Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000201673
Ethics application status
Approved
Date submitted
7/02/2023
Date registered
24/02/2023
Date last updated
24/02/2023
Date data sharing statement initially provided
24/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A mixed-methods evaluation of a digital, self-guided mental health program with the LGBTQIA+ community
Scientific title
Examining the impact of a digital, self-guided, Acceptance and Commitment Therapy based mental health promotion program on mental health and wellbeing outcomes with the LGBTQIA+ community
Secondary ID [1] 308691 0
Nil known
Universal Trial Number (UTN)
Trial acronym
YOLO LGBTQIA+
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 328621 0
Wellbeing 329035 0
Condition category
Condition code
Mental Health 325624 325624 0 0
Anxiety
Mental Health 325625 325625 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will involve the evaluation of the YOLO (You Only Live Once) (Viskovich & Pakenham, 2020) mental health promotion program with members of the LGBTQIA+ community through a randomized control trial (RCT). Members of the community will be recruited through a variety of active channels, including partner community organisations such as Open Doors Youth Services, online social media channels, and snowballing.

The intervention used in this study is the You Only Live Once (YOLO) program previously validated with a sample of university students (Viskovich and Pakenham, 2020). The program is not designed to treat mental illness but teach skills to promote mental health.

This online self-guided mental health program is underpinned by Acceptance and Commitment Therapy (ACT). It contains four modules that cover all six core ACT processes and are each approximately half an hour long, and modules are designed to be completed sequentially. Participants will be recommended that they complete one module per week over four weeks, but will be able to complete them at a pace that suits them (for example, all in one session). The modules include include:

Module 1: Values and committed action
Module 2: Cognitive defusion
Module 3: Acceptance
Module 4: Mindfulness and the observer self

Intervention content includes animated presentations, videos, audio files, and written exercises. The program is completely self-guided and involves no researcher or clinician involvement.

Participants will complete baseline, immediate-post, and 12-week follow up assessments. These will cover a wide range of psychological constructs such as mental health, life satisfaction, ACT processes such as acceptance, and LGBTQIA+ minority stress. Participants will also be able to provide feedback as they complete each module on what they liked and didn’t like about the program. This will be through a survey embedded within the program which will appear at the end of the module. Automated SMS and email reminders will be sent to participants during the program to encourage module and assessment completion.

Tailoring programs to the LGBTQIA+ community are an important component of online mental health interventions for this group. Therefore, as the program was initially designed to promote wellbeing for university students, the content will be re-shaped to remove reference and applicability to students. Process tailoring will be conducted by choosing affirming LGBTQIA+ imagery and promoting it as a preliminary evaluation of a program specifically for this community. Content tailoring will ensure that the programs content is general in nature for safety, but the existing content will not be shaped around common LGBTQIA+ experiences (e.g., “coming out”). This to firstly determine the impact of more generic therapeutic content, and secondly to serve as a blank canvas to inform future changes to the program following this RCT.

When participants sign up for the program, they will be offered the opportunity to complete interviews with members of the research team about their experiences and identified areas for future improvements to the program. Participants will also be invited to provide feedback on each module following completion to identify in-the-moment user-identified changes.

The original trials of YOLO were not pre-registered. For more information about the program, please consult the reference below.

Viskovich, S, Pakenham, KI. Randomized controlled trial of a web-based Acceptance and Commitment Therapy (ACT) Program to promote mental health in university students. J. Clin. Psychol. 2020; 76: 929– 951. https://doi.org/10.1002/jclp.22848
Intervention code [1] 325155 0
Behaviour
Comparator / control treatment
The study will have an intervention condition and a wait-list control. Participants will be randomly assigned to one of the two conditions in the RCT (i.e., all participants will have equal chance at being allocated to either the intervention or waitlist control). Those in the intervention condition can commence immediately, and those in the control will be asked to wait four weeks (and repeat baseline measurement for comparison) before commencing. Participants in the waitlist condition will be allowed to continue accessing their usual care and support during this time.
Control group
Active

Outcomes
Primary outcome [1] 333470 0
Changes in depressive symptoms as measured by the Depression, Anxiety, Stress Scale 21 item version (Lovibond & Lovibond, 1995).
Timepoint [1] 333470 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement, primary timepoint)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Primary outcome [2] 333471 0
Participant feedback on potential changes to the YOLO program measured as one composite primary outcomes.

