Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000842864
Ethics application status
Approved
Date submitted
14/05/2021
Date registered
1/07/2021
Date last updated
1/07/2021
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a website to help Australians better manage stress, adapt to change and optimise their mental health
Scientific title
Evaluation of an online, interactive, Acceptance and Commitment Therapy (ACT)-based intervention that aims to help Australian adults better manage stress, adapt to change and optimise their mental health
Secondary ID [1] 303281 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 320475 0
Distress 320476 0
Wellbeing 320477 0
Suicide ideation 320478 0
Condition category
Condition code
Mental Health 318359 318359 0 0
Other mental health disorders
Mental Health 320119 320119 0 0
Anxiety
Mental Health 320120 320120 0 0
Depression
Mental Health 320121 320121 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION NAME

icanactnow website


MATERIALS

The intervention was developed based on ACT by clinical psychologists and with consumer input. All content has been reviewed by additional mental health professionals.

The intervention contains five ACT-based modules that include strategies to foster the key ACT processes of defusion, acceptance, values, connecting with the present moment and psychological flexibility. Users will create a profile (using a pseudonym if preferred) upon first login. The first module begins with a questionnaire to assess current wellbeing and provision of practical psychoeducation. Users are then given carefully tailored feedback and advice, based on their results. Users are given the option of printing the results of their online assessment and a script that will guide a conversation about their mental health with their GP. Users will also be presented with a short video that will show someone else having that conversation with their GP.

The website is free to use, and users are able to log on at any time. Modules have been written for a low reading age, in a friendly way, with appropriate humour. Features include automated text message reminders and messages of support, and a very simple website navigation design suitable for use on desktop, laptops, iPads/tablets and mobile devices. Modules may be completed fortnightly and take 30-40 minutes each to complete. At the end of each module, the program will put together a list of strategies that users can choose to save to their profile or 'tool box'.


PROCEDURES

The website will be open to anyone to use. Alongside the operation of the website, we will conduct a website evaluation using (a) data that is already collected through the website and as part of the intervention, and (b) additional data for those users who wish to help us by answering questionnaires in addition to core measures included in the intervention. The purpose of this is to (1) establish the safety and efficacy of the website (Aim 1), and (2) evaluate the effectiveness of the intervention in targeting each of the key ACT processes (Aim 2).

Data from the first 100 users who register will be used to address Aim 1. This will be the default pathway and all users will be required to allow us to use their data in order to proceed with the website (Option 1). All users will be given the option to answer additional questionnaires. We will use the data of 60 users who opt in to answer additional questionnaires to evaluate the effectiveness of the intervention (Aim 2). These users will answer additional questionnaires upon registration, at the end of the intervention, and 6 months post-intervention (Option 2).

Note: This data will be collected concurrently. Users who opt in to answer additional questionnaires will also complete core measures included in the intervention, and their data will be used to address both aims (Aim 1 and Aim 2). As outlined above, data from the first 100 users who register will be used to address Aim 1, and data from the first 60 users who opt in to answer additional questionnaires will be used to address Aim 2.

All measures will be completed online. The core measures (built into the modules) do not add any time to the intervention for users. Additional optional questionnaires (Option 2) are expected to take 10 minutes at the start of the intervention (before completing Module 1), at the end of the intervention (after completing Module 5), and 6 months post-intervention.

People who are interested in accessing the modules will be required to create an account. Allowing data use for research purposes will be compulsory to enter the website and complete the intervention modules (default pathway; Option 1). Upon creating an account/login, participants will be given the option to answer additional questionnaires (Option 2, as outlined above). Participants who opt in to answer additional research questions (Option 2) will move on to a suite of validated measures (see 'Outcomes' section below) prior to proceeding to the intervention modules. Participants who take the default pathway (Option 1) will proceed to the intervention modules immediately after creating an account/login.


