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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
Scientific title
A smartphone and wearable tool to manage problem anger in adults who have experienced trauma (Shift): A micro-randomized trial
Secondary ID [1] 313298 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD) 335640 0
Stress 335641 0
Problem anger 335639 0
Condition category
Condition code
Mental Health 332196 332196 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329874 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 339781 0
Anger intensity
Timepoint [1] 339781 0
The next time point (approximately 3-15 hours) after filling out each EMA.
Secondary outcome [1] 441797 0
Feasibility of the intervention
Timepoint [1] 441797 0
Pre-study; and after 30 days of using the app
Secondary outcome [2] 441796 0
Emotional Self Awareness
Timepoint [2] 441796 0
Time 3, after 30 days of using the app
Secondary outcome [3] 441287 0
Anger symptoms
Timepoint [3] 441287 0
Time 3 (post-study; 30 days after using the app)
Secondary outcome [4] 441795 0
Posttraumatic stress disorder
Timepoint [4] 441795 0
Time 3, after 30 days of using the app
Secondary outcome [5] 441288 0
Acceptability of the intervention
Timepoint [5] 441288 0
Time 3 (post-study, 30 days after using the app)
Secondary outcome [6] 441794 0
Anger rumination
Timepoint [6] 441794 0
Time 3, after 30 days of using the app

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 concealment is not possible, as every single participant receives both the intervention and the control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple, computerised randomisation coded to occur within the app itself
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/11/2024
Date of last participant enrolment
Anticipated
8/03/2025
Actual
Date of last data collection
Anticipated
6/04/2025
Actual
Sample size
Target
65
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317749 0
Government body
Name [1] 317749 0
National Health and Medical Research Council
Country [1] 317749 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320066 0
None
Name [1] 320066 0
Address [1] 320066 0
Country [1] 320066 0
Other collaborator category [1] 283276 0
University
Name [1] 283276 0
University of California, Irvine
Address [1] 283276 0
Country [1] 283276 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316435 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 316435 0
Ethics committee country [1] 316435 0
Australia
Date submitted for ethics approval [1] 316435 0
05/03/2024
Approval date [1] 316435 0
30/08/2024
Ethics approval number [1] 316435 0

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

Contacts
Principal investigator
Name 137890 0
Dr Olivia Metcalf
Address 137890 0
700 Swanston St, University of Melbourne, Carlton, Victoria, 3053
Country 137890 0
Australia
Phone 137890 0
+613 9035 5599
Fax 137890 0
Email 137890 0
[email protected]
Contact person for public queries
Name 137891 0
Olivia Metcalf
Address 137891 0
700 Swanston St, University of Melbourne, Carlton, Victoria, 3053
Country 137891 0
Australia
Phone 137891 0
+613 9035 5599
Fax 137891 0
Email 137891 0
[email protected]
Contact person for scientific queries
Name 137892 0
Olivia Metcalf
Address 137892 0
700 Swanston St, University of Melbourne, Carlton, Victoria, 3053
Country 137892 0
Australia
Phone 137892 0
+613 9035 5599
Fax 137892 0
Email 137892 0
[email protected]

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.