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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 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]

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

Anxiety symptomology

Carer burden

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Studies of normal psychology, cognitive function and behaviour

Mental Health

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]

Behaviour

Intervention code [2]

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]

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]

Eight weeks after participant enrollment.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

25/05/2020

Date of last participant enrolment

Anticipated

Actual

1/07/2020

Date of last data collection

Anticipated

Actual

2/10/2020

Sample size

Target

Accrual to date

Final

108

Recruitment in Australia

Recruitment state(s)

NSW,NT,QLD,SA,TAS,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Higher Degree by Research (HDR) scholarship by the University of Newcastle

Address [1]

University Dr, Callaghan NSW 2308

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee of Hunter New England Local Health District

Ethics committee address [1]

Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton, NSW, 2305, Australia.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/08/2019

Approval date [1]

05/05/2020

Ethics approval number [1]

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

Dr Sally Fitzpatrick

Address

Everymind, 72 Watt St, Newcastle, NSW, Australia, 2300

Country

Australia

Phone

+61 458269035

Fax

[email protected]

Contact person for public queries

Name

Elloyse Saw

Address

Everymind, 72 Watt st, Newcastle, NSW, Australia, 2300.

Country

Australia

Phone

+61 401226565

Fax

[email protected]

Contact person for scientific queries

Name

Elloyse Saw

Address

Everymind, 72 Watt st, Newcastle, NSW, Australia, 2300.

Country

Australia

Phone

+61 401226565

Fax

[email protected]

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 ([email protected]).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12923	Ethical approval			[email protected]	Data can be obtained by contacting Everymind (ever... [More Details]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Fitzgeraldson, E., Triandafilidis, Z., Franklin, Y... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically