Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001247864
Ethics application status
Approved
Date submitted
28/07/2021
Date registered
15/09/2021
Date last updated
20/05/2024
Date data sharing statement initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of the effect of an m-health app and digital engagement strategy on treatment adherence and suicidal ideation.
Scientific title
A randomised controlled trial of the effect of an m-health app and digital engagement strategy on treatment adherence and suicidal ideation in young adults.
Secondary ID [1] 304900 0
None
Universal Trial Number (UTN)
U1111-1268-2852
Trial acronym
Linked study record
None.

Health condition
Health condition(s) or problem(s) studied:
suicidal ideation 323028 0
Condition category
Condition code
Mental Health 320594 320594 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being trialled in this study is called LifeBuoy. LifeBuoy is a mobile treatment app developed by researchers at the Black Dog Institute. It is a fully automated, self-guided program theoretically grounded in Dialectical Behaviour Therapy (DBT) and Acceptance and Commitment Therapy (ACT). The app was initially developed using co-design approach, with young people with a lived experience of suicide, via online surveys and focus groups. The first version of LifeBuoy was evaluated in a trial (ACTRN12619001671156), which commenced recruitment in March 2020 and completed data collection in September 2020. Preliminary findings demonstrated that it did lead to greater reductions in the severity of suicidal ideation in the intervention group, relative to the control group, at post-intervention – and these gains were maintained at 3-month follow up. The version of Lifebuoy being tested in this current trial has undergone further refinements based on qualitative feedback from trial participants, and in partnership with a youth Lived Experience advisory panel, recruited specifically for this purpose.

The app contains seven learning modules and incorporates wise mind principles (distress tolerance, emotion regulation/mindfulness, interpersonal effectiveness) through interactive learning exercises to help young people develop strategies and problem-solving skills for managing suicide thoughts. Each module (island) is described in more detail below:
Island 1: This module is focused on psychoeducation. It educates the reasons why people have suicidal thoughts. It highlights the association between dissociation and suicide thoughts and harms, and helps users to recognise common signs of dissociation. Finally, it teaches grounding techniques that users can engage in when experiencing suicidal thoughts, distress, or dissociation. The therapeutic goal of this module is to teach self-compassion via education, validation, and normalisation.
Island 2: This module is focused on breathing techniques. It raises awareness of the importance of calm breathing, especially in situations when one is feeling stressed or anxious. It contains breathing tips and interactive practice exercises. The therapeutic goal of this module is relaxation and lowering baseline anxiety via education and interactive practice.
Island 3: This module teaches users a wide range of distress management skills. The therapeutic goal of this module is to learn effective distress management via lowering physiological arousal and practicing soothing activities.
Island 4: This module contains three mindfulness-based exercises aimed at helping users to a) observe physical sensations of an emotion without judgement, b) let-go of thoughts and difficult emotions, and c) anchor into the present moment. Mindfulness practice will help users to disengage or free themselves from automatic and unhelpful ways of thinking more quickly. The therapeutic goal of this module is improved cognitive presence and focus (and less emotional intensity) via mindfulness training.
Island 5: This module educates users about their personal wellbeing contributors vs drains, help simplify and balance their life, and determine where best to focus their energy to prevent worry. The therapeutic goal of this module is holistic; to increase self-care, self-knowledge, and autonomy via reflective activities, self-protective activities, and building a locus of control.
Island 6: This module introduces users to the basics of how emotions work and why they are important. It allows the user to explore emotional responses and learn and cognitive strategies for regulating emotions. The therapeutic goal of this module is improved emotion regulation via education, awareness practice, and cognitive restructuring.
Island 7: This module helps users define what’s important to them, to make considered decisions, and align themselves with what is meaningful to them. It provides practical suggestions on how they may invest effort into the areas of their life that they hope to derive greater satisfaction from. The therapeutic goal of this module is greater self-knowledge and increased agency via meaningful goal setting and decision making.
Safety: The Lifebuoy app also includes certain safety features on the main landing page which users are encouraged to access when in distress. The ‘Help’ button brings up a list of services that users can get in touch with for support, and allows them to create a unique safety-plan for suicidal crisis, which they can share with others (such as their family, doctor, or mental health professional). The ‘Toolbox’ button provides users easy access to some distress management tools, access additional information, and distraction strategies. The app also includes a ‘check-in’ feature that auto-appears when a user accesses the app for the first time each day or is accessible through the home screen. The check-in asks users how they are feeling today and if they select a negative mood, they are directed toward their safety plan, crisis contact numbers, and calming/distracting activities.

