Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001547730
Ethics application status
Approved
Date submitted
22/11/2022
Date registered
14/12/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
14/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
National implementation of Minds Together, an online program for family and friends supporting the mental health of paramedics.
Scientific title
A pilot randomised controlled study of an online intervention for family and friends supporting a paramedic experiencing mental ill-health or suicidal distress.
Secondary ID [1] 307971 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental ill-health 327633 0
suicidal distress 327634 0
carer burden 327635 0
Condition category
Condition code
Mental Health 324720 324720 0 0
Anxiety
Mental Health 324721 324721 0 0
Depression
Mental Health 324722 324722 0 0
Suicide
Mental Health 324723 324723 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Minds Together is a suite of programs developed by Everymind that aim to improve the capacity of caregivers to support family and friends experiencing mental ill-health or suicidal distress. The current project will evaluate the feasibility and acceptability of the newest program, an online intervention for family and friends supporting a paramedic experiencing mental ill-health or suicidal distress.
Everymind has developed a prevention and early-intervention program for carers of individuals experiencing depression and anxiety, and has adapted this program for carers of paramedics. We are proposing to evaluate the effectiveness and implementation potential of the adapted Minds Together program.
This will conduct a two-arm randomised controlled trial in which carers will be randomly allocated to either a wait-list control group or to Minds Together. Follow-up online assessments will occur eight weeks from randomisation and at six months from randomisation. The intervention group who complete a six-month follow up survey will be invited to participate in an Zoom/telephone interview. Mixed methods analyses will be used to examine the reach, adoption, implementation and maintenance of the program.

PROGRAM OVERVIEW
- Caregivers in the Minds Together Online Support Program (the Program) will be asked to complete four (4) core sections and six (6) optional in-depth topics over an eight (8) week period.
- It is expected that each core section will take approximately 30 - 60 minutes to complete. Participants will receive each section once they have completed the proceeding section. All four sections and in-depth topics will become available after four weeks, regardless of how much of the program the participant may have completed by that time.
- Each optional in-depth topics will take 10 - 15 minutes each to complete.
- The estimated completion times for sections and in-depth topics are inclusive of activities built into the program, although this may vary for some participants based on their caregiving experiences.

SECTION CONTENT
The program sections address the following topics:
Section 1 - Supporting your family member or friend - information about suicidal distress, mental health and exploration of the caring journey for the caregiver and the person they support.
Section 2 - Looking after yourself - looking further at the caring journey and exploring caregiver wellbeing and self-care. This includes exploring the challenges and rewards of providing support, identifying how supporting someone may affect a carers own mental health, checking-in on a carers own wellbeing and learning about self-care.
Section 3 - Providing support – focusses on ways to help caregivers respond to the challenges of providing support. This includes exploring links between thoughts, feelings, body and action; learning how to notice strong feelings; learning more about communication and talking about mental ill-health.
Section 4 – Bringing it all together – focusses on bringing together all the information from the first 3 sections about mental ill-health and suicidal distress, self-care and providing support. This includes learning how to identify and respond to stigma, how to identify a support network, and exploring common scenarios and practical advice.
In-depth topics - will go into further depth on topics discussed in core sections, including information on stigma, self-care, responding to suicidal distress, talking about suicide, relationships, and values.
- Participants will receive weekly emails reminding them of access details and prompting completion of the sections and mini-sections.

PROGRAM DESIGN
- The Program has been specifically designed by Everymind for this online intervention. It builds on several previous Everymind programs, and is dedicated to strengthening the capacity and capability of family and friends as caregivers and promote their own mental health and wellbeing.
- The program is delivered online using a mixed-media format, including text, short videos, infographics, and short podcasts.
- Each section contains case studies, activities, worksheets, and reflective questions that caregivers can answer within the program and at a time that suits the participant.
- No grade will be given for any of the exercises.
- Caregivers will also have the capacity to download activities and information sheets for future use via a ‘toolbox’ feature.

