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Trial registered on ANZCTR


Registration number
ACTRN12621001257853
Ethics application status
Approved
Date submitted
18/07/2021
Date registered
16/09/2021
Date last updated
16/09/2021
Date data sharing statement initially provided
16/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating an online program for carers of people with symptoms of depression or anxiety: a randomised controlled trial
Scientific title
Evaluating an online program for carers of people with symptoms of depression or anxiety: a randomised controlled trial
Secondary ID [1] 304766 0
Nil known
Universal Trial Number (UTN)
U1111-1266-8545
Trial acronym
MTFC trial
Linked study record
This study proceeds a randomised controlled feasibility study: U1111-1266-8325

Health condition
Health condition(s) or problem(s) studied:
Depressive symptomology 322815 0
Anxiety symptomology 322816 0
Carer burden 323254 0
Condition category
Condition code
Mental Health 320405 320405 0 0
Depression
Mental Health 320406 320406 0 0
Anxiety
Mental Health 320826 320826 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is called Minds Together (the program). It is an online support program for community-dwelling people providing informal support to someone living with symptoms of depression or anxiety.
The program aims to support carers in responding to the person living with these symptoms and promoting their own health, well-being and coping. It includes four activity modules: The caring journey, Caring for yourself and others, What matters to you, how to talk about, and Helpful strategies for everyday life. The modules, which are evidence-informed, include targeted psychoeducation, cognitive behavioural therapy (CBT) strategies and tips for self-care and managing stress. They use a mixed-media format, including short videos and infographics that highlight some of the key information and feature 'real life' examples from carers' lived experiences. The modules also include podcasts that feature information and tips from clinicians, academics and experts in the mental health sector. In addition, activities aim to promote carers' mental health.
For example, the timeline activity requires participants to reflect on their caring experience and document how this has changed over time. Participants are encouraged to plot times when they experienced high and low periods over the past few years. Following this activity, carers are presented with a graph of their journey. The visual representation of these experiences aims to show carers that while there are difficult times, there are also good times. At the end of the activity modules, there are take-home messages and resources (e.g. downloadable PDFs) for carers to use at home and in their relationship with the care recipient. Each module takes approximately one hour to complete.
The program has been developed on a web-based platform that has been used in similar online support programs. It is a self-paced program, and participants can revisit modules or activities once they are completed.
Participants will have access to the interventions for ten weeks. The four program modules will be released in a staged approach. In the first week of the study period, participants in both groups will have access to the first module. In the second week, participants will get access to the first and second modules, and so forth for the first four weeks of the study. For the remaining six weeks of the study, participants will have access to all modules. The research team will collect analytics data during this period, i.e. metadata detailing the time spent and pages visited within modules.
Participants in the program + social group will also have access to the social forum for the ten-week period. The social forum is like a Facebook group, except participants can choose a pseudonym, allowing them to remain anonymous (to other participants) when posting or commenting. Unlike Facebook, there is no private messaging feature. As such, all content posted on the forum is visible to all participants in this study condition. The platform is a closed forum that will only contain participants from the study. Participants can contribute to the social forum as much or as little as they like but will be encouraged to log in at least once per week.
The content within the forum will be largely participant-generated. However, the lead researcher will moderate the forum with support from a clinical psychologist. The researcher will post conversation prompts and comment on posts to direct participants to sections of the program or external services if they need more immediate support. The researcher will moderate the forum daily and report any problematic content to their supervisor (a clinical psychologist). If it is deemed necessary, the researcher will remove problematic posts or comments and contact the participant to discuss any concerns. Before accessing the platform, participants need to agree to Terms and Conditions, outlining what is and is not appropriate to post, e.g. content that may incite hatred or be racist, sexist, or discriminatory is deemed inappropriate. During the program access period, the research team will collect analytics data, i.e. metadata detailing the comments, posts and time spent on the social forum.
Intervention code [1] 321146 0
Behaviour
Intervention code [2] 321447 0
Prevention
Comparator / control treatment
Participants in the active control group will only have access to The program, excluding the social forum.
Control group
Active

