RecruitingACTRN12624001400550

A smartphone and wearable tool to manage anger after trauma (Shift): A micro-randomized trial

A smartphone and wearable tool to manage problem anger in adults who have experienced trauma (Shift): A micro-randomized trial


Sponsor

University of Melbourne

Enrollment

65 participants

Start Date

Nov 8, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Experiencing a traumatic event can sometimes lead to intense and difficult-to-control anger. This type of 'problem anger' is common after trauma and can interfere with relationships, work, and daily life. While effective therapies exist, many people can't easily access them. Shift is a new smartphone-based anger management tool developed with input from both users and clinicians, delivering personalised support based on a person's current anger level. This study uses a micro-randomised trial design — a novel clinical trial method where each participant is randomly assigned multiple times over 30 days, receiving either the active Shift intervention or no intervention at different moments during the day. This allows researchers to test which specific components of the app actually reduce anger intensity in real time. The study also assesses acceptability and engagement with the app. You may be eligible if you are aged 18 to 50, have experienced a traumatic event, score above the threshold for problem anger on a validated scale, live in Australia, and own a smartphone. People who are currently receiving psychological treatment specifically for anger, or who have engaged in serious physical violence in the past 6 months, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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. Sh

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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