Three strands of data collection will be triangulated to inform this outcome. This will include:
1) Responses to open-text module specific feedback. This will be an open-text survey embedded into the module and will appear once the module is completed.
2) Responses to the System Usability Scale (SUS; Brooke 1986)
3) Post-program interviews. These will be semi-structured interviews with participants who will be contacted after the four week intervention window (i.e., four weeks after being granted access to the program). Interviews will be conducted with members of the research team online or face-to-face where available. Interview topics will explore perceptions of the program, and participants will not be required to have completed every module to participate, given the value in exploring why someone did not want to continue with the program. As a thank you, participants will receive a $50.00 gift-card.

Data will be analysed using content analysis (Erlingsson & Brysiewicz, 2017), thematic analysis (Braun and Clarke, 2013) and descriptive analyses.

Data will be triangulated to inform overall user experience into one composite primary outcome. For example, when reporting this outcome, equal weighting will be placed on system usability as measured quantitatively, and thematic / content analysis of feedback provided through open-text surveys and interviews.

Braun, V., & Clarke, V. (2013). Successful qualitative research: A practical guide for beginners Sage.

Erlingsson, C., & Brysiewicz, P. (2017). A hands-on guide to doing content analysis. African Journal of Emergency Medicine, 7(3), 93-99. https://doi.org/https://doi.org/10.1016/j.afjem.2017.08.001

Sauro, J. (2011). Measuring Usability with the System Usability Scale (SUS). Retrieved from https://measuringu.com/sus/d
Timepoint [2] 333471 0
The strands of data for this primary outcome will be collected at three different points. Open-text feedback will be collected as participants complete the program (between the baseline assessment and post-intervention assessment). Participants will complete the SUS as part of the post-intervention assessment. Finally, participants will complete interviews a minimum of four weeks after being granted access to the program to allow participants to complete it within the recommended timeframe. Once all strands are collected, this information will be triangulated to inform feedback on the program.
Primary outcome [3] 333871 0
Changes in mental wellbeing as measured by the Mental Health Continuum Short Form (Keyes, 2009).
Timepoint [3] 333871 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement, primary timepoint)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [1] 417192 0
Changes in Acceptance as measured by the Acceptance and Action Questionnaire 2 (Bond et al. 2011).
Timepoint [1] 417192 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [2] 418272 0
The number of YOLO modules completed. Participant's individual progress through modules is automatically recorded and is accessible to provide an objective measurement of progress.
Timepoint [2] 418272 0
This will be evaluated as participants complete their post-intervention assessment (a minimum of four weeks after completing baseline measurement).
Secondary outcome [3] 418273 0
LGBTQIA+ minority stress assessed using the LGBTQIA+ Minority Stress Measure (Outland, 2016).


Outland, Pearl L.(2016). Developing the LGBT minority stress measure. Colorado State UniversityProQuest Dissertations Publishing,2016.10149909.
Timepoint [3] 418273 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [4] 418586 0
Changes in Cognitive Fusion as measured by the Cognitive Fusion Questionnaire (Gillanders et al. 2014)
Timepoint [4] 418586 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [5] 418587 0
Changes in values based living as measured by the Engaged Living Scale (Trompetter et al. 2013).
Timepoint [5] 418587 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [6] 418588 0
Changes in present-moment awareness as measured by the Mindful Attention Awareness Scale (Brown & Ryan, 2003)
Timepoint [6] 418588 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [7] 418589 0
Changes in self-compassion over time as measured by the Self-Compassion Scale Short Form (Raes et al. 2011).

This is an additional primary outcome.
Timepoint [7] 418589 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement, primary timepoint)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [8] 418590 0
Changes in satisfaction with Life over time as measured by the Satisfaction with Life Scale (Diener et al. 1985).

This is considered an additional primary outcome.
Timepoint [8] 418590 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement, primary timepoint)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [9] 418764 0
Changes in anxiety symptoms as measured by the Depression, Anxiety, Stress Scale 21 item version (Lovibond & Lovibond, 1995).

This is considered an additional primary outcome.
Timepoint [9] 418764 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement, primary timepoint)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)
Secondary outcome [10] 418765 0
Changes in stress symptoms as measured by the Depression, Anxiety, Stress Scale 21 item version (Lovibond & Lovibond, 1995).

