Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001324707
Ethics application status
Approved
Date submitted
7/09/2022
Date registered
12/10/2022
Date last updated
25/02/2024
Date data sharing statement initially provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized Controlled Trial of a Smartphone App for addressing distress and wellbeing in a high-trauma risk population
Scientific title
A Randomized Controlled Trial of a Smartphone App for addressing distress and wellbeing in a high-trauma risk population
Secondary ID [1] 307755 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
A pilot trial was done before the main trial, Trial Id: ACTRN12621001006831 - designed to support the development of this definitive RCT of the current registration

Health condition
Health condition(s) or problem(s) studied:
anxiety 327566 0
depression 327567 0
trauma 327568 0
general distress 327569 0
wellbeing 327578 0
resilience 327579 0
Condition category
Condition code
Mental Health 324654 324654 0 0
Anxiety
Mental Health 324655 324655 0 0
Depression
Mental Health 324656 324656 0 0
Other mental health disorders
Public Health 324664 324664 0 0
Health service research
Public Health 324665 324665 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324378 0
Early detection / Screening
Intervention code [2] 324379 0
Prevention
Intervention code [3] 324380 0
Treatment: Devices
Comparator / control treatment
The control condition: Mood Monitoring Smartphone Application
The control condition is a smartphone application that, to the user, will have the same name and a virtually identical look and ‘feel’ as Build Back Better. However, the content that is focused on Cognitive Behavioural Therapy (CBT); components of value-driven action, positive psychology, mindfulness therapy and healthy coping techniques, is not presented. The control condition will solely include elements of mood- and activity-monitoring, encouraging the users to monitor their mood and activities daily over the duration of the research trial. Furthermore, users are able to review their ‘tracking history’ in a graph that displays the mood and activity recorded across each day.

Participants will be encouraged to engage with the app for around 10-15 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.

Participants in the control condition will be offered the opportunity to download, and have access to, the Build Back Better App (full version) after this final assessment.
Control group
Active