Participants will download the LifeBuoy app from the App Store or Google Play onto their personal smartphones. Once the app is downloaded, it will not require internet connection; internet connectivity will only be required to upload usage and adherence data to UNSW servers.

Participants will have access to the app - to complete seven modules - until the end of the 4-month trial period. Each module will take approximately between five to ten minutes to complete. The user will be directed to each module linearly and unlocking a new module will require completion of the previous one (this also is the gamification of the app, as island ‘light up’ or become technicolour when complete). Once modules are unlocked, participants can re-access them at any time.

In addition to the LifeBuoy app, this study is seeking to trial a multicomponent digital engagement strategy aimed at increasing compliance with the LifeBuoy app. The engagement strategy will be comprised of 3 core components:
1. An Instagram account that will deliver brief, visual content that aligns to the strategies and educational information within the app itself.
2. A clinician-written and Lived Experience-written blog that will provide a platform to deliver in-depth therapeutic information and advice for maintaining mental health, and 'real-life' experience of living with mental illness/suicidal thoughts from a Lived Experience perspective, respectively. The amount of content in each blog article will be a 3 to 5-minute read, between 300-600 words.
3. Emails: weekly emails will be sent to participants with links to strategies 1 and 2, to remind them to visit them and in addition, the emails will suggest to participants what module within the app they might like to visit/explore that week and strategies for getting the most out of it. These emails will also include a 2-item survey, asking 1) "Have you visited the Instagram page this week?" (yes/no) and 2) "Have you visited the blog site this week?" (yes/no).

We will track engagement in the strategies (Instagram and Blog articles) by counting the number of ‘followers’ on the Instagram account, and summing the 2-item survey which asks if participants have visited the Instagram and blog page this week. A subset of 40 participants from the LifeBuoy (n=20) and LifeBuoy + Engagement (n=20) arms will be asked to attend semi-structured interviews about their experience with the app and engagement strategies, at the 30-day post baseline time point. Participants will be selected on a first-in first-served basis. Interviews will be conducted separately by two members of the research team via video-conference. There will be a clinical psychologist on standby should the participant require clinical support. Interviews are estimated to take 45 minutes in duration, and will take place within 30-days of the assessment point.

The decision to leverage these specific platforms was derived from a bottom-up approach, where we have spent almost 18 months gathering information and perspectives from young people with a lived experience of suicide. The sources of data include: qualitative interview feedback from participants in the first LifeBuoy trial (HC190764); (ii) data from a broad online survey of 260 mental health app users in Australia (HC200616) (iii) and input from a youth lived experience project advisory group (HC210038). The content and design for the Instagram and blog posts is being developed in consultation with the youth lived experience project advisory group, all of whom were participants in the first LifeBuoy trial.

To deliver on the engagement strategy, Instagram posts will be uploaded at least twice a week throughout the duration of the study, up till 30 days after recruitment of the final study participant. The Instagram account will be public, with comments disabled, as public access allows users to view content anonymously (otherwise they will need to register to view the account, which may be perceived as a barrier to engagement).

For the blog, new articles will be posted once a week throughout the duration of the study, again, up to 30 days following the recruitment of the final participant.
Intervention code [1] 321292 0
Treatment: Other
Comparator / control treatment
The control condition is an attention-matched, app-based placebo control program. This program has been developed to retain the structure and look of the LifeBuoy app (i.e., users will be presented with seven islands), but which will include content that is not based on a manualised therapeutic approach. In each island, users will be provided with written content about topics that peripherally relate to mental health, including stress, confidence, and the importance of goals. For some modules, links to Ted X videos are provided as a different format of information delivery, but no interactive tools or resources are built in, or provided via the app.

