Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000422820
Ethics application status
Approved
Date submitted
28/01/2021
Date registered
16/04/2021
Date last updated
16/04/2021
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Applying the Theory of Planned Behaviour to investigate mental health help-seeking among older adults in Australia
Scientific title
Applying the Theory of Planned Behaviour to investigate mental health help-seeking among older adults in Australia: a pilot, feasibility randomised controlled trial
Secondary ID [1] 303284 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health problems 320490 0
Condition category
Condition code
Mental Health 318364 318364 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 318877 318877 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will received a brochure aimed at promoting mental health help-seeking based on the Theory of Planned Behaviour (TPB). The intervention was developed specifically for this study by the primary researcher, who is a registered psychologist, with support from the research team. During the development phase, a consultative group of key stakeholders were interviewed to inform the design, layout and content of the intervention, including primary health care providers, mental health professionals, health care executives, representatives from community organisations, and consumers.

The intervention includes behaviour change messages targeting the three main components of the TPB: attitudes, subjective norms, and perceived behavioural control.
Messages designed to promote favourable attitudes towards help-seeking aim to communicate that help-seeking is a good and useful thing to do. Examples include ‘speaking about your concerns is the best thing to do’, ‘mental health problems can be prevented and treated’, and ‘it will be useful for you and for others if you speak about your concerns’. Messages to promote favourable subjective norms aim to increase perceived social support and reduce mental health-related stigma. Examples include ‘we all have fears and concerns from time to time’, ‘when you experience such concerns you are not alone’, and ‘your doctor expects you to talk about your concerns.’ Messages to promote perceived behavioural control aim to strengthen self-efficacy and reinforce personal choice in help-seeking. Examples include ‘speaking with a doctor about your concerns helps you to take control of your health,’ and ‘it is important to find a doctor who you can trust, and who will work with you to choose the services and treatments that suit your needs’.

The intervention also addresses barriers to help-seeking and includes mental health literacy messages as suggested by previous research and stakeholders. Key barriers to help-seeking identified and addressed include normalisation of the problem, perceived need, and burdening others. Examples of messages targeting perceived barriers include ‘sometimes people don’t want to speak with their doctor, because they think that its normal to get less enjoyment from life as they get older. There is little evidence to suggest this is the case,’ ‘it doesn’t matter how mild or severe your symptoms are’, and ‘you are not burdening others by talking about your mental health’. Mental health literacy information includes details on how and where to seek help, and what treatment options are available. For example, ‘talk to your doctor when you are experiencing symptoms such as headaches and pain, or feel unhappy or down,’ ‘options may include changes to your diet, exercise, day to day activities, medication, or referral to a mental health professional, and ‘the following organisations provide information and support…’.

The brochure will be presented to participants as part of an online survey. Graphic images of each page of the brochure will be presented to participants in the intervention group, and participants will be asked to download a pdf copy of the brochure to read and retain. Participants will be able to read the brochure at their own pace.

Whilst we are not monitoring adherence, time spent reviewing the brochure will be used as a proxy measure.
Intervention code [1] 319587 0
Behaviour
Comparator / control treatment
A comparison group will be included in this study. Participants in the comparison group will receive a brochure developed specifically for this study by the primary researcher with support from the research team. The content of the comparison brochure was informed by interviews with key stakeholders.

The comparison brochure includes the same mental health literacy messages as the intervention brochure and additional general health information based on public health messages. The general health messages include definitions of good health, and physical, social and mental wellbeing, prevalence data on chronic diseases in Australia, national health guidelines on sleep, diet and exercise, and information on where to find reliable sources of health information (e.g., pharmacies, doctors’ surgery, community health centres and government websites). The appearance of the brochure is comparable to that of the intervention brochure to control for design effects.

The brochure will be presented to participants as part of an online survey. Graphic images of each page of the brochure will be presented to participants in the comparison group, and participants will be asked to download a pdf copy of the brochure to read and retain. Participants will be able to read the brochure at their own pace.

Whilst we are not monitoring adherence, time spent reviewing the brochure will be used as a proxy measure
Control group
Active

Outcomes
Primary outcome [1] 326335 0
Feasibility

The feasibility of the intervention will be assessed by asking participants to respond to 10 items measuring different feasibility criterion. Items are rated on 5-point Likert scales from strongly disagree to strongly agree. These self-report items were designed by the research team.

Two open-ended questions will also be included to gain further feedback on the feasibility of the intervention. Participants will be asked to indicate what they liked about the intervention, and how they think the intervention can be improved.
Timepoint [1] 326335 0
Three-weeks post-intervention
Secondary outcome [1] 391080 0
Utility

The utility, defined as the usefulness of the intervention during pandemics/in times of crises, will be measured by asking participants to respond to 6 items, rated on 5-point Likert scales from strongly disagree to strongly agree. These self-report items were designed by the research team specifically for this study.
Timepoint [1] 391080 0
Three weeks post-intervention
Secondary outcome [2] 391081 0
Retention

Retention will be tracked by the researcher, and measured by the number of participants who complete the follow-up questionnaire compared to the number who gave informed consent to participate. Consent is recorded online before commencement of the initial survey.
Timepoint [2] 391081 0
Three weeks post-intervention
Secondary outcome [3] 391082 0
Time spent reviewing the brochure

The time spent viewing the brochure will be recorded in minutes and seconds by the online survey platform.
Timepoint [3] 391082 0
At intervention completion
Secondary outcome [4] 391083 0
Help-seeking intention

Change in participants intention to seek help for mental health concerns will be measured using one item from a Theory of Planned Behaviour (TPB) questionnaire designed by the research team. The item asks participants to rate their intention to speak with a doctor about their mental health on a 7-point Likert scale from strongly disagree to strongly agree.