Outcomes
Primary outcome [1] 332471 0
Kessler Psychological Distress Scale (K10). The Kessler Psychological Distress Scale (K10) (Slade et al., 2011).The K10 is a 10-item measure of psychological distress over the past 4 weeks and intended to yield a global measure of distress based on questions about anxiety and depressive symptoms. The K10 uses a five-value response option for each question – ‘all of the time, most of the time, some of the time, a little of the time’ and none of the time’; which can be scored from five through to one. The total K10 score is based on the sum of the answers given to the ten questions and will be used to indicate psychological distress across all study time-points. The maximum score is 50 indicating severe distress, the minimum score is 10 indicating no distress.
Timepoint [1] 332471 0
Kessler Psychological Distress Scale (K10) will be collected at three timepoints; 1) Screening/Baseline; 2) one month (i.e. 4 weeks) post baseline (primary timepoint) and 3) three months (13 weeks) after baseline.
Secondary outcome [1] 413650 0
Depressive symptoms. Patient Health Questionnaire (PHQ-9) (Löwe, Kroenke, Herzog, & Gräfe, 2004).The PHQ-9 is a 9-item self-report tool designed to assess depression severity. The items duplicate the nine diagnostic criteria for major depressive disorder covered in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The PHQ-9 asks how often participants have been bothered by problems in the past 2 weeks. Each item scored on a 4-point Likert scale, ranging from 0 (“not at all”) to 3 (“nearly every day”). Items are summed to provide a total score (ranging from 0-27) and served as a marker of severity and distress across all study time-points. Scores less than or equal to 4 suggest minimal depression which may not require treatment, whereas a score of greater than or equal to 10 is indicative of depression.
Timepoint [1] 413650 0
The Patient Health Questionnaire (PHQ-9) will be collected at three timepoints; 1) Baseline; 2) one month (i.e. 4 weeks) post baseline and 3) three months (13 weeks) after baseline.
Secondary outcome [2] 413651 0
Anxiety symptoms. Generalized Anxiety Disorder- 7 item (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006).The GAD-7 is a reliable and valid seven-item measure of generalised anxiety symptoms, and it also proved to have good sensitivity and specificity as a screener for panic, social anxiety and post-traumatic stress disorder (Kroenke, Spitzer, Williams, Monahan, & Löwe, 2007). GAD-7 scores can range from 0 to 27; with 5, 10 and 15 representing mild, moderate and severe levels of anxiety symptoms. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD. Although this questionnaire is used mostly to detect one general anxiety condition, it can also help detect panic disorder, social anxiety disorder, and post-traumatic stress disorder.
Timepoint [2] 413651 0
The Generalized Anxiety Disorder- 7 item (GAD-7 will be collected at four timepoints; 1) Baseline; 2) one month (i.e. 4 weeks) post baseline and 3) three months (13 weeks) after baseline.
Secondary outcome [3] 413652 0
Wellbeing. The 5-item WHO Wellbeing Index (WHO-5) (Topp, Østergaard, Søndergaard, & Bech, 2015). The WHO-5 is a short, self-administered measure of well-being over the last two weeks. It consists of five positively worded items that are rated on 6-point Likert scale, ranging from 0 (“at no the time”) to 5 (“all of the time”). The raw scores will be transformed to a score from 0 to 100, with lower scores indicating worse well-being. A score of less than or equal to 50 indicates poor wellbeing and suggests further investigation into possible symptoms of depression
Timepoint [3] 413652 0
The 5-item WHO Wellbeing Index (WHO-5) will be collected at four timepoints; 1) Baseline; 2) one month (i.e. 4 weeks) post baseline and 3) three months (13 weeks) after baseline.
Secondary outcome [4] 413653 0
Trauma Coping Self- Efficacy (CSE-T). The CSE-T (Benight et al., 2015). is a 9-item measure of perceived self-efficacy for coping with challenges and threats. Participants are asked to rate their capability to handle a series of posttraumatic situations (e.g., “Deal with my emotions [anger, sadness, depression, anxiety] since the traumatic event,” “Manage distressing dreams or images about the traumatic experience”), on a 7-point scale ranging from 1 = ‘not at all capable’ to 7 = ‘totally capable’. The CSE-T has demonstrated psychometrically sound properties across three different samples, including hospitalized trauma patients (e.g., motor vehicle accident, interpersonal violence), natural disaster survivors (e.g., fire, hurricane), and an undergraduate population (Benight et al., 2015). Total CSE-T scores (ranging between 1 and 49) will be created by summing the item ratings, across all time points, to analyze whether CSE-T increased as participants continued to use the application (i.e. reflecting improvement in self-efficacy perceptions). Overall mean scores (ranging from 1 to 7) will furthermore be offered for ease of interpretation.
Timepoint [4] 413653 0
The Trauma Coping Self- Efficacy (CSE-T) will be collected at three timepoints; 1) Baseline; 2) one month (i.e. 4 weeks) post baseline and 3) three months (13 weeks) after baseline.
Secondary outcome [5] 413656 0
The Assessment of Quality of Life (AQoL-4D). The AQoL-4D instrument (shortened version - 12 items); is designed to measure health-related quality of life (HRQoL). The AQoL measures 5 dimensions: illness, independent living, social relationships, physical senses and psychological wellbeing. The AQol-4D has 12 items with each item consisting of 4 response levels ((Hawthorne, Richardson, & Osborne, 1999).
Timepoint [5] 413656 0

Update The AQoL-4D will be collected at three timepoints; 1) Baseline; 2) one month (i.e. 4 weeks) post baseline and 3) three months (13 weeks)) after baseline.
Secondary outcome [6] 413661 0
Brief Resilience Scale. Resilience will be measured using six items from the Brief Resilience Scale (BRS), a reliable measure of assessing the ability to recover from stress (Smith et al., 2008).
Connor-Davidson Resilience Scale 10 (CD-RISC-10). Resilience will be measured using the CD-RISC-10. The 10-item scale is comprised of ten of the original 25 items from the CD-RISC-10 scale, each item consisting of 5 [0-4] response levels. A respondent’s total score can range from 0-40 (Connor & Davidson, 2003) (Connor & Davidson, 2003).
Timepoint [6] 413661 0
The CD-RISC-10 will be collected at three timepoints; 1) Baseline; 2) one month (i.e. 4 weeks) post baseline and 3) three months (13 weeks) after baseline
Secondary outcome [7] 413662 0
Work performance. Work Performance will be measured using a single item from the Health and Work Performance Questionnaire (HPQ) (Kessler et al., 2003) and two additional items pertaining to past month sickness absence (days absent, days absent for mental health reasons).
Timepoint [7] 413662 0
The Health and Work Performance Questionnaire (HPQ) will be collected at four timepoints; 1) Baseline; 2) one month (i.e. 4 weeks) post baseline and 3) three months (13 weeks).
Secondary outcome [8] 413663 0
App- Engagement. Through a survey and semi structured interviews at post-intervention assessment, qualitative data will be gathered used to inform user-experience and satisfaction with the app. This survey includes several questions adapted from the Mobile Application Rating Scale (MARS) (Hides et al., 2014) (Hides et al., 2014), including questions measuring likelihood to recommend the app to others, overall rating, target audience, as well as three questions assessing how easy and interesting the app was to use. Further questions measure usefulness of specific app features, and suggestions for additional content.
Timepoint [8] 413663 0
This survey will be administered to all participants at the post-intervention (one month post baseline; i.e. 4 weeks) assessment.
Secondary outcome [9] 413664 0
App- Engagement. Through a survey and semi structured (qualitative) interviews, qualitative data will be gathered used to inform user-experience and satisfaction with the app. Facilitators will ask questions to guide the participant through the relevant topics (i.e. functionality; engagement; aesthetics; information exchange) whereas unanticipated ideas that will emerge in any discussion will also be pursued. The interviews 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 [9] 413664 0
These semi-structured interviews will be conducted at the post-intervention assessment (one month; i.e. 4 week post baseline) for those who participated in the intervention condition.
Secondary outcome [10] 413665 0
Objective app engagement: The app automatically records: number of times App opened, number of ‘app-activities’ completed, number and level of mood logged, total time spent in App.
Timepoint [10] 413665 0
Passive data-collection; throughout study duration

