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Trial registered on ANZCTR


Registration number
ACTRN12621001256864
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
Date results information initially provided
16/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing online support for informal carers of people living with depressive or anxiety symptomology: a randomised controlled feasibility study
Scientific title
Assessing online support for informal carers of people living with depressive or anxiety symptomology: a randomised controlled feasibility study
Secondary ID [1] 304483 0
Nil known
Universal Trial Number (UTN)
U1111-1266-8325
Trial acronym
Linked study record
This study precedes a full-scale randomised controlled trial with the following UTN: U1111-1266-8545

Health condition
Health condition(s) or problem(s) studied:
Depressive symptomology 322321 0
Anxiety symptomology 322322 0
Carer burden 323251 0
Condition category
Condition code
Mental Health 319992 319992 0 0
Anxiety
Mental Health 319993 319993 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 320821 320821 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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, communication strategies and tips for self-care and managing stress. The modules use a mixed-media format, including short videos, infographics, highlighting 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 mental health. In addition, activities aim to promote mental health for carers.
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 this experience aims to show carers that while there are difficult times, there are also good times.
Similarly, the values activity requires participants to choose their top three values from a list. The list includes broad categories such as ‘the greater good', ‘health’ and ‘security’. As the module progresses, participants are asked to choose which area of life they would like to put this value into practice, e.g. relationships, health, work and play. The activity is intended to support participants to live by their values and give them purpose and direction in their lives. 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. The program has been developed on a web-based platform that has been used in similar online support programs.
The mode of delivery was a self-paced online course. The platform that hosts the program has been used for other online programs. Participants had access to the program for a total of eight weeks. In the first week of the study period, participants in the program group had access to the first module. In the second week, participants had access to the first and second modules, and so forth for the first four weeks of the study. For the remaining four weeks of the study, participants had access to all of the modules. Each module takes approximately one hour to complete. However, participants could continue to access the modules over the eight-week period to revisit activities or download resources once completed. Following this access period and completion of the post-survey, participants from the waitlist group were granted program access. The research team collected analytics data during the program access period, i.e. metadata detailing the time spent and pages clicked within a module.
Intervention code [1] 320841 0
Behaviour
Intervention code [2] 321446 0
Prevention
Comparator / control treatment
Waitlist control. The waitlist control group were put on a wait list for the eight week program access period. Following this period, participants in the wait list condition completed a post-survey and were then granted access to the program.

Control group
Active

Outcomes
Primary outcome [1] 327866 0
Composite outcome: study feasibility, assessed using website metadata, metadata from redCAP survey software, a participant communication log and results from outcome measures.
Researchers assessed the feasibility of the study design using adherence and attrition rates. Program adherence was defined as participants who activated their online program accounts and attrition was defined as those who did not. These data were confirmed using website metadata.

Similarly, survey adherence was defined as completion of the post-survey. This data was confirmed using metadata from survey software, RedCAP.
Researchers also assessed study safety using participant feedback throughout the study and participant depression and anxiety scores across timepoints. These data were confirmed using survey metadata and a participant communication log.

Feasibility of outcome measures was defined as a trend in reduced carer burden, increased coping self-efficacy, anxiety and depressive symptoms across time points. These data were confirmed using survey metadata.
Timepoint [1] 327866 0
Eight weeks after participant enrollment.
Secondary outcome [1] 400870 0
Composite outcome: program acceptability, assessed using post-surveys, semi-structured interviews and website metadata.

Researchers assessed program acceptability using participant responses to program satisfaction questions in surveys and interviews and module completion rates.
For the post-survey, a participant satisfaction measure was developed specifically for this study. Participant satisfaction was defined as most respondents being somewhat or a lot satisfied with all components of the program. These data were confirmed by using survey metadata.
Participant satisfaction was defined by comments about overall program satisfaction in the post-program interviews. This data was confirmed using coded data from software program, Nvivo.

Researchers also assessed participant acceptability using program completion rates. Completion was defined as clicking on every page in at least 50% of the activity modules. This data was confirmed using website metadata.

Timepoint [1] 400870 0
Eight weeks after participant enrolment.

Eligibility
Key inclusion criteria
- Aged 16 years or older
- Currently supporting someone who is experiencing, or has experienced, symptoms of depression or anxiety
- Currently living in Australia
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
-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 privy to participant data, created an allocation table using simple randomisation. This table was uploaded to REDcap. Researchers clicked the 'randomise' button for each participant, 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)
Safety/efficacy
Statistical methods / analysis
To assess program feasibility, program adherence and attrition rates were calculated and participant safety and outcome measures were assessed across the study period. Adherence was defined as participants who activated their online program accounts and attrition was defined as those who did not. An adherence goal of 50% was set as criteria. This was based on literature documenting high attrition rates for online health interventions. Adherence was also assessed through completion rates of surveys at both time points using survey metadata. Researchers assessed study safety by logging participant feedback throughout the study period. Study safety was defined as no feedback from participants regarding their distress from engaging with the study. The study was also considered safe if participant depression or anxiety scores did not increase across timepoints.
The feasibility of outcome measures was assessed using Intention-to-Treat analysis of carer burden and coping self-efficacy scores over time. Intention to Treat analysis of effect over time were performed with linear mixed modelling. Mixed models included mixed effects for timepoint (categorical: Pre, Post), allocation (Waitlist, Program), interaction term of timepoint and allocation, and cohort, and a random effect for participant to account for correlations within participant over time (repeated measures). Assumptions for linear mixed modelling were checked and found to be reasonable. Model estimates are presented as the estimated least squares (LS) means with 95% confidence interval (CI) by timepoint and condition, the overall (interaction) p-value comparing the difference in change over time between the allocations (treatment difference), simple effects for treatment vs control at the Post timepoint and change over time within each allocation (differences with 95% CI and p-values). Plots of the LS-mean estimates (with 95% CI) are provided over time by allocation. Statistical analyses were programmed using SAS v9.4 (SAS Institute, Cary, North Carolina, USA). A priori, p<0.05 (two-tailed) was used to indicate statistical significance


