trauma, and one of the few micro-randomised trials to optimise digital mental health tools to manage dysregulated mood.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Olivia Metcalf
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Address
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700 Swanston St, University of Melbourne, Carlton, Victoria, 3053
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Country
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Australia
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Phone
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+613 9035 5599
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Olivia Metcalf
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Address
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700 Swanston St, University of Melbourne, Carlton, Victoria, 3053
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Country
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Australia
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Phone
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+613 9035 5599
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Olivia Metcalf
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Address
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700 Swanston St, University of Melbourne, Carlton, Victoria, 3053
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Country
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Australia
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Phone
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+613 9035 5599
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
This is sensitive data from vulnerable individuals.
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.
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