Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001141831
Ethics application status
Approved
Date submitted
13/07/2021
Date registered
23/08/2021
Date last updated
12/09/2022
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of SOLAR-m: A low-intensity, brief, psychosocial intervention for firefighters delivered via smartphone
Scientific title
A randomised controlled trial of SOLAR-m: A low-intensity, brief, psychosocial intervention for firefighters delivered via smartphone designed to promote recovery and wellbeing following trauma exposure
Secondary ID [1] 304644 0
None
Universal Trial Number (UTN)
Trial acronym
SOLAR-m
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety symptoms 322587 0
Depression symptoms 322588 0
PTSD symptoms 322589 0
Work-related performance and work-family conflict 322817 0
Condition category
Condition code
Mental Health 320204 320204 0 0
Other mental health disorders
Mental Health 320585 320585 0 0
Depression
Mental Health 320586 320586 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Skills For Life Adjustment and Resilience (SOLAR) program is a brief, psychosocial, skills based intervention designed to promote recovery and maintain wellbeing following stressful events. SOLAR is typically delivered face-to-face by non-mental health professionals. The aim of this project is to conduct a randomised controlled trial to assess whether a smartphone-based version of the SOLAR intervention, known as SOLAR-m, is more effective than a control app comparator. The SOLAR mobile (SOLAR-m) app has been culturally adapted for firefighters, and participants in this RCT will be firefighters experiencing distress. The intervention period will last for five weeks, both active and control interventions will be self-paced and will be carried out at a location(s) of each participant’s choosing, as they will be delivered entirely via smartphone app and telephone calls. Participants randomised to the Skills For Life Adjustment and Resilience (SOLAR) intervention will receive access to the SOLAR smartphone app (SOLAR-m). SOLAR-m consists of eight modules delivered in animations, videos, activities, and notifications, that participants can self-complete at their own pace. The SOLAR program comprises elements drawn from evidence-based treatments for individuals experiencing trauma-related mental health problems. Most are focused on behavioural skill development or psychoeducation, with one module on cognitive strategies. These elements include components on psychoeducation about healthy living, information about keeping relationships healthy, values-based behavioural activation, arousal and affective management, expressive writing to reduce arousal associated with stress or trauma, and dealing with worry and rumination. The specific contents of each module are as follows. Module 1: Welcome to SOLAR introduces participants to the program. Module 2: Healthy Body, Healthy Mind provides tips for improved nutrition, alcohol use, sleep and exercise. Module 3: Managing Strong Emotions offers behavioural and cognitive strategies for managing stress and other overwhelming feelings, including understanding your signs of stress and relaxation activities. Module 4: Living the Life You Value helps participants to identify the life areas and activities they value and builds a plan to make time for these things. Module 5: Managing Healthy Relationships presents effective communication strategies and ways to make time for relationships in times of stress. Module 6: Getting Control Over Your Thoughts provides participants with skills to manage rumination; including mindfulness, doing distracting activities, putting worries aside until a prescribed time and either effective problem solving or accepting that the situation cannot be changed. Module 7: Coming to Terms with Difficult Experiences is an expressive writing activity that focuses on working through distressing events from the past or present. Module 8: Planning for the Future summarises the program and prompts participants to create a personalised plan for including the skills and activities they have learnt in the SOLAR in their future life. The SOLAR program content has been modified so that it can be delivered in a smartphone app, and so that it is suitable for Fire and Rescue New South Wales (FRNSW) members who are experiencing distress as a result of disaster as well any other longer term stressors. Previous and study-specific co-design work with this population has informed our adaptations, as well as work in other high risk first responder organisations. The participants will be encouraged to complete homework activities to ensure that they are able to continue with these adaptive skills once they have completed the program. Participants will also be offered a weekly check-in with a telephone facilitator who will offer support and assistance with their progression through the program. Telephone facilitators will be non-mental health professionals who have some formal training in mental health (e.g. masters level students). They will be required to undergo structured training using a facilitator guide and will be supervised by a psychologist in weekly group supervision throughout the study. Once telephone facilitators have seen two participants through a full course of the SOLAR program and have had their practice supervised during this time, they will be accredited. Treatment adherence will be assessed using app metadata, including rates of completion of the app. Facilitators will also be in regular contact with participants to support them to use the app as intended.
Intervention code [1] 321008 0
Treatment: Other
Intervention code [2] 321287 0
Behaviour
Comparator / control treatment
Participants randomised to the control condition will receive access to a control app, which has been custom-designed for this project. The control app will provide daily mood monitoring, psychoeducation about stress and trauma, and crisis support. Participants will be prompted to record their mood once per day for the 5 week period. They will have a set-up phone call with a facilitator to get them started, and have access to weekly telephone calls if they desire. Every 7 days, participants will be prompted to review their weekly mood charts based on the data they have input over the previous week. If participants report a negative mood, they will be prompted to use certain features of the app, namely, crisis support, and psychoeducation on stress, trauma, and strong emotions.
Control group
Active