SOCIAL FORUM
Everymind has contracted SANE to provide the online social forum for the Minds Together study. SANE run one of Australia’s largest online social support forums for caregivers of mental ill-health and suicidal distress. The moderated forum is a supportive community where users can chat with others in similar situations. Participant use of the social forum is completely optional and will be at participants' discretion. The forums are also extremely well managed by SANE, with entrenched privacy, community guidelines and moderation. SANE will retain administrative control over the forum.
Intervention code [1] 324437 0
Behaviour
Intervention code [2] 324438 0
Prevention
Comparator / control treatment
The control group will be placed on a waitlist and will receive access to the program following an 8-week waiting period.
Control group
Active

Outcomes
Primary outcome [1] 332572 0
Change in caregiver burden (measured using the BSFC-s Burden Scale for family caregivers).
Timepoint [1] 332572 0
baseline, eight (8) weeks after randomisation, six months after randomisation.
Primary outcome [2] 333167 0
Change in caregiver coping self-efficacy (measured using the Coping Self-efficacy Scale [CSE]).
Timepoint [2] 333167 0
Eight (8) weeks post-randomisation, six months after randomisation.
Primary outcome [3] 333325 0
Change in caregiver perception of social support (measured using the Perceived Social Support Questionnaire [F-SozU K6]).
Timepoint [3] 333325 0
Eight (8) weeks post-randomisation, six months after randomisation.
Secondary outcome [1] 413957 0
Change in psychological distress in caregivers (measured using the Patient Health Survey–9 [PHQ-9] and brief Generalised Anxiety Disorder measure [GAD-7].
Timepoint [1] 413957 0
Baseline, eight (8) weeks post-randomisation, six months after randomisation.
Secondary outcome [2] 416013 0
change in caregiver quality of life (across 7 domains) measured using the Carer Quality of Life (QOL) instrument.
Timepoint [2] 416013 0
Baseline, eight (8) weeks post-randomisation, six months after randomisation.
Secondary outcome [3] 416014 0
Change in caregiver’s ability to work and perform regular activities to be measured using the Work Productivity and Activity Impairment Questionnaire.
Timepoint [3] 416014 0
Baseline, eight (8) weeks post-randomisation, six months after randomisation.
Secondary outcome [4] 416015 0
Program satisfaction to be measured using a seven (7) item study-specific satisfaction measure. Participants will rate their satisfaction with program features, across seven (7) domains, using a five-point Likert scale (not at all, a little bit, neutral, somewhat, a lot), as well as telephone/Zoom interviews.
Timepoint [4] 416015 0
Six months after randomisation.
Secondary outcome [5] 416016 0
Survey adherence rates to be measured using REDCap metadata.
Timepoint [5] 416016 0
Baseline, eight (8) weeks post-randomisation, six months after randomisation.
Secondary outcome [6] 416017 0
Program completion rates to be measured using website metadata.
Timepoint [6] 416017 0
Six months after randomisation.
Secondary outcome [7] 416018 0
Study safety to be measured using website and REDCap metadata.
Timepoint [7] 416018 0
Six months after randomisation.

Eligibility
Key inclusion criteria
- Adults (>18 years of age)
- A family member or friend supporting a currently employed or previously employed paramedic experiencing mental ill-health or suicidal distress. The person being supported does not need to have a formal mental health diagnosis.
- Currently resides in Australia
- Is comfortable reading and writing in English
- Has access to a computer and is comfortable using web-based programs.
Family members or friends (supporting a paramedic) who are currently experiencing high levels of distress should consider whether this is an appropriate time to participate in this program. Other appropriate options may be seeking one-on-one support with a mental health professional or psychologist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- anyone who has previously accessed the Minds Together online program for family and friends supporting someone experiencing depression or anxiety should not complete this program.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
- A third-party researcher, not privy to participant data, will create an allocation table, which will be uploaded to REDCap.
- Participants self-identify if eligible for the study via a screening survey in REDCap. If eligible, they then are automatically directed to complete the baseline survey in REDCap.
- Once participants have completed the baseline survey, researchers will click the 'randomise' button for each de-identified participant in REDCap, to randomly assign them to one of the groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess program feasibility, the program adherence rates, survey adherence rates, program completion rates and study safety will be assessed across the study period using REDCap and website metadata.
- Program Adherence will be defined as participants who activated their online program accounts and will be assessed using website metadata. An adherence goal of 50% has been set as criteria, based on literature documenting high attrition rates for online health interventions.
- Likewise, Survey Adherence will be defined as participants who completed their post-program survey and will be assessed using REDCap metadata. An adherence goal of 50% has been set as criteria.
- Program Completion will be defined as participants who clicked on every page of at least the two core modules. This equates to roughly 50% of the online content and matches the commonly referred to threshold for program completion in online health interventions. This will be assessed using website metadata.
- Study safety will be defined as no feedback from participants regarding their distress from engaging with the study. The study will also be considered safe if participant K10 or SIDAS scores did not increase across timepoints. Study Safety will be assessed logging participant feedback throughout the study period, and using REDCap data across all timepoints.

