RecruitingACTRN12621001257853

Evaluating an online program for carers of people with symptoms of depression or anxiety: a randomised controlled trial


Sponsor

Australian Government Department of Health

Enrollment

216 participants

Start Date

Jul 22, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Caring for a family member or friend who is struggling with depression or anxiety can be incredibly demanding — and carers themselves are at much higher risk of burnout, depression, and isolation. Yet very few programs exist specifically to support people in this role, particularly when the person they care for has not been formally diagnosed. This trial is testing an online program designed specifically for carers of people showing symptoms of depression or anxiety — no formal diagnosis required. Participants are randomly assigned to one of two conditions: the online program alone, or the online program paired with a social forum where carers can connect with others in similar situations. Researchers want to find out which version better helps carers feel less burdened, more confident in their coping, and less socially isolated — and which represents better value for money. You may be eligible if you are 16 or older, currently live in Australia, and are caring for someone whose depression or anxiety symptoms significantly affect their daily life. You must be comfortable using English and have access to a computer. People without internet access or computer access, or who cannot read and write in English, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 anxie

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12621001257853