Outcomes
Primary outcome [1] 328092 0
Change in depression subscore of the Hospital Anxiety and Depression Scale (HADS) (measuring depression symptoms) from pre- (T1) to post-intervention (T2 and T3) in the intervention group compared to the control group
Timepoint [1] 328092 0
At commencement of the intervention period (Time 1), 2-4 weeks following completion of the intervention (Time 2 - primary timepoint), 3 months after the intervention (Time 3)
Primary outcome [2] 328093 0
Change in anxiety subscore of the Hospital Anxiety and Depression Scale (HADS) (measuring anxiety symptoms) from pre- (T1) to post-intervention (T2 and T3) in the intervention group compared to the control group
Timepoint [2] 328093 0
At commencement of the intervention period (Time 1), 2-4 weeks following completion of the intervention (Time 2 - primary timepoint), 3 months after the intervention (Time 3)
Primary outcome [3] 328409 0
Change in PTSD Checklist for DSM-5 (PCL-5) score (measuring PTSD symptoms) from pre- (T1) to post-intervention (T2 and T3) in the intervention group compared to the control group
Timepoint [3] 328409 0
At commencement of the intervention period (Time 1), 2-4 weeks following completion of the intervention (Time 2 - primary timepoint), 3 months after the intervention (Time 3)
Secondary outcome [1] 397613 0
Credibility Expectancy Questionnaire (CEQ-II) score (measuring treatment expectations) in the intervention group compared to the control group
Timepoint [1] 397613 0
At commencement of the intervention period (Time 1)
Secondary outcome [2] 397614 0
Change in Work Family Conflict (WFC) score (measuring work-family conflict) from pre- (T1) to post-intervention (T2 and T3) in the intervention group compared to the control group
Timepoint [2] 397614 0
At commencement of the intervention period (Time 1), 2-4 weeks following completion of the intervention (Time 2), 3 months after the intervention (Time 3)
Secondary outcome [3] 397615 0
Change in Health and Work Performance Questionnaire (HPQ) score (measuring the workplace cost of health problems) from pre- (T1) to post-intervention (T2 and T3) in the intervention group compared to the control group
Timepoint [3] 397615 0
At commencement of the intervention period (Time 1), 2-4 weeks following completion of the intervention (Time 2), 3 months after the intervention (Time 3)

Eligibility
Key inclusion criteria
To be eligible for the study, participants need to be a current or retired retained (volunteer) or full-time firefighter with Fire & Rescue NSW, aged over 18, own an internet connected smartphone and be willing to download and use an app for the duration of the study. They must also be experiencing mild to moderate distress, as assessed by the 6-item Kessler Psychological Distress Scale (K6). If participants score between 7 and 18 on the K6 they are eligible for this study. If participants score greater than or equal to 19 on the screener, they will be eligible to participate in the SOLAR-m trial however, they will first be offered a more structured form of clinical treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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 is concealed as it will be carried out digitally, when participants download the app to their smartphone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation - participants will be allocated by computer software when they download the app
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined based on detecting a small-moderate effect size in the intervention group at post-treatment, based on prior research using SOLAR. In order to detect a 0.4 difference in effect size with 0.80 power and an alpha of 0.05, an N of 200 is required. To account for attrition (20%), sample size is inflated to 240.

Baseline characteristics of the SOLAR-m and control groups will be tabulated using appropriate summary statistics. We will determine whether there are any significant differences between current and retired firefighters on primary T1 measures. Any differences will then be controlled for in subsequent analyses. Subsequent stages of analyses will involve regression, between-subject analysis of covariance and its variants, within-subjects analyses of change and non-parametric analyses (depending on the level of analysis and distribution of outcome variables). Statistical analyses of participants completing treatment will include:
- Comparison of SOLAR-m and the control groups' reduction in symptom severity on primary outcome measures (PCL-5 and HADS), including measures of effect size
- Comparison of SOLAR-m and the control groups' change over time on secondary outcome measures (Work-Family Conflict measure and Health and Work Performance questionnaire), including measures of effect size
- Correlational analysis to assess the association of treatment expectations (CEQ-II) with treatment outcomes
- Descriptive analysis of app usage data to understand client throughput, app usage patterns and engagement.
These analyses will help us to understand the presentation of mental health issues across the two groups and how they engaged with the study app. Missing data will be handled using a range of suitable techniques including full information likelihood, multiple imputation and, where power and missing data patterns afford, listwise deletion.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
15/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309021 0
Commercial sector/Industry
Name [1] 309021 0
icare Foundation
Country [1] 309021 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Phoenix Australia
Address
Level 3, Alan Gilbert Building, 161 Barry Street, Carlton, VIC 3053
Country
Australia
Secondary sponsor category [1] 309958 0
None
Name [1] 309958 0
Address [1] 309958 0
Country [1] 309958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308894 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 308894 0
Ethics committee country [1] 308894 0
Australia
Date submitted for ethics approval [1] 308894 0
26/03/2021
Approval date [1] 308894 0
21/06/2021
Ethics approval number [1] 308894 0
2021-20632-18826-5

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

Contacts
Principal investigator
Name 112250 0
Prof Meaghan O'Donnell
Address 112250 0
Phoenix Australia
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton
VIC 3054
Country 112250 0
Australia
Phone 112250 0
+61 3 9035 7883
Fax 112250 0
Email 112250 0
[email protected]
Contact person for public queries
Name 112251 0
Meaghan O'Donnell
Address 112251 0
Phoenix Australia
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton
VIC 3054
Country 112251 0
Australia
Phone 112251 0
+61 3 9035 7883
Fax 112251 0
Email 112251 0
[email protected]
Contact person for scientific queries
Name 112252 0
Meaghan O'Donnell
Address 112252 0
Phoenix Australia
Level 3, Alan Gilbert Building, 161 Barry Street
Carlton
VIC 3054
Country 112252 0
Australia
Phone 112252 0
+61 3 9035 7883
Fax 112252 0
Email 112252 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.