To assess program acceptability, participant satisfaction responses to surveys and interviews and program completion rates were calculated. Program satisfaction in surveys was measured using a study-specific satisfaction measure. Participants rated their satisfaction with program features on a five-point Likert scale (not at all, a little bit, neutral, somewhat, a lot). Program satisfaction was defined as most participants being somewhat or a lot satisfied with program features. Study acceptability was also assessed using post-program interviews. Researchers coded interview responses using Nvivo data analysis software. Researchers cross-checked and discussed results to determine overall program satisfaction domains and summarised the number of participant comments for each program satisfaction domain. Satisfaction was defined as most participants making positive appraisals about the program. Researchers also assessed participant acceptability using program completion rates. Completion was defined as clicking on every page in at least 50% of the activity modules. Researchers logged this data using website metadata.


Recruitment
Recruitment status
Completed
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)
NSW,NT,QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 308913 0
University
Name [1] 308913 0
Higher Degree by Research (HDR) scholarship by the University of Newcastle
Address [1] 308913 0
University Dr, Callaghan NSW 2308
Country [1] 308913 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] 310063 0
None
Name [1] 310063 0
Address [1] 310063 0
Country [1] 310063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308751 0
Hunter New England Human Research Ethics Committee of Hunter New England Local Health District
Ethics committee address [1] 308751 0
Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton, NSW, 2305, Australia.
Ethics committee country [1] 308751 0
Australia
Date submitted for ethics approval [1] 308751 0
29/08/2019
Approval date [1] 308751 0
05/05/2020
Ethics approval number [1] 308751 0
2019/ETH13205

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 explores the feasibility of a Randomised Controlled Trial (RCT) comparing online support for carers of people with depression/anxiety to a waitlist control. The study also explores participant acceptability of the Minds Together program. Feasibility was assessed using adherence and attrition rates. Acceptability was assessed using participant feedback through surveys and interviews. The study also explored the effects of the program on carer burden and coping self-efficacy.





Trial website
Trial related presentations / publications
Public notes
While the study was open to participants Australia, wide, recruitment methods only captured participants from five states and one territory. Participants were predominantly living in New South Wales (78 per cent).

Contacts
Principal investigator
Name 111766 0
Dr Sally Fitzpatrick
Address 111766 0
Everymind, 72 Watt St, Newcastle, NSW, Australia, 2300
Country 111766 0
Australia
Phone 111766 0
+61 458269035
Fax 111766 0
Email 111766 0
sally.fitzpatrick@health.nsw.gov.au
Contact person for public queries
Name 111767 0
Ms Elloyse Saw
Address 111767 0
Everymind, 72 Watt st, Newcastle, NSW, Australia, 2300.
Country 111767 0
Australia
Phone 111767 0
+61 401226565
Fax 111767 0
Email 111767 0
elloyse.saw@uon.edu.au
Contact person for scientific queries
Name 111768 0
Ms Elloyse Saw
Address 111768 0
Everymind, 72 Watt st, Newcastle, NSW, Australia, 2300.
Country 111768 0
Australia
Phone 111768 0
+61 401226565
Fax 111768 0
Email 111768 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 2021 - December 2026
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] 12923 0
Ethical approval
Citation [1] 12923 0
Link [1] 12923 0
Email [1] 12923 0
everymind@health.nsw.gov.au
Other [1] 12923 0
Data can be obtained by contacting Everymind (everymind@health.nsw.gov.au).
Attachment [1] 12923 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Participants were 108 carers, who were randomised to either the program (54 participants) or waitlist (54 participants) condition. The study was feasible and the program was mostly acceptable to participants.
Thirty-two of the 54 participants in the program group activated their program account (adherence equals 59%). Similarly, the retention rate for completion of the pre-and post-surveys was 53%.
No participants contacted the research team to report increased distress because of the study. Furthermore, carers' symptoms of depression and anxiety did not increase over the study period.
At the post-program evaluation, participants in the intervention group reported increased coping self-efficacy and reduced carer burden than those in the waitlist group. These results confirmed the feasibility of the outcome measures.
Responses to the satisfaction measure indicated that 64 – 88% of participants were somewhat or a lot satisfied with the program. Participants identified videos and case-studies and activity handouts as most helpful.
Eight of the ten participants interviewed, commented on the positive impacts of the program overall. Although no negative comments were made about the program, two carers found that it did not add to their existing knowledge base.
Of those who activated their program accounts, 16 participants met the threshold for program completion (completion rate equals 47.5%).