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Trial registered on ANZCTR


Registration number
ACTRN12619001671156
Ethics application status
Approved
Date submitted
22/10/2019
Date registered
28/11/2019
Date last updated
29/03/2022
Date data sharing statement initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of a smartphone-based youth suicide prevention application
Scientific title
The LifeBuoy App: A randomised controlled trial of a mHealth intervention to help young people manage suicidal thoughts
Secondary ID [1] 299267 0
None
Universal Trial Number (UTN)
U1111-1240-1272
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 314691 0
Condition category
Condition code
Mental Health 313037 313037 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention condition
The intervention will be provided digitally to individuals through the Lifebuoy app, which is a fully automated, self-help program for young people experiencing mild-to-moderate symptoms of suicidal ideation. The app was developed by researchers at the Black Dog Institute based on the feedback from young people with lived experience of suicidal thoughts and/or suicidal behaviours. Participants will download the 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.
The app contains seven modules derived from Dialectical Behaviour Therapy (DBT) and Acceptance and Commitment Therapy (ACT) and incorporates behavioural activation principles (distress tolerance, emotion regulation/mindfulness, interpersonal effectiveness), followed by an interactive learning exercise to help young people develop strategies and problem-solving skills for managing suicide thoughts. Participants will have 6 weeks to complete the seven modules at their home or locations of their choice and at their own pace, each module will take approximately 3-7 minutes. 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). The information will be provided in text or interactive quizzes. Participants’ level of adherence to the Lifebuoy app will be assessed by the number of modules completed.

Control condition
Participants in the matched attention condition will be given an app that looks the same as LifeBuoy but only contains information about physical health. Please refer to field regarding control treatment for more details.
Intervention code [1] 315724 0
Treatment: Devices
Intervention code [2] 315950 0
Prevention
Comparator / control treatment
This study will utilise a matched attention control group. Participants in the matched attention condition will be given an app which looks the same as LifeBuoy but which only contains information about physical health (e.g., diet, oral care, skin sense). The information will be provided in text or interactive quizzes. The matched attention condition will allow us to test the therapeutic components of the active intervention. Participants will have access to the program for the same duration as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 321589 0
Change in suicidal ideation as measured by the Suicidal Ideation Attributes Scale
Timepoint [1] 321589 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [1] 375498 0
Change in depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 375498 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [2] 375499 0
Change in anxiety symptoms as measured by Generalized Anxiety Disorder-7 (GAD-7)
Timepoint [2] 375499 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [3] 375532 0
Change in psychological distress as measured by The Distress Questionnaire-5 (DQ-5)
Timepoint [3] 375532 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [4] 375533 0
Change in rumination as measured by The Repetitive Thinking Questionnaire-10 (RTQ-10)
Timepoint [4] 375533 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [5] 375534 0
Change in insomnia as measured by The Insomnia Severity Index
Timepoint [5] 375534 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [6] 375535 0
Change in general mental wellbeing as measured by Short Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [6] 375535 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [7] 375536 0
Change in help-seeking intention as measured by The General Help-Seeking Questionnaire
Timepoint [7] 375536 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [8] 375537 0
Change in distress tolerance as measured by Distress Tolerance Scale
Timepoint [8] 375537 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [9] 375538 0
Change in loneliness as measured by Three-Item Loneliness Scale
Timepoint [9] 375538 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [10] 375545 0
Change in actual help-seeking as measured by the modified Client Service Receipt Inventory
Timepoint [10] 375545 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [11] 376127 0
Acceptability of with the app using questions designed specifically for this study
Timepoint [11] 376127 0
Post-intervention
Secondary outcome [12] 376128 0
App usage data, including (1) total time spent on the app, module, and exercise, (2) number of accesses to the app, module, and exercises
Timepoint [12] 376128 0
Assessed continuously from baseline to post-intervention
Secondary outcome [13] 376565 0
Suicide cognition measured by Suicide Cognition Scale
Timepoint [13] 376565 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [14] 376568 0
Suicidal attempts measured by questions: "Have you ever attempted suicide in your life?" and "How long have you been thinking about suicide?" at baseline, and "Have you attempted suicide in the past 30 days?" in other time points.
Timepoint [14] 376568 0
Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
Secondary outcome [15] 376570 0
Acceptability of the LifeBuoy app will be examined through semi-structured interviews with a subset of participants using questions designed specifically for this study.
Timepoint [15] 376570 0
Post-intervention

Eligibility
Key inclusion criteria
Young adults aged between 16 and 25 years with suicidal ideation in the past year, who own and have access to a smartphone, and are living in Australia and fluent in English will be recruited to participate in this study.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young adults who have been diagnosed with psychosis or bipolar disorder or have suicide attempt in the past month will be excluded from the study.