Outcomes
Primary outcome [1] 328239 0
Change in carers' coping self-efficacy scores using the Coping Self-Efficacy Scale (CSE; Chesney et al., 2006) in pre, post and follow-up surveys for both study groups
Timepoint [1] 328239 0
Participants complete this measure as part of the pre-survey before enrollment. They need to answer all questions in this survey to enrol in the study. The measure will also be in the primary post-survey timepoint (ten weeks after participant enrolment) and the second post-survey timepoint, or follow-up timepoint, (22 weeks following enrollment, or 12 weeks after the program access period).
Primary outcome [2] 328240 0
Change in carer burden scores using the Caregiver Burden Scale (CBS; Zarit et al., 1980) in pre, post and follow-up surveys for both study groups.
Timepoint [2] 328240 0
Participants complete this measure as part of the pre-survey before enrollment. They need to answer all questions in this survey to enrol in the study. The measure will also be in the primary post-survey timepoint (ten weeks after participant enrolment) and the second post-survey timepoint, or follow-up timepoint, (22 weeks following enrollment, or 12 weeks after the program access period).
Primary outcome [3] 328241 0
Change in carers' perceived social support using the brief form of Perceived Social Support Questionnaire (F-SozU K-6; Kliem et al., 2015) in pre, post and follow-up surveys for both study groups.
Timepoint [3] 328241 0
Participants complete this measure as part of the pre-survey before enrollment. They need to answer all questions in this survey to enrol in the study. The measure will also be in the primary post-survey timepoint (ten weeks after participant enrolment) and the second post-survey timepoint, or follow-up timepoint, (22 weeks following enrollment, or 12 weeks after the program access period).
Secondary outcome [1] 398227 0
Change in caring impact on work and activity using the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI: GH) scores in pre, post and follow-up surveys for both study groups.
Timepoint [1] 398227 0
Participants complete this measure as part of the pre-survey before enrollment. They need to answer all questions in this survey to enrol in the study. The measure will also be in the post-survey timepoint (ten weeks after participant enrolment) and the second post-survey timepoint, or follow-up timepoint, (22 weeks following enrollment, or 12 weeks after the program access period).

Eligibility
Key inclusion criteria
-Aged 16 years or over

- Currently living in Australia

- Currently caring for someone with symptoms of depression or anxiety. While the care-recipient does not require a formal diagnosis of depression or anxiety, it is important that symptoms of one or both of these conditions cause the most interference with usual activities such as relationships, work or study. The rationale for this is to ensure we are targeting a cohort of people that can benefit from a program focussed on supporting someone with these symptoms predominantly.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not comfortable reading and writing in English.
- Does not have access to a computer
- Not comfortable using web-based programs.

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 was concealed through the method of simple randomisation using the REDcap web application.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A third party researcher, not privvy to participant data, created an allocation table using simple randomisation. This table was uploaded to REDcap. Researchers the 'randomise' function for each participant which randomly assigned 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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309137 0
University
Name [1] 309137 0
Higher Degree by Research (HDR) scholarship by the University of Newcastle
Address [1] 309137 0
University Dr, Callaghan NSW 2308
Country [1] 309137 0
Australia
Primary sponsor type
Government body
Name
Australian Government Department of Health
Address
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 310145 0
None
Name [1] 310145 0
Address [1] 310145 0
Country [1] 310145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309004 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 309004 0
The University of Newcastle, University Dr, Callaghan NSW, Australia, 2308
Ethics committee country [1] 309004 0
Australia
Date submitted for ethics approval [1] 309004 0
11/02/2021
Approval date [1] 309004 0
17/06/2021
Ethics approval number [1] 309004 0
H-2021-0117

