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Trial registered on ANZCTR


Registration number
ACTRN12622001163796
Ethics application status
Approved
Date submitted
4/03/2022
Date registered
24/08/2022
Date last updated
24/08/2022
Date data sharing statement initially provided
24/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility and acceptability study of an online intervention for family and friends caring for a person who has attempted suicide.
Scientific title
A pilot randomised controlled study of an online intervention for family and friends caring for a person who has attempted suicide.
Secondary ID [1] 306598 0
Nil known
Universal Trial Number (UTN)
U1111-1275-3858
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carer Burden 325508 0
Suicide Attempt 325509 0
Condition category
Condition code
Mental Health 322882 322882 0 0
Suicide
Mental Health 322883 322883 0 0
Anxiety
Mental Health 322884 322884 0 0
Depression
Mental Health 322885 322885 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Minds Together is a suite of programs, from 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 caring for a person who has attempted suicide.

PROGRAM OVERVIEW
- Caregivers in the Minds Together Online Support Program (the Program) will be asked to complete two (2) core modules and eight (8) optional mini-modules over an eight (8) week period.
- We expect each core module to take approximately 45 - 60 minutes to complete.
- The optional mini-modules will take 15-30 minutes each to complete, depending on which in-depth topics are chosen.
- The estimated completion times for modules and mini-modules are inclusive of activities built into the program, although this may vary for some participants based on their caregiving experiences.

MODULE CONTENT
The modules address the following topics:
- Module 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.
- Module 2 – Looking after yourself - looking further at the caring journey and exploring caregiver wellbeing and self-care.
- Mini-Modules –will go into further depth on topics discussed in Modules 1 and 2, including talking about suicide, stigma, self-care, communication, safety plans, feelings and hypervigilance.
- Participants will receive weekly emails reminding them of access details and prompting completion of the modules and mini-modules.

PROGRAM DESIGN
- The Program has been specifically designed by Everymind for this online intervention. It builds on several previous Everymind programs, including Guiding Their Way Back - a series of resources and face to face training developed with Beyond Blue.
- The program is delivered online using a mixed-media format, including text, short videos, infographics, and short podcasts.
- Each module 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.

SOCIAL FORUM
- In addition to the Program, Everymind will integrate an online social support forum (the Forum), as social support has been identified as an essential factor in reducing caregivers’ poor mental health outcomes.
- The Forum is a closed discussion forum and operates similarly to a Facebook Group. Unless caregivers choose to use their names, their identities will remain anonymous. Only their first name will be visible to other users if they decide to use their name.
- Users can post their story, their thoughts, update their status, share links and images and talk to other caregivers about their experience with the program. Users can edit and remove any comments or posts they have added to the community and change the settings for the types of notifications they receive via email.
- The Forum will be moderated by a PhD student running the trial and supervised by a Clinical Psychologist.
- Participants can contribute as little or as much to the Forum as they wish; there is no minimum contribution amount.
- Participants allocated to the social forum will also receive weekly emails reminding them of access details and prompting them to log in to and participate in the social forum.
- Deidentified metadata showing what content was accessed and completed by participants when users accessed the content and for how long will be used to assess the program’s feasibility and acceptability.
Intervention code [1] 323027 0
Behaviour
Intervention code [2] 323028 0
Prevention
Comparator / control treatment
The control group will receive access to the 8 week program only (not the social support forum).
Control group
Active

Outcomes
Primary outcome [1] 332329 0
Program Feasibility - a composite outcome - assessing the program adherence rates, survey adherence rates, program completion rates and study safety 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.

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:
- 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.
Timepoint [1] 332329 0
Baseline, Eight (8) weeks after randomisation.
Primary outcome [2] 332331 0
Program Acceptability - a composite outcome - assessing the program satisfaction using REDCap survey data and qualitative survey data.

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.
Timepoint [2] 332331 0
8 weeks post-randomisation, 3 months post-intervention completion.
Secondary outcome [1] 413038 0
Caregiver strain measured using the Zarit Burden Interview (ZBI).
Timepoint [1] 413038 0
Baseline, 8 weeks post-randomisation, 3 months post-intervention completion.
Secondary outcome [2] 413039 0
Caregiver coping self-efficacy measured using the Coping Self-efficacy Scale (CSE).
Timepoint [2] 413039 0
Baseline, 8 weeks post-randomisation, 3 months post-intervention completion.
Secondary outcome [3] 413040 0
Caregiver distress measured using the Kessler Psychological Distress Scale (K10).
Timepoint [3] 413040 0
Baseline, 8 weeks post-randomisation, 3 months post-intervention completion.
Secondary outcome [4] 413041 0
Thoughts of suicide to be measured using the Suicidal Ideation Attributes Scale (SIDAS).
Timepoint [4] 413041 0
Baseline, 8 weeks post-randomisation, 3 months post-intervention completion.
Secondary outcome [5] 413042 0
Caregiver quality of life (across 7 domains) measured using the Carer QOL instrument.
Timepoint [5] 413042 0
Baseline, 8 weeks post-randomisation, 3 months post-intervention completion.

Eligibility
Key inclusion criteria
- Adults (>18 years of age)
- A family member or friend caring for an adult (>18 years of age) who has attempted suicide
- Currently resides in Australia
- Is comfortable reading and writing in English
- Has access to a computer with a reliable internet connection and is comfortable using web-based programs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The pilot study has three exclusionary criteria, which are assessed by asking caregivers the following questions in the screening survey:
- Are you caring for a family member or friend who is under 18 years of age who has attempted suicide?
- Do you understand that this program is not aimed at family and friends currently experiencing high levels of distress and require more immediate one-on-one support?
- Do you agree to access the online program and complete three short questionnaires?

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)
- 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/09/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 310933 0
Charities/Societies/Foundations
Name [1] 310933 0
Suicide Prevention Australia Innovation Research Grant
Country [1] 310933 0
Australia
Funding source category [2] 310934 0
University
Name [2] 310934 0
University of Newcastle
Country [2] 310934 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] 312228 0
None
Name [1] 312228 0
Address [1] 312228 0
Country [1] 312228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310489 0
University of Newcastle HREC
Ethics committee address [1] 310489 0
Ethics committee country [1] 310489 0
Australia
Date submitted for ethics approval [1] 310489 0
06/09/2021
Approval date [1] 310489 0
03/03/2022
Ethics approval number [1] 310489 0
H-2021-0291

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

Contacts
Principal investigator
Name 117850 0
Dr Sally Fitzpatrick
Address 117850 0
Everymind
James Fletcher Campus
72 Watt Street
Newcastle, NSW 2300
Country 117850 0
Australia
Phone 117850 0
+61249246945
Fax 117850 0
Email 117850 0
sally.fitzpatrick@health.nsw.gov.au
Contact person for public queries
Name 117851 0
Andrew McMahon
Address 117851 0
Everymind
James Fletcher Campus
72 Watt Street
Newcastle, NSW 2300
Country 117851 0
Australia
Phone 117851 0
+61249246900
Fax 117851 0
Email 117851 0
andrew.mcmahon10@uon.edu.au
Contact person for scientific queries
Name 117852 0
Andrew McMahon
Address 117852 0
Everymind
James Fletcher Campus
72 Watt Street
Newcastle, NSW 2300
Country 117852 0
Australia
Phone 117852 0
+61249246900
Fax 117852 0
Email 117852 0
andrew.mcmahon10@uon.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


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.