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation codes will be generated and retained automatically by the Black Dog Institute’s bespoke research engine trial software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to the intervention or control condition will occur on a 2:2 ratio using a block design (4 participants per block) using an automated web-based platform tailored for this project. Randomisation codes will be generated and retained automatically by the Black Dog Institute’s bespoke research engine trial software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The plan is to enrol 1026 subjects to complete the trial. The nominated sample is based on review of the available literature of earlier comparable studies (Goreis et al., 2020; Han et al., 2020; Rodriguez-Paras et al., 2017). Expecting a small between-group effect size (Cohen’ s d=0.20), thereby assuming an alpha of 0.05 and a power of 0.80 (ß -1), a minimum of 394 participants would be required per study arm. Allowing for a dropout rate of 30% of study participants from baseline, we will recruit 1026 into the trial (i.e. 513 participants per treatment arm). The sample size calculation was conducted by the software program G*POWER.

Primary analysis will be conducted within an intention-to-treat framework using mixed modelling to determine the effect of the intervention on psychological distress, including all participants randomised, regardless of treatment received. These analyses will be repeated for the secondary outcomes. Effect sizes will be calculated based on differences in change scores between baseline and 1 month post-test for the intervention condition versus control condition, using standard deviations of the change scores pooled across both conditions.

Qualitative data will be analysed using an inductive thematic analysis approach (Braun & Clarke, 2006). 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/11/2022
Actual
17/03/2023
Date of last participant enrolment
Anticipated
31/01/2023
Actual
25/08/2023
Date of last data collection
Anticipated
31/01/2024
Actual
5/12/2023
Sample size
Target
1026
Accrual to date
Final
1021
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312021 0
Government body
Name [1] 312021 0
Commonwealth Department of Health and Ageing
Country [1] 312021 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
UNSW Sydney, NSW 2052.
Country
Australia
Secondary sponsor category [1] 313521 0
Other
Name [1] 313521 0
the Black Dog Institute
Address [1] 313521 0
Hospital Rd, Randwick NSW 2031
Country [1] 313521 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311439 0
University of New South Wales Human Research Ethics Committee (UNSW HREC )
Ethics committee address [1] 311439 0
Ethics committee country [1] 311439 0
Australia
Date submitted for ethics approval [1] 311439 0
22/08/2022
Approval date [1] 311439 0
18/10/2022
Ethics approval number [1] 311439 0
HC220566

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

Contacts
Principal investigator
Name 121102 0
Dr Denise Meuldijk
Address 121102 0
Black Dog Institute Hospital Rd, Randwick NSW 2031
Country 121102 0
Australia
Phone 121102 0
+61 2 9065 9103
Fax 121102 0
Email 121102 0
[email protected]
Contact person for public queries
Name 121103 0
Denise Meuldijk
Address 121103 0
Black Dog Institute Hospital Rd, Randwick NSW 2031
Country 121103 0
Australia
Phone 121103 0
+61 2 9065 9103
Fax 121103 0
Email 121103 0
[email protected]
Contact person for scientific queries
Name 121104 0
Denise Meuldijk
Address 121104 0
Black Dog Institute Hospital Rd, Randwick NSW 2031
Country 121104 0
Australia
Phone 121104 0
+61 2 9065 9103
Fax 121104 0
Email 121104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.