Program Acceptability
- To assess program acceptability, the participant satisfaction rates will be calculated and will be assessed across the study period using REDCap data and qualitative data.
- Program satisfaction will be defined as most participants being somewhat or a lot satisfied with program features and will be assessed using REDCap data.
- Satisfaction will be measured using a seven (7) item study-specific satisfaction measure. Participants will rate their satisfaction with program features, across seven (7) domains, using a five-point Likert scale (not at all, a little bit, neutral, somewhat, a lot).
- Program satisfaction will also be assessed using a semi-structured post-program interview, based on the program satisfaction questions explored in the post-program survey. Satisfaction will be defined as most participants making positive appraisals about the program.
- Researchers will code interview responses using Nvivo data analysis software. Researchers will cross-check and discuss results to determine overall program satisfaction domains and summarise the number of participant comments for each program satisfaction domain.

Outcome Measures
The feasibility of outcome measures will be assessed using Intention-to-Treat analysis of caregiver strain and coping self-efficacy scores over time. Intention to Treat analysis of effect over time will also be performed with linear mixed modelling.

Hierarchical linear models will evaluate between-group differences in primary and secondary outcomes. The group variable and the baseline value of the outcome of interest will be entered as fixed effects into the model. Intercepts and slopes for participants will be entered as random effects. Maximum likelihood estimation will be used for missing data. Residual plots will be used to assess deviations from homoscedasticity or normality. All analyses will use a significance level of 5%.

Data collected to evaluate the potential implementation of the program based on the RE-AIM framework will be analysed using means (standard deviation) for continuous variables, and counts and percentages for categorical variables. Group comparisons will be carried out using Student’s t-test and ?2 tests. Text data will be analysed using an inductive content analysis.
From telephone or Zoom interviews, interview data will be analysed using thematic analysis.
Data collected to evaluate the potential implementation of the program based on the RE-AIM framework will be analysed using means (standard deviation) for continuous variables, and counts and percentages for categorical variables. Group comparisons will be carried out using Student’s t-test and ?2 tests. Text data will be analysed using an inductive content analysis.

From telephone or Zoom interviews, interview data will be analysed using thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/11/2022
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
130
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312240 0
Charities/Societies/Foundations
Name [1] 312240 0
Movember and The Distinguished Gentleman’s Ride – Veterans and First Responders Mental Health Grant Program
Country [1] 312240 0
Australia
Primary sponsor type
Government body
Name
Everymind
Address
James Fletcher Campus
72 Watt Street
Newcastle, NSW 2300
Country
Australia
Secondary sponsor category [1] 313841 0
None
Name [1] 313841 0
Address [1] 313841 0
Country [1] 313841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311616 0
Hunter New England Human Research Ethics Committee of Hunter New England Local Health District
Ethics committee address [1] 311616 0
Ethics committee country [1] 311616 0
Australia
Date submitted for ethics approval [1] 311616 0
09/11/2022
Approval date [1] 311616 0
14/11/2022
Ethics approval number [1] 311616 0
2022/ETH02317

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

Contacts
Principal investigator
Name 121730 0
Dr Sally Fitzpatrick
Address 121730 0
Everymind
James Fletcher Campus
72 Watt Street
Newcastle, NSW 2300
Country 121730 0
Australia
Phone 121730 0
+61 249246945
Fax 121730 0
Email 121730 0
[email protected]
Contact person for public queries
Name 121731 0
Philippa Ditton-Phare
Address 121731 0
Everymind
James Fletcher Campus
72 Watt Street
Newcastle, NSW 2300
Country 121731 0
Australia
Phone 121731 0
+61 249246900
Fax 121731 0
Email 121731 0
[email protected]
Contact person for scientific queries
Name 121732 0
Jose Cuenca
Address 121732 0
Everymind
James Fletcher Campus
72 Watt Street
Newcastle, NSW 2300
Country 121732 0
Australia
Phone 121732 0
+61 249246900
Fax 121732 0
Email 121732 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.