The TPB questionnaire is a self-report measure designed to assess TPB constructs of attitudes, subjective norms, perceived behavioural control and intentions within the context of mental health help-seeking. The questionnaire was pilot tested by the research team with 54 older adults (aged 65 and older) in Perth, Western Australia. Reliability testing demonstrated acceptable internal consistency of the measure (Cronbach’s alpha .69 to .87).
Timepoint [4] 391083 0
Baseline
Immediately post-intervention
Three weeks post-intervention
Secondary outcome [5] 393103 0
Attitudes towards help-seeking

Change in attitudes towards help-seeking will be measured using one item from the TPB questionnaire. The item asks participants to rate whether speaking with a doctor about their mental health (feeling sad, empty, fearful and/or anxious) would be useless or useful on a Likert scale from 1 -7.
Timepoint [5] 393103 0
Baseline
Immediately post-intervention
Three weeks post-intervention.
Secondary outcome [6] 393104 0
Subjective norms

Change in subjective norms will be measured using one item from the TPB questionnaire. The item asks participants to rate their level of agreement with the statement ‘Society expects me to speak with a doctor about my mental health’ on a 7-point Likert scale from strongly disagree to strongly agree.
Timepoint [6] 393104 0
Baseline
Immediately post-intervention
Three weeks post-intervention.
Secondary outcome [7] 393105 0
Perceived behavioural control

Change in perceived behavioural control will be measured using two items from the TPB questionnaire. One item will assess changes in controllability, which will be measured by asking participants to rate their level of agreement with the statement ‘Taking the required steps to seek mental health support is under my control’ on a 7-point Likert scale from strongly disagree to strongly agree. The second item will assess changes in self-efficacy, which will be measured by asking participants to rate their level of agreement with the statement ‘I am capable of taking the required action(s) to seek mental health support’ on a 7-point Likert scale from strongly disagree to strongly agree.
Timepoint [7] 393105 0
Baseline
Immediately post-intervention
Three weeks post-intervention.
Secondary outcome [8] 393106 0
Help-seeking behaviour

Help-seeking behaviour will be measured by asking participants if they had spoken to a doctor about their mental health, and if they had received treatment from a mental health professional. Participants will be asked to respond to each item with yes/no, and if yes, to specify how long ago they spoke to a doctor or received professional treatment, and the number of times. These self-report items were designed by the research team specifically for this study.
Timepoint [8] 393106 0
Baseline
Three weeks post-intervention

Eligibility
Key inclusion criteria
Adults aged 65 years and older living in metropolitan areas in Australia.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under the age of 65
Living in a rural/remote area
Diagnosis of dementia or Alzheimers disease

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated randomisation by Qualtrics randomisation software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using Qualtrics randomisation software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasibility study therefore no power analyses were conducted. Based on sample size estimates for pilot randomised controlled trials 100 participants are required; 50 participants for each arm. As online surveys have a high drop-out rate we will aim to recruit 200 people.

Intention to treat analysis will be used. As this is primarily a feasibility study, descriptive statistics will be used to report on primary and secondary outcomes.

For the primary feasibility outcome, and secondary outcomes utility, retention, and help-seeking behaviour, descriptive statistics will be calculated as counts and percentages. For all other secondary outcomes, descriptive statistics will be calculated as mean, mode, and standard deviation. Estimated effect sizes and 95% confidence intervals for each outcome will be calculated.

Other inferential analyses will be completed to determine preliminary differences in changes between pre-post measurement scores for the intervention and comparison groups. Unadjusted analyses will be performed. Binary outcomes are help-seeking behaviour. Continuous outcomes are help-seeking intention, attitudes, subjective norms, and perceived behavioural control. Change in the binary outcome will be analysed using chi-squared test, and change in continuous outcomes will be analysed using unpaired t-tests.

Qualitative data will be analysed using thematic analysis in Microsoft excel.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2021
Actual
Date of last participant enrolment
Anticipated
14/05/2021
Actual
Date of last data collection
Anticipated
25/06/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307701 0
University
Name [1] 307701 0
Edith Cowan University
Country [1] 307701 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup
Western Australia 6027
Country
Australia
Secondary sponsor category [1] 308920 0
None
Name [1] 308920 0
Address [1] 308920 0
Country [1] 308920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307730 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 307730 0
Ethics committee country [1] 307730 0
Australia
Date submitted for ethics approval [1] 307730 0
Approval date [1] 307730 0
15/11/2016
Ethics approval number [1] 307730 0
14248

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108306 0
Ms Claire Adams
Address 108306 0
School of Arts and Humanities
JO.30.214
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country 108306 0
Australia
Phone 108306 0
+61 0400 181 583
Fax 108306 0
Email 108306 0
[email protected]
Contact person for public queries
Name 108307 0
Claire Adams
Address 108307 0
School of Arts and Humanities
JO.30.214
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country 108307 0
Australia
Phone 108307 0
+61 0400 181 583
Fax 108307 0
Email 108307 0
[email protected]
Contact person for scientific queries
Name 108308 0
Claire Adams
Address 108308 0
School of Arts and Humanities
JO.30.214
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country 108308 0
Australia
Phone 108308 0
+61 0400 181 583
Fax 108308 0
Email 108308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data not available due to ethical restrictions.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.