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Trial registered on ANZCTR


Registration number
ACTRN12621001006831p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2021
Date registered
30/07/2021
Date last updated
30/07/2021
Date data sharing statement initially provided
30/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of a mental health app for Emergency Service Workers: the Build Back Better app
Scientific title
A pilot trial of a mental health app for Emergency Service Workers: the Build Back Better app; assessing preliminary clinical effectiveness and user preferences
Secondary ID [1] 304634 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 322562 0
depression 322563 0
wellbeing 322564 0
resilience 322565 0
Condition category
Condition code
Mental Health 320181 320181 0 0
Anxiety
Mental Health 320182 320182 0 0
Depression
Public Health 320183 320183 0 0
Health service research
Public Health 320184 320184 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study aims to explore the use and preferences of emergency service workers regarding potential uptake of a smartphone-based Mental Health (MH) intervention providing evidence-based prevention strategies for mental distress for Emergency Service Workers in Australia. The preliminary effectiveness for whether the smartphone-based MH intervention leads to any improvement in outcomes such as distress, wellbeing and common mental disorders will furthermore be explored. The smartphone application is intended to be used in a larger scale study aimed at promoting mental health and wellbeing within Emergency Service Workers (ESWs) and their families.

A 3-month single-arm study design will be used in this pilot study to examine the feasibility and acceptability of this smartphone-based MH interventions among a sample of 63 Emergency Service Workers (ESWs) (18 years and older) in Australia. Baseline assessment will occur immediately after participants consent to participate in the study. Participants will then download the app and use it daily for approximately 21 days. Participant will be encouraged to use the app daily for a minimum of 15 minutes each day. Post-intervention assessment will occur 4 weeks (1 month) after baseline.

This pilot study will involve two key phases: Phase 1 will focus on exploring the feasibility and acceptability of this novel, purpose-built smartphone app, which will include the administration of usability and user experience surveys and qualitative interviews. The secondary objectives of Phase 2 are to describe app usage patterns (i.e. number of logins, time spent using the app) to help identify patterns in how participants engage with the smartphone application, and provide preliminary evidence for participant reported clinical outcomes (such as alcohol and other drug use, self-reported recovery, and mental health), collected via user experience surveys, qualitative interviews and in -app. Usage Information which will be passively collected whilst users engage with the application (i.e. does not require any direct data collection).

The Build Back Better app has been developed by researchers from Workplace Mental Health Team, Black Dog Institute, UNSW, and has been adapted from HeadGear, a smartphone application based on recognised and evidence-based psychological approaches including psychoeducation, behavioural activation, value-driven activity planning, goal-setting, and coping skill development and mindfulness. The Build Back Better app content and visual presentation has been modified to be suitable for Emergency Service Workers (ESWs) and their families, i.e. targeting depression, anxiety and Post Traumatic Stress Disorder (PTSD) complaints. The Build Back Better is designed for day -to- day use, and similar to HeadGear, the app content in Build Back Better is presented in the form of videos (and voiceovers), audio-recordings, and activities, providing the user with proven effective psychological approaches including problem solving, behavioural activation, mindfulness and grounding tasks, all designed to upskill users and promote wellbeing. In -app activities are including guided mindfulness exercises; value-driven activity planning, goal-setting and review; coping skill development (i.e. interactive role playing task regarding: problem solving, improving sleep, grounding methods, alcohol use, assertiveness, and training in thought managing/challenging) and also a mood monitoring widget. Different from Headgear, the app Build Back Better furthermore tailors functionalities and content based on user preferences; i.e. what complaints users are currently experiencing and what they would like to work on in this app.



Intervention code [1] 320981 0
Prevention
Intervention code [2] 320982 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328066 0
Psychological distress change as measured by the Kessler Psychological Distress Scale (K10)
Timepoint [1] 328066 0
Measurements will be collected at baseline and 4 weeks post-baseline.
Secondary outcome [1] 397433 0
Depression symptom change as measured by the patient health questionnaire (PHQ-9).
Timepoint [1] 397433 0
Measurements will be collected at baseline and 4 weeks post-baseline.
Secondary outcome [2] 397434 0
Anxiety symptom change as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Timepoint [2] 397434 0
Measurements will be collected at baseline and 4 weeks post-baseline.
Secondary outcome [3] 397435 0
Wellbeing change as measured by the WHO (Five) Well-being Index (WHO5).
Timepoint [3] 397435 0
Measurements will be collected at baseline and 4 weeks post-baseline.
Secondary outcome [4] 397436 0
Change in self-efficacy perceptions for coping with challenges and threats over time as measured by the Coping Self-Efficacy Scale (CSE-T).
Timepoint [4] 397436 0
Measurements will be collected at baseline and 4 weeks post-baseline.
Secondary outcome [5] 397437 0
App acceptability as measured by app usage and a composite set of open feedback items via a study-specific questionnaire.
Timepoint [5] 397437 0
Measurements will be collected at 4 weeks post-baseline.
Secondary outcome [6] 399049 0
Semi-structured qualitative interviews to assess study feasibility and user-acceptability, will be conducted either in person or virtually (i.e., using telephone or videoconference), depending on the COVID-19 restrictions at the time of the interviews
Timepoint [6] 399049 0
Measurements will be collected at 4 weeks post-baseline.

Eligibility
Key inclusion criteria
To be included in the study participants must:
- Be over 18 years of age
- Currently, or previously (i.e. in the last 2 years) have been working as an emergency service worker
- Reside in Australia
- Have satisfactory English comprehension
- Own a smartphone (i.e. a mobile phone that can access the Internet)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- No smartphone ownership
- Under 18 years of age
- Inability to understand English

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analysed via descriptive statistics derived from participants’ smartphone use data to characterise feasibility and acceptability in the pilot study. Pearson product-moment correlation coefficients will be used to examine the association between baseline continuous variables and application use (i.e., days used, number of times used per day). Spearman’s rank correlation coefficients will be used to examine the association between categorical variables (i.e. gender) and application use. Changes in participants’ wellbeing and mental health levels from baseline to post-test will be examined using paired sample t-tests (i.e. primary and secondary outcomes).

Qualitative data collected through semi-structured focus group will be analysed using an inductive thematic analysis approach. This approach is data-driven, and involves becoming familiar with the data, generating initial codes, searching for themes among codes and refining themes to better fit the data.

Based on review of the available literature of earlier comparable (pilot) studies using eHealth interventions, a sample size of N = 63 is required to detect a small within group effect difference (d = 0.3) with a 80% power with a 0.05 significance level. With expectation of 30% of participants to be found to be unsuitable or lost to follow-up, drop-outs, and noncompliance, at least 63 participants will need to be enrolled.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA

Funding & Sponsors
Funding source category [1] 308993 0
Government body
Name [1] 308993 0
Australian Government Department of Health
Address [1] 308993 0
GPO Box 9848
Canberra ACT 2601
Country [1] 308993 0
Australia
Primary sponsor type
Other
Name
Blackdog Institute
Address
Hospital Rd, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 309931 0
University
Name [1] 309931 0
University of New South Wales
Address [1] 309931 0
UNSW Sydney, NSW 2052.
Country [1] 309931 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308886 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 308886 0
The University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 308886 0
Australia
Date submitted for ethics approval [1] 308886 0
24/05/2021
Approval date [1] 308886 0
Ethics approval number [1] 308886 0

Summary
Brief summary
Our research team has been funded by the Australian Government Department of Home Affairs to provide a suite of integrated mental health resources for individuals affected by the 2019/2020 bushfires (emergency service workers and their families), including an app-based prevention intervention tailored to the needs of this population.

This pilot study aims to examine the feasibility of a smartphone application: Build Back Better; in providing evidence-based prevention strategies for anxiety, depression and PTSD for Emergency Service Workers and their adult family. The preliminary effectiveness for whether the intervention leads to any improvement in outcomes such as distress, wellbeing and common mental disorders will furthermore be explored. Participants will complete assessments at baseline and 1 month post- baseline.

The smartphone application is intended to be used in a larger scale study aimed at promoting mental health and wellbeing within Emergency Service Workers and their families.

The research questions/hypothesis that this study seeks to address are:
1. Explore the engagement with the components the app?
2. Explore the level of satisfaction with the app?
3. Explore the preferences of these individuals in terms of app content, format and design?
4. Explore the preliminary effectiveness in terms of improvements in wellbeing and symptom reduction? These include changes in alcohol and other drug use; self-reported recovery; health-related quality of life and mental health symptoms.

Trial website
https://www.blackdoginstitute.org.au/bush-fire-support-service/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112218 0
Prof Samuel Harvey
Address 112218 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 112218 0
Australia
Phone 112218 0
+61 2 93828356
Fax 112218 0
Email 112218 0
s.harvey@unsw.edu.au
Contact person for public queries
Name 112219 0
Dr Denise Meuldijk
Address 112219 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 112219 0
Australia
Phone 112219 0
+61 2 9065 9103
Fax 112219 0
Email 112219 0
d.meuldijk@unsw.edu.au
Contact person for scientific queries
Name 112220 0
Dr Denise Meuldijk
Address 112220 0
Black Dog Institute
Hospital Rd, Randwick NSW 2031
Country 112220 0
Australia
Phone 112220 0
+61 2 9065 9103
Fax 112220 0
Email 112220 0
d.meuldijk@unsw.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
As this is a pilot version of the smartphone application: Build Back Better, individual participant data will be used to establish feasibility and acceptability, and to inform modifications to the app before it is implemented in a large-scale trial. For this reason, individual data from the present study will not be made publicly available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results