The control intervention was designed to provide information for young people that matched the intervention in terms of duration and attention without providing any proven therapeutic content. As with LifeBuoy, each module takes 2 to 7 minutes to complete. Users will not have access to a toolbox function or a mood tracker in the control app.
Control group
Placebo

Outcomes
Primary outcome [1] 328413 0
severity of suicidal ideation, as measured by the Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [1] 328413 0
baseline 0-days, 30-days (primary endpoint), 60-days, and 120-days from participant enrolment.
Primary outcome [2] 328414 0
app engagement, measured by the number of modules / activities / exercises completed, determine by accessing app analytics.
Timepoint [2] 328414 0
baseline 0-days, 30-days (primary endpoint), 60-days, and 120-days from participant enrolment.
Secondary outcome [1] 398940 0
depression severity, as measured by the Patient Health Questionnaire (PHQ9)
Timepoint [1] 398940 0
baseline 0-days, 30-days, 60-days, and 120-days from participant enrolment.
Secondary outcome [2] 398941 0
anxiety severity, as measured by the Generalised Anxiety Disorder assessment (GAD7)
Timepoint [2] 398941 0
baseline 0-days, 30-days, 60-days, and 120-days from participant enrolment.
Secondary outcome [3] 399738 0
social phobia, as measured by the Social Phobia Inventory
Timepoint [3] 399738 0
baseline 0-days, 30-days, 60-days, and 120-days from participant enrolment.
Secondary outcome [4] 399741 0
Drug use, as measured by the Tobacco, Alcohol, Prescription medications, & Other Substance scale
Timepoint [4] 399741 0
baseline 0-days, 30-days, 60-days, and 120-days from participant enrolment.
Secondary outcome [5] 399742 0
impulsivity, as measured by the Barratt Impulsiveness Scale -15
Timepoint [5] 399742 0
baseline 0-days, 30-days, 60-days, and 120-days from participant enrolment.
Secondary outcome [6] 399745 0
Daily stress, as measured by the Brief Daily Stressors Screening Tool
Timepoint [6] 399745 0
baseline 0-days, 30-days, 60-days, and 120-days from participant enrolment.
Secondary outcome [7] 399748 0
Incidents of suicide attempts in the past 30-days, as measured by a survey created for this study.
Timepoint [7] 399748 0
baseline 0-days, 30-days, 60-days, and 120-days from participant enrolment.
Secondary outcome [8] 407732 0
Incidents of non-suicidal self injury in the past 30-days, as measured by a survey created for this study.
Timepoint [8] 407732 0
baseline, 0-days, 30-days, 60-days, 120-days from participant enrolment.

Eligibility
Key inclusion criteria
Study inclusion criteria are as follows:
• 17 - 24 years old.
• Living in Australia.
• Fluent in English.
• Own and have access to a smartphone.
• Experienced suicidal thoughts in the past 30 days.
Minimum age
17 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study exclusion criterion is as follows:
• Have been diagnosed with psychosis or a bipolar disorder in the past 30 days (because of increased risk to this vulnerable group).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed as randomisation of allocation was determined by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The plan is to enrol 669 subjects to this trial. Sample size calculations were based on the primary aims. For Aim 1, to detect an expected minimum effect size of d=0.45 between the LifeBuoy intervention and the control condition on the primary measure of suicidal ideation (SIDAS), determined from the prior LifeBuoy trial (paper in review), with a = 0.01, power = 0.95, and assuming a 0.50 correlation between repeated measures, 112 subjects are needed in each condition. As a three-arm trial, with a 1:1:1 allocation, this means N=336 subjects are required to detect this effect. In addition, assuming an attrition rate of 25% in each group at our 30-day assessment based on the previous trial of LifeBuoy, 450 participants are needed (150 in each arm, rounded up). This sample size is sufficient to detect the expected effects associated with primary aim 1. For Aim 2, our recent systematic review of the engagement literature yielded three studies which were similar in design and population to our study [1-3]. The effect sizes in these studies varied from d = .04 to .53 reflecting a difference in user engagement when comparing a digital intervention only and the same digital intervention with an engagement strategy. Given the small number of studies, there is insufficient information to assume that effect sizes are normally distributed. Thus, the median effect size among the 3 studies (d = .38) was used as a benchmark. To detect an effect size of d=0.38 for primary aim 2 (alpha 0.01, power 0.95, assuming a 0.50 correlation between repeated measures, and 25% attrition), 223 participants are needed in each arm (rounded up). With a 1:1:1 allocation, this means N=669 subjects are required. Therefore, the larger sample size of 669 participants will be chosen to meet requirements of both primary aims.