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)
Randomisation to the active or control condition will use an automated web-based platform tailored for this project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to the active or control condition will occur on a 1:1 ratio using a block design (4 participants per block), stratified by gender, age group using an automated web-based platform tailored for this project.
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
Based on a systematic review and meta-analysis, an effect size of 0.30 (Cohen’s d) will be expected between the intervention condition and the control condition at post-test in terms of suicidal ideation as measured by the SIDAS. Based on an attrition rate of 30% and a 0.50 correlation between pre- and post-test SIDAS scores, a sample size of n = 189 in each condition (total N = 378) will detect this expected effect size with power = 0.80 and alpha = 0.05. The planned sample size of n = 189 for the intervention condition will also allow statistical power of at least 0.80 to detect small-to-medium size effects in moderation analyses.

The proposed study will employ mixed models repeated measures analyses, with maximum likelihood estimation and an appropriate covariance structure, to evaluate the efficacy of the Lifebuoy app relative to the control condition. The primary outcome is severity of suicidal ideation as assessed by the Suicidal Ideation Attributes Scale [SIDAS] over time (pre-test to post-test; pre-test to follow-up). The mixed models 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. This same approach will be used to examine reductions in suicidal attempts, depression (PHQ-9) anxiety (GAD-7) psychological distress (DQ-5) rumination (RTQ-10) insomnia (ISI) general mental wellbeing (SWEMWBS), distress tolerance (DTS), loneliness (TILS), suicide cognition (SGS), help-seeking (GHSQ, CSRI) over time. Potential mechanism of the symptom reduction will be measured by the changes in the levels of distress tolerance (DTS), loneliness (TILS) or suicide cognition (SGS). Negative life events (NLESS), grit (SGS) and questions about expectation of treatment success are included in the surveys as potential moderators. Descriptive statistics will be used to evaluate adherence in relation to the LifeBuoy app for participants in the app intervention condition. Adherence will be indicated by total time spent on the app, modules, and exercise, (2) number of accesses to the app, modules, and exercises. Adherence data will be automatically collected via the app. The mixed model approach will be used to determine whether adherence moderates the change in symptom scores over time in the intervention condition. Acceptability of the LifeBuoy app will be examined through semi-structured interviews with a subset of participants and questionnaires in the survey. This interview data will be thematically analysed using a framework analysis approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2020
Actual
11/05/2020
Date of last participant enrolment
Anticipated
31/03/2021
Actual
22/05/2020
Date of last data collection
Anticipated
31/07/2021
Actual
15/10/2020
Sample size
Target
378
Accrual to date
Final
455
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303800 0
Other
Name [1] 303800 0
Social Ventures Australia Diversified Impact Fund
Country [1] 303800 0
Australia
Funding source category [2] 304296 0
Charities/Societies/Foundations
Name [2] 304296 0
Australian Rotary Health
Country [2] 304296 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Kensington, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 304602 0
None
Name [1] 304602 0
NA
Address [1] 304602 0
NA
Country [1] 304602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304319 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 304319 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 304319 0
Australia
Date submitted for ethics approval [1] 304319 0
19/09/2019
Approval date [1] 304319 0
21/01/2020
Ethics approval number [1] 304319 0

Summary
Brief summary
Suicide is the most common cause of death in Australians aged 15 to 44 years, however, only 28% of adolescents and young adults with suicidal thoughts and/or attempts sought help from health professionals. Smartphone app-based psychological treatments for suicidal thoughts have the potential to reduce obstacles in help-seeking by providing accessible, anonymous, and timely support. As such, Black Dog Institute has developed the LifeBuoy app, which was developed based on Dialectical Behaviour Therapy and Acceptance and Commitment Therapy, and was informed by young people with lived experience of suicidal thoughts and/or suicidal behaviours. The aim of this trial was to evaluate whether the app is effective in reducing suicidal ideation, depression and anxiety symptoms among young people. It is hypothesized that participants who used the app will report greater reductions in suicidal ideation, depression, and anxiety symptoms compared to those in control condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96522 0
Dr Michelle Tye
Address 96522 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 96522 0
Australia
Phone 96522 0
+610293829289
Fax 96522 0
Email 96522 0
[email protected]
Contact person for public queries
Name 96523 0
Michelle Tye
Address 96523 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 96523 0
Australia
Phone 96523 0
+610293829289
Fax 96523 0
Email 96523 0
[email protected]
Contact person for scientific queries
Name 96524 0
Jin Han
Address 96524 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 96524 0
Australia
Phone 96524 0
+610293824368
Fax 96524 0
Email 96524 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


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
EmbaseThe effect of a therapeutic smartphone application on suicidal ideation in young adults: Findings from a randomized controlled trial in Australia.2022https://dx.doi.org/10.1371/journal.pmed.1003978
EmbaseThe Effectiveness of a Smartphone Intervention Targeting Suicidal Ideation in Young Adults: Randomized Controlled Trial Examining the Influence of Loneliness.2023https://dx.doi.org/10.2196/44862
N.B. These documents automatically identified may not have been verified by the study sponsor.