DELIVERY

The intervention is delivered online to individuals. Participants complete five modules approximately fortnightly for 10 weeks, and each module is expected to take approximately 30-40 minutes to complete. Modules will be completed in sequential order; subsequent modules will become available two weeks after completing the preceding module (i.e., Module 2 will be made available two weeks after completing Module 1, and so on). Participants will be sent a text message when each module becomes available, and a week later to remind them to login and complete the module. Five days after completing each module, participants will be sent a text message encouraging them to practice the strategies they have learnt and build them into their life. They can also opt to send themselves additional reminder text messages if they wish.

Participants can access the intervention anywhere with an internet connection (e.g. laptop, desktop, tablet, mobile). Adherence will be assessed with website usage statistics. Participants will be able to revisit the website and return to modules after completion of the intervention period. Participants will also be able to revisit modules they have previously completed within the intervention period.

Individual-tailored content is embedded within the website. Tailored content is delivered throughout the intervention based on participant responses and demographic variables. For example, in doing the baseline assessment, a user may flag that they are having trouble sleeping so they will be provided with a list of practical things to try to improve the quality of their sleep (e.g. sleep hygiene techniques).

In addition, other publicly available information is available on the website.
Intervention code [1] 319583 0
Behaviour
Intervention code [2] 319584 0
Prevention
Intervention code [3] 319585 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326331 0
Change in psychological distress, measured using the Kessler Psychological Distress Scale (K10; Kessler et al., 2003).
Timepoint [1] 326331 0
Baseline: Completed as part of Module 1
Post-intervention: Completed as part of Module 5
Follow-up: Opt-in research questionnaire six months following completion of the content.
Primary outcome [2] 326332 0
Change in global wellbeing, assessed using single-item measure (VanderWeele, Traudel-Fitzgerald, Allin, et al., 2020).
Timepoint [2] 326332 0
Baseline: Completed as part of Module 1
Post-intervention: Complete as part of Module 5
Follow-up: Opt-in research questionnaire six months following completion of the content.
Primary outcome [3] 327483 0
Change in economic impact of wellbeing, assessed using items from the World Health Organization Disability Assessment Schedule (Üstün et al., 2010).
Timepoint [3] 327483 0
Baseline: Baseline: Completed as part of Module 1
Post-intervention: Completed as part of Module 5
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [1] 391071 0
Change in coping strategies, measuring using the Brief COPE (Carver, 1997).
Timepoint [1] 391071 0
Baseline: Completed as part of Module 1
Post-intervention: Opt-in research questionnaire upon completion of the main content.
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [2] 391072 0
Change in strength of automatic thoughts, measured using the Automatic Thoughts Questionnaire-B (ATQ-B; Addis & Jacobson, 1996).
Timepoint [2] 391072 0
Baseline: Completed as part of Module 2
Post-intervention: Opt-in research questionnaire upon completion of the main content.
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [3] 391073 0
Change in positive mental health, measured using Mental Health Continuum-Short Form (Lamers, Westerhof, Bohlmeijer, et al., 2011).
Timepoint [3] 391073 0
Baseline: Opt-in research questionnaire immediately following registration.
Post-intervention: Opt-in research questionnaire upon completion of the main content.
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [4] 391074 0
Change in psychological flexibility, measured using the Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011).
Timepoint [4] 391074 0
Baseline: Opt-in research questionnaire immediately following registration.
Post-intervention: Opt-in research questionnaire upon completion of the main content.
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [5] 391075 0
Change in thought defusion, measured using the Cognitive Fusion Questionnaire (CFQ; Gillanders et al., 2014).
Timepoint [5] 391075 0
Baseline: Opt-in research questionnaire immediately following registration.
Post-intervention: Opt-in research questionnaire upon completion of the main content.
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [6] 395302 0
Change in mindfulness, assessed using Five Facet Mindfulness Questionnaire-Short Form (Bohlmeijer, Klooster & Fledderus, 2011).
Timepoint [6] 395302 0
Baseline: Opt-in research questionnaire immediately following registration.
Post-intervention: Opt-in research questionnaire upon completion of the main content.
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [7] 395308 0
Change in valuing (the consistency with which one lives in accordance with their self-determined values), measured using Valuing Questionnaire (Smout et al., 2014).
Timepoint [7] 395308 0
Baseline: Opt-in research questionnaire immediately following registration.
Post-intervention: Opt-in research questionnaire upon completion of the main content.
Follow-up: Opt-in research questionnaire six months following completion of the content.
Secondary outcome [8] 395311 0
Usability and acceptability of the online intervention, measured using the System Usability Scale (Brooke, 1996).
Timepoint [8] 395311 0
Post-intervention: Completed at end of Module 5.