This is considered an additional primary outcome.
Timepoint [10] 418765 0
Time point 1: Baseline assessment (immediately prior to randomisation to treatment or waitlist control condition
Time point 2: Post-intervention assessment (four weeks after completing baseline measurement, primary timepoint)
Time point 3: Post-intervention assessment follow up - intervention arm only (16 weeks after completing baseline measurement)

Eligibility
Key inclusion criteria
1) Living in Australia
2) A member of the LGBTQIA+ community
3) English language proficiency
4) Aged 16 and above

Given poorer mental health often reported in the LGBTIQA+ community, participants will be allowed to continue any other psychological support as required outside of the program. Participants will also be eligible to participate if they currently experience severe mental illness.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Allocation to treatment or waitlist control will not be performed by researchers. A code embedded within the Qualtrics software will perform this randomisation and allocation automatically.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is designed to have approximately 80% power to detect a treatment effect size of 0.66 standard deviations between groups (n = 142). Power effects calculated using ClinCalc (ClinCalc, 2019) and data from a previous YOLO RCT (Viskovich & Pakenham, 2020).

Following the analysis plan described by Viskovich and Pakenham (Viskovich & Pakenham, 2020), repeated measures ANOVAs will be used to determine significant changes across outcome measures at baseline , post, and 12-week follow-up to ascertain whether intervention use would be associated with changes in primary and secondary outcomes between time points. Mediation analyses will be conducted to understand if core ACT processes act as a mechanism of change and mediate outcomes (e.g., does psychological flexibility mediate changes in mental health and distress over time?). To explore participant engagement and the unique role of ACT components, investigations into participant responses to exercises will be explored following similar approaches conducted by the current investigators (Viskovich et al., 2021). This involve thematically analysing responses to interventions to understand to, for example, determine what is highly valued among LGBTQIA+ individuals and how many participants completed this specific exercise. Mediation analyses will also be conducted to determine if changes in ACT processes attenuate the relationship between LGBTQIA+ minority stress and mental health outcomes. Repeated measures ANCOVAs will be used to identify whether the number of modules completed impact mental health outcomes.

RCT open-text feedback will be analysed using thematic analysis (Braun & Clarke, 2013) and content analysis (Erlingsson & Brysiewicz, 2017). Post-program interviews will be analysed using thematic analysis (Braun & Clarke, 2013). This qualitative analysis will be conducted collaboratively with members of the research team, some of whom have lived experience as a member of the LGBTQIA+ community. SUS scores will be analysed descriptively through inspection of means and frequencies of usability. Post-program interviews will be analysed using thematic analysis (Braun & Clarke, 2013).

Once all data has been independently analysed, data will be triangulated with equal weighting of both quantitative and qualitative data sources to inform the overall efficacy of the program and considerations for future changes.

ClinCalc. (2019). Sample Size Calculator. Retrieved 11/02/2022 from https://clincalc.com/stats/samplesize.aspx

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
20/02/2024
Actual
Sample size
Target
284
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313210 0
University
Name [1] 313210 0
The University of Queensland
Country [1] 313210 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland, Faculty of Medicine, School of Public Health, 288 Herston Road, Brisbane, Queensland, 4006.
Country
Australia
Secondary sponsor category [1] 314598 0
None
Name [1] 314598 0
Address [1] 314598 0
Country [1] 314598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312193 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 312193 0
Cumbrae-Stewart building (72)
The University of Queensland
Brisbane QLD 4072 Australia
Ethics committee country [1] 312193 0
Australia
Date submitted for ethics approval [1] 312193 0
21/11/2022
Approval date [1] 312193 0
14/02/2023
Ethics approval number [1] 312193 0
2022/HE002167

Summary
Brief summary
Members of the LGBTQIA+ (lesbian, gay, bisexuals, transgender, queer, intersexual, asexual, plus other gender, sexual, or romantic minority identities) are at higher risk of poor mental health. One therapeutic approach that has been shown to improve mental health for this community is Acceptance and Commitment Therapy (ACT). In addition, digital programs that promote mental health have been shown to be effective and acceptable in this community.

This project aims to conduct the first randomised control trial (RCT) evaluating a digital mental health promotion program underpinned by ACT with the LGBTQIA+ community. The intervention used in this program is called YOLO (You Only Live Once), which has demonstrated efficacy in improving mental health with university students. Findings from this RCT will inform changes necessary to the YOLO program to co-design a world-first digital ACT program for LGBTQIA+ people.