Qualitative interviews with 40 young people from the LifeBuoy and LifeBuoy + engagement group (minimum of 20 participants from the latter) will be recruited at the 30-day assessment time point, in which they will be asked whether they are interested to take part in an interview about their experience of the app and engagement strategy. This sample size will be large enough to reach saturation of qualitative themes.

Mixed models repeated measures (MMRM) analyses, with maximum likelihood estimation and an appropriate covariance structure, will be used to evaluate longitudinal changes in suicidal ideation and secondary mental health outcomes between the LifeBuoy and attentional control arms. Where required, generalised linear mixed models with an appropriate link function will be used for the analysis of categorial variables. This mixed model approach incorporates all available data, including participants with missing follow-up data points, under the missing-at-random assumption. Analyses will therefore accord with the intention-to-treat principle.

A similar analytical approach will be used to evaluate engagement metrics (i.e., number of modules completed; number and frequency of app logins) and suicidal ideation between the LifeBuoy only and LifeBuoy + engagement strategy arms.

Qualitative feedback on users’ perceived acceptability of the LifeBuoy app and engagement strategy will be examined through semi-structured interviews with a subset of participants (n=40 in total) and questionnaires in the survey. The interview data will be analysed using thematic analysis. An inductive approach, independent of a theoretical confirmative method will be used to identify and group themes. The researchers will then refine the themes and determine the final coding framework. Discrepancies will be resolved by a third researcher to ensure reliability of the process.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2023
Actual
5/06/2023
Date of last participant enrolment
Anticipated
3/07/2023
Actual
30/07/2023
Date of last data collection
Anticipated
27/11/2023
Actual
7/12/2023
Sample size
Target
669
Accrual to date
Final
698
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309273 0
Charities/Societies/Foundations
Name [1] 309273 0
Australian Rotary Health
Country [1] 309273 0
Australia
Funding source category [2] 309279 0
Charities/Societies/Foundations
Name [2] 309279 0
Matana Foundation for Young People
Country [2] 309279 0
Australia
Funding source category [3] 309280 0
Charities/Societies/Foundations
Name [3] 309280 0
Goodman Foundation
Country [3] 309280 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St, Kensington, NSW 2052
Country
Australia
Secondary sponsor category [1] 310244 0
None
Name [1] 310244 0
Address [1] 310244 0
Country [1] 310244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309111 0
UNSW HREC Committee A
Ethics committee address [1] 309111 0
Ethics committee country [1] 309111 0
Australia
Date submitted for ethics approval [1] 309111 0
24/05/2021
Approval date [1] 309111 0
29/07/2021
Ethics approval number [1] 309111 0
HC210400

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

Contacts
Principal investigator
Name 113014 0
Dr Michelle Tye
Address 113014 0
Black Dog Institute, Hospital Road, Randwick, NSW 2031
Country 113014 0
Australia
Phone 113014 0
+61 2 9382 9289
Fax 113014 0
Email 113014 0
[email protected]
Contact person for public queries
Name 113015 0
Michelle Tye
Address 113015 0
Black Dog Institute, Hospital Road, Randwick, NSW 2031
Country 113015 0
Australia
Phone 113015 0
+61 2 9382 9289
Fax 113015 0
Email 113015 0
[email protected]
Contact person for scientific queries
Name 113016 0
Michelle Tye
Address 113016 0
Black Dog Institute, Hospital Road, Randwick, NSW 2031
Country 113016 0
Australia
Phone 113016 0
+61 2 9382 9289
Fax 113016 0
Email 113016 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
Sensitive nature of primary outcome.


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
SourceTitleYear of PublicationDOI
EmbaseThree-arm randomised controlled trial of an m-health app and digital engagement strategy for improving treatment adherence and reducing suicidal ideation in young people: study protocol.2022https://dx.doi.org/10.1136/bmjopen-2021-058584
N.B. These documents automatically identified may not have been verified by the study sponsor.