Eligibility
Key inclusion criteria
The website is open to all adults living in Australia. The additional research component will be open to adults over 18 years of age, who are fluent in English, and who have access to the Internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In our ifarmwell cohort the average change in psychological distress from baseline to post-intervention was 2.97 units. Being a feasibility study we prioritize the reduction in type II errors over type I. Assuming a within individual correlation >0.5, then with N=31 a one sample t-test (1-sided alpha=0.10) has 90% power to detect this change. Assuming a 30% retention rate (based on past studies and our experience with ifarmwell) we plan to use data from 100 users for the analysis of core measures and at least 60 users for the analysis of optional questionnaires.

Note: This data will be collected concurrently. Users who opt in to answer additional questionnaires will also complete core measures included in the intervention, and their data will be used both for analysis of core measures and analysis of optional questionnaires.

Quantitative data will be analysed using STATA or SPSS. Frequencies and descriptive statistics will be used to present the demographic, psychological distress, and coping attributes of the sample and describe their levels of engagement and satisfaction with the program. Within individual change in psychological distress will be assessed using linear mixed models to account for repeated measures. Mixed effects analyses will be employed to assess whether well-being and coping strategies changed over the intervention period and were maintained at follow-up. Regression analyses will examine factors associated with drop out (i.e., demographic variables, level of psychological distress, etc.).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2021
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307693 0
University
Name [1] 307693 0
University of South Australia
Country [1] 307693 0
Australia
Funding source category [2] 307697 0
Charities/Societies/Foundations
Name [2] 307697 0
The Freemasons Foundation Inc.
Country [2] 307697 0
Australia
Funding source category [3] 307698 0
Other Collaborative groups
Name [3] 307698 0
Freemasons Foundation Centre for Male Health and Wellbeing
Country [3] 307698 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
Corner of North Terrace and Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 308391 0
University
Name [1] 308391 0
University of Adelaide
Address [1] 308391 0
North Terrace Campus
North Terrace
Adelaide SA 5000
Country [1] 308391 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307727 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 307727 0
Ethics committee country [1] 307727 0
Australia
Date submitted for ethics approval [1] 307727 0
23/12/2020
Approval date [1] 307727 0
12/01/2021
Ethics approval number [1] 307727 0
Application ID: 203646

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

Contacts
Principal investigator
Name 108294 0
Dr Kate Gunn
Address 108294 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 108294 0
Australia
Phone 108294 0
+61883022137
Fax 108294 0
Email 108294 0
[email protected]
Contact person for public queries
Name 108295 0
Kate Gunn
Address 108295 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 108295 0
Australia
Phone 108295 0
+61883022137
Fax 108295 0
Email 108295 0
[email protected]
Contact person for scientific queries
Name 108296 0
Kate Gunn
Address 108296 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 108296 0
Australia
Phone 108296 0
+61883022137
Fax 108296 0
Email 108296 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
Access to the intervention requires users to create an account using a valid personal email address and phone number. Additionally, for our statistical analyses, we need to be able to link participants' distress and outcome scores over time. To facilitate this, data will be stored such that participants' entries can be linked to multiple entries on the website. It is for this reason that data will be necessarily identifiable. Because data will be identifiable, we will not be making individual participant data for this trial available (as per ethics approval).


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.