This trial will involve three distinct phases. Phase 1 involves the quantitative evaluation of efficacy based on self-report data on measures of mental health and ACT processes. This will determine the efficacy of the program to improve mental health. Phase 2 involves the qualitative analysis of feedback provided during YOLO modules. Phase 3 involves interviews with participants about their experiences with the YOLO program and desired changes. Both phases 2 and 3 will inform changes to the YOLO program to make it more LGBTQIA+ affirming in future projects.

This research is guided by six research questions:

Question 1: Will the YOLO program be associated with improved mental health for members of the LGBTQIA+ community compared to a waitlist control?

Question 2: What changes will participants recommend to improve the usability of the program and make it LGBTQIA+ affirming?

Question 3: Will the YOLO program improve ACT processes for members of the LGBTQIA+ community compared to a waitlist control?

Question 4: Will ACT processes mediate the mental health changes that occur during the RCT?

Question 5: Does completion rate influence the mental health outcomes experienced during the RCT?

Question 6: Do changes in ACT processes mediate the relationship between LGBTQIA+ minority stress and mental health outcomes?

In brief, we hypothesise that completing the program will improve the mental health of participants. We anticipate high usability, but a myriad of changes recommended to make the program more affirming. We further predict that ACT processes will improve throughout the trial and that these changes will influence the mental health outcomes gained. As well, we predict that completion amount of the program will influence the mental health outcomes and changes in ACT processes reported, in that those who complete all modules will report higher mental health and ACT process changes. We finally predict that the relationship between LGBTQIA+ minority stress and mental health will be influenced by ACT processes.
Trial website
https://yolo.psy.uq.edu.au/lgbtqiaplus/
Trial related presentations / publications
Public notes
ACT as a therapeutic framework has over 1000 RCTs in a broad range of populations and conditions. There is also some efficacy in supporting the mental health of LGBTQIA+ individuals (Fowler et al. 2022), however no RCTs have ever been conducted focusing on this population. As well, none have ever used a digital and/or a self-guided format.

Fowler, J.A., Viskovich, S., Buckley, L., & Dean, J.A. (2022).A call for ACTion: a systematic review of empirical evidence for the use of Acceptance and Commitment Therapy (ACT) with LGBTQI+ individuals. Journal of Contextual Behavioral Science, 25, 78-89. doi: 10.1016/j.jcbs.2022.06.007

James Fowler receives a Research Training Program (RTP) Living Stipend to complete this study within their doctoral studies. Dr Judith Dean, Dr Lisa Buckley, and Dr Shelley Viskovich provide in-kind supervision to James Fowler and project oversight as part of Mr Fowler's doctoral studies.

Contacts
Principal investigator
Name 123802 0
A/Prof Judith Dean
Address 123802 0
UQ Poche Centre for Indigenous Health
The University of Queensland
74 High St, Toowong, Brisbane, QLD 4066
Country 123802 0
Australia
Phone 123802 0
+61 417768940
Fax 123802 0
Email 123802 0
j.dean4@uq.edu.au
Contact person for public queries
Name 123803 0
A/Prof Judith Dean
Address 123803 0
UQ Poche Centre for Indigenous Health
The University of Queensland
74 High St, Toowong, Brisbane, QLD 4066
Country 123803 0
Australia
Phone 123803 0
+61 417768940
Fax 123803 0
Email 123803 0
j.dean4@uq.edu.au
Contact person for scientific queries
Name 123804 0
A/Prof Judith Dean
Address 123804 0
UQ Poche Centre for Indigenous Health
The University of Queensland
74 High St, Toowong, Brisbane, QLD 4066
Country 123804 0
Australia
Phone 123804 0
+61 417768940
Fax 123804 0
Email 123804 0
j.dean4@uq.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?
Responses to psychological surveys.

When participants consent to join the RCT they have the additional opportunity to consent to have their anonymous, de-identified data shared. Only the data of those who consent to this will be made available.
When will data be available (start and end dates)?
Data will be available from approximately 1st January 2025 and will be available for seven years, following which it will be archived.
Available to whom?
Data will only be made available on a case-by-case request at the discretion of the Primary Investigator due to the confidential and sensitive nature of the data.
Available for what types of analyses?
There are currently no stipulations as to what type of analyses can be conducted. The purpose of the analysis as described by interested parties will help inform case-by-case approval.
How or where can data be obtained?
Access subject to approvals by the Primary Investigator Dr Judith Dean (j.dean4@uq.edu.au).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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