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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
Date results information initially provided
29/03/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
A trial of a smartphone-based youth suicide prevention application
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Scientific title
The LifeBuoy App: A randomised controlled trial of a mHealth intervention to help young people manage suicidal thoughts
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Secondary ID [1]
299267
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None
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Universal Trial Number (UTN)
U1111-1240-1272
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation
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Condition category
Condition code
Mental Health
313037
313037
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0
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Suicide
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
315724
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Treatment: Devices
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Intervention code [2]
315950
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in suicidal ideation as measured by the Suicidal Ideation Attributes Scale
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Assessment method [1]
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Timepoint [1]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [1]
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Change in depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9)
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Assessment method [1]
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Timepoint [1]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [2]
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Change in anxiety symptoms as measured by Generalized Anxiety Disorder-7 (GAD-7)
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Assessment method [2]
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Timepoint [2]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [3]
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Change in psychological distress as measured by The Distress Questionnaire-5 (DQ-5)
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Assessment method [3]
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Timepoint [3]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [4]
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Change in rumination as measured by The Repetitive Thinking Questionnaire-10 (RTQ-10)
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Assessment method [4]
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Timepoint [4]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [5]
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Change in insomnia as measured by The Insomnia Severity Index
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Assessment method [5]
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Timepoint [5]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [6]
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Change in general mental wellbeing as measured by Short Warwick-Edinburgh Mental Wellbeing Scale
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Assessment method [6]
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Timepoint [6]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [7]
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Change in help-seeking intention as measured by The General Help-Seeking Questionnaire
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Assessment method [7]
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Timepoint [7]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [8]
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Change in distress tolerance as measured by Distress Tolerance Scale
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Assessment method [8]
375537
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Timepoint [8]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [9]
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Change in loneliness as measured by Three-Item Loneliness Scale
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Assessment method [9]
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Timepoint [9]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [10]
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Change in actual help-seeking as measured by the modified Client Service Receipt Inventory
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Assessment method [10]
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Timepoint [10]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [11]
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Acceptability of with the app using questions designed specifically for this study
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Assessment method [11]
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Timepoint [11]
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Post-intervention
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Secondary outcome [12]
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App usage data, including (1) total time spent on the app, module, and exercise, (2) number of accesses to the app, module, and exercises
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Assessment method [12]
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Timepoint [12]
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Assessed continuously from baseline to post-intervention
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Secondary outcome [13]
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Suicide cognition measured by Suicide Cognition Scale
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Assessment method [13]
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Timepoint [13]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [14]
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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.
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Assessment method [14]
376568
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Timepoint [14]
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Update: Baseline (day 0), post-intervention (day 42, primary endpoint), and 3-month after intervention completion (day 132 ). This change was prior to recruitment.
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Secondary outcome [15]
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Acceptability of the LifeBuoy app will be examined through semi-structured interviews with a subset of participants using questions designed specifically for this study.
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Assessment method [15]
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Timepoint [15]
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Post-intervention
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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.
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Minimum age
16
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/03/2020
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Actual
11/05/2020
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Date of last participant enrolment
Anticipated
31/03/2021
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Actual
22/05/2020
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Date of last data collection
Anticipated
31/07/2021
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Actual
15/10/2020
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Sample size
Target
378
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Accrual to date
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Final
455
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
303800
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Other
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Name [1]
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Social Ventures Australia Diversified Impact Fund
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Address [1]
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Sydney – Head Office
Level 7, 1 Chifley Square
Sydney NSW 2000
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Country [1]
303800
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Australia
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Funding source category [2]
304296
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Charities/Societies/Foundations
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Name [2]
304296
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Australian Rotary Health
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Address [2]
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2nd Floor, 43 Hunter Street, Parramatta NSW 2150
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Country [2]
304296
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Australia
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Primary sponsor type
University
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Name
University of New South Wales
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Address
Kensington, Sydney NSW 2052
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Country
Australia
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Secondary sponsor category [1]
304602
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None
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Name [1]
304602
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NA
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Address [1]
304602
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NA
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Country [1]
304602
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304319
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UNSW Human Research Ethics Committee
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Ethics committee address [1]
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UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
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Ethics committee country [1]
304319
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Australia
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Date submitted for ethics approval [1]
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19/09/2019
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Approval date [1]
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21/01/2020
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Ethics approval number [1]
304319
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Michelle Tye
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Address
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Black Dog Institute, Hospital Rd, Randwick NSW 2031
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Country
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Australia
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Phone
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+610293829289
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Michelle Tye
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Address
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Black Dog Institute, Hospital Rd, Randwick NSW 2031
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Country
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Australia
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Phone
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+610293829289
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Jin Han
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Address
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Black Dog Institute, Hospital Rd, Randwick NSW 2031
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Country
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Australia
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Phone
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+610293824368
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
The effect of a therapeutic smartphone application on suicidal ideation in young adults: Findings from a randomized controlled trial in Australia.
2022
https://dx.doi.org/10.1371/journal.pmed.1003978
Embase
The Effectiveness of a Smartphone Intervention Targeting Suicidal Ideation in Young Adults: Randomized Controlled Trial Examining the Influence of Loneliness.
2023
https://dx.doi.org/10.2196/44862
N.B. These documents automatically identified may not have been verified by the study sponsor.
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