ANZCTR - Registration

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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]

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

Suicide Attempt

Condition category

Condition code

Mental Health

Suicide

Mental Health

Anxiety

Mental Health

Depression

Mental Health

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]

Behaviour

Intervention code [2]

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]

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]

Baseline, Eight (8) weeks after randomisation.

Primary outcome [2]

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]

8 weeks post-randomisation, 3 months post-intervention completion.

Secondary outcome [1]

Caregiver strain measured using the Zarit Burden Interview (ZBI).

Timepoint [1]