Summary
Brief summary
With a large proportion of people with mental ill-health not engaged with professional services, the role of providing care to these individuals often sits with relatives, friends and social networks. Researchers commonly referred to these individuals as ‘carers’.
The most recent data estimates showed that the number of Australians who identified as informal carers of someone living with a mental health condition was between 225,421 and 1.5 million people (Diminic, Hielscher, Lee, Harris, Schess, Kealton & Whiteford, 2016). Based on these number estimates, carers make a significant contribution to the Australian economy in terms of lowering Government health expenditure. Therefore, keeping carers healthy not only makes humane sense but also good economic sense.
While caring can be very rewarding, carers also experience higher mental ill-health, depression, and anxiety rates than non-carers (Foster 2011; Butterworth et al., 2010; Aggar, 2016). Other risk factors for carers include financial hardship, reduced education and employment opportunities and social isolation (Aggar 2016; Berecki-Gisolf, Lucke, Hockey & Dobson, 2008; Broady & Stone, 2015).
Mental health focussed supports for carers to date typically target carers of people with conditions such as cancer, dementia, and diabetes. While some interventions have been developed for health carers specifically, they usually require the care recipient to have a formal diagnosis of a condition, such as bipolar, schizophrenia and depression. This is despite evidence of challenges associated with symptoms of depression or anxiety that do not meet the threshold for diagnosis.
Recent studies highlight the benefits of online carer interventions and their capacity to improve self-efficacy, self-esteem, and feelings of depression (McKechnie, Barker and Stott, 2014). Results from these studies have also demonstrated the many advantages of online support compared to face-to-face interventions such as ease of accessibility, time convenience, physical convenience and a lack of stigma relating to professional help-seeking (White, 2001). However, a systematic review of the literature did not identify any evidence-based interventions for people supporting someone with symptoms of depression or anxiety.

The following study builds on a previous feasibility study that aimed to explore the feasibility and acceptability of the online program. This two-arm full-scale RCT will assess carers' clinical outcomes in the program condition, compared to the program paired with the social forum condition. Specifically, the study will assess carer burden, coping self-efficacy and social connectedness and compare participants outcomes in each condition, across three time points (baseline, post and 3-month follow-up). The study will also measure the economic value of the program alone compared to the program paired with the social forum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112622 0
Prof Frances Kay-Lambkin
Address 112622 0
University of Newcastle, University Drive, Callaghan NSW 2308 Australia
Country 112622 0
Australia
Phone 112622 0
+61 2 49 216 023
Fax 112622 0
Email 112622 0
frances.kaylambkin@newcastle.edu.au
Contact person for public queries
Name 112623 0
Ms Elloyse Saw
Address 112623 0
Everymind, 72 Watt st, Newcastle, NSW, Australia. 2300
Country 112623 0
Australia
Phone 112623 0
+61401226565
Fax 112623 0
Email 112623 0
elloyse.saw@uon.edu.au
Contact person for scientific queries
Name 112624 0
Ms Elloyse Saw
Address 112624 0
Everymind, 72 Watt st, Newcastle, NSW, Australia. 2300
Country 112624 0
Australia
Phone 112624 0
+61401226565
Fax 112624 0
Email 112624 0
elloyse.saw@uon.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified aggregate data will be shared via academic publications and conference presentations. Data may otherwise be attained by contacting study investigators, particularly for systematic reviews.
When will data be available (start and end dates)?
December 2022 - December 2027
Available to whom?
Researchers
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Data can be obtained by contacting Everymind (everymind@health.nsw.gov.au).
What supporting documents are/will be available?
Ethical approval
Other
'Other' documents specified
Deidentified aggregate data, data dictionary
How or where can supporting documents be obtained?
Type [1] 12925 0
Ethical approval
Citation [1] 12925 0
Link [1] 12925 0
Email [1] 12925 0
Other [1] 12925 0
Data can be obtained by contacting Everymind (everymind@health.nsw.gov.au).
Attachment [1] 12925 0
Type [2] 12926 0
Other
Citation [2] 12926 0
Link [2] 12926 0
Email [2] 12926 0
Other [2] 12926 0
Data can be obtained by contacting Everymind (everymind@health.nsw.gov.au).
Attachment [2] 12926 0
Summary results
No Results