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A Randomized Controlled Trial of a Smartphone App for addressing distress and wellbeing in a high-trauma risk population

A Randomized Controlled Trial of a Smartphone App for addressing distress and wellbeing in a high-trauma risk population

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001324707
Enrollment
880
Registered
2022-10-12
Start date
2023-03-17
Completion date
2023-08-25
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to examine the efficacy of a smartphone application [the Build Back Better app] in providing evidence-based prevention strategies for psychological distress, anxiety, depression, and posttraumatic stress (PTS) symptoms in people who have experienced potentially traumatic experiences. Based on user feedback of a previously conducted feasibility pilot study (Meuldijk et al. 2022, in preparation) within a sample of Emergency Service Workers (ESWs) (n=63) the Build Back Better app has been refined and a fully functional version is ready for formal testing in a randomized controlled trial (RCT).

Interventions

Participants will be randomised to one of two smartphone applications: 1) the intervention app (Build Back Better App- Intervention) or 2) a control Mood Monitoring application (Build Back Better App - Control). The Intervention condition: Build Back Better App The app: Build Back Better, was developed by researchers from the Workplace Mental Health Research Team at the Black Dog Institute and University of New South Wales (UNSW, Randwick, Australia) designed to reduce symptoms of common ment

Participants will be randomised to one of two smartphone applications: 1) the intervention app (Build Back Better App- Intervention) or 2) a control Mood Monitoring application (Build Back Better App - Control). The Intervention condition: Build Back Better App The app: Build Back Better, was developed by researchers from the Workplace Mental Health Research Team at the Black Dog Institute and University of New South Wales (UNSW, Randwick, Australia) designed to reduce symptoms of common mental health disorders such as anxiety, depression and distress, and increase overall wellbeing. The app Build Back Better has been adapted from a previously developed app, HeadGear, a smartphone application-based intervention centred on behavioural activation and mindfulness therapy, designed to prevent depression and anxiety and improve wellbeing amongst workers in male-dominated industries (MDIs) (Deady et al., 2020)). Similar to HeadGear, the Build Back Better app focuses on the delivery of evidence-based therapy techniques through in-app activities such as psychoeducational videos, cognitive challenging, mindfulness exercises, value-driven activity planning, goal-setting, and coping skill development (gratitude, problem solving, sleep hygiene, grounding, alcohol reduction, assertiveness) presented in the form of videos (and voiceovers), audio tracks or activities. Other components of the app include a mood monitoring widget and support service helplines. The Build Back Better app-content is designed for day-to-day use, tailored to the needs of emergency service workers population incorporating app design preferences identified by this population. The app-content is tailored by the individual based upon user preferences, i.e. what complaints users are currently experiencing and what they would like to work on in the app. Participants in the intervention condition will be encouraged to engage with the app for around 10-15min each days for at least 4 consecutive weeks (the time period between baseline and post- assessment). After completion of final assessment (the 3 month assessment) participants will be encouraged to keep using the app. Engagement with the app will be monitored throughout the study by automatically records of: number of times App opened, number of ‘app-activities’ completed, number and level of mood logged, total time spent in App. However no active adherence strategies will be used to improve app engagement during the trial. Between August 2021 and December 2021, a pilot research study (Meuldijk et al. 2022, in preparation) was conducted to examine feasibility and efficacy of the smartphone app Build Back Better among a sample of ESWs (n=63) recruited directly from rural firefighters, disaster response, surf lifesaving, police, and corrections services across four Australian states and territories. Approval was obtained from UNSW Research Ethics Committee [UNSW HREC Reference number HC210399] all participants provided informed consent. The results of this pilot study helped to refine the app design and informed progression to the main trail.

Sponsors

University of New South Wales (UNSW)
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria are as follows and will be determined by an online self-reported screening survey. Participants will be deemed eligible if they: • Are 18 years or older • Reside in Australia • Have satisfactory English comprehension • Currently, or previously (i.e. in the last 2 years) have been working as an emergency service worker • Own and have access to a smartphone • Experienced at least mild psychological distress (in the past 4 weeks)

Exclusion criteria

If not meeting the above stated inclusion criteria. - No smartphone ownership - Under 18 years of age - Inability to understand English - Not experiencing mild, moderate or severe psychological distress in the past 4 weeks

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026