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Trial registered on ANZCTR


Registration number
ACTRN12621000712808
Ethics application status
Approved
Date submitted
27/04/2021
Date registered
8/06/2021
Date last updated
10/05/2024
Date data sharing statement initially provided
8/06/2021
Date results provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
BrighterSide: A randomised controlled trial of a self-guided app for suicidal ideation.
Scientific title
A randomised controlled trial of the BrighterSide mobile phone application for adults with suicidal ideation, to compare severity of suicidal ideation post-intervention to a waitlist control group.
Secondary ID [1] 303730 0
None
Universal Trial Number (UTN)
U1111-1266-2757
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 321194 0
Condition category
Condition code
Mental Health 318985 318985 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BrighterSide is a newly developed mobile phone application (app) for adults with suicidal ideation. The app was developed at the Black Dog Institute by mental health clinicians with input from lived experience representatives. The app is designed to help users develop and practice strategies to manage suicidal thoughts, as well as provide relaxation and distraction activities in times of distress. The app contains five modules which contain psychoeducation and associated activities. The modules are: ‘Understand your thoughts’, ‘Prevent a crisis’, ‘Navigate your emotions’, ‘Navigate your thoughts’, and ‘Plan for the future’. The content is based primarily on cognitive behavioural therapy (CBT) and dialectical behaviour therapy (DBT), with elements of acceptance and commitment therapy (ACT) and positive psychology. Each module, assuming a user reads all material and completes all activities, takes between 20 and 50 minutes to complete.

BrighterSide includes a safety plan function where users are encouraged to list their personal warning signs, activities/techniques they find helpful to manage distress, and contact details for support people. The app also includes a ‘check-in’ feature that auto-appears when a user accesses the app for the first time each day. The check-in asks users how they are feeling today, whether they have thoughts of harming themselves, whether they feel able to keep themselves safe, and (if not) provides a link to their safety plan, contact numbers, and calming/distracting activities.

Content is not time-gated and participants in the trial can use the app as often or as little as desired, although app usage data will be collected and will be examined at the conclusion of the trial in secondary analyses.

Participants will be randomly allocated (1:1) to an intervention group, which will have immediate access to the app, and a waitlist control group which will receive access to the app at the conclusion of the trial (12 weeks after enrolment).
Intervention code [1] 320047 0
Behaviour
Intervention code [2] 320673 0
Treatment: Other
Comparator / control treatment
Participants will be randomly allocated (1:1) to an intervention group or a waitlist control group. Participants will not be blinded. Those in the waitlist control group will receive access to the app on completion of the final self-report questionnaires (12 weeks), or at 13 weeks if they do not complete the questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 326909 0
Severity of suicidal ideation as measured by total score on the Suicidal Ideation Attributes Scale (SIDAS).
Timepoint [1] 326909 0
Baseline; 6 weeks (primary timepoint) post-intervention commencement; 12 weeks post-intervention commencement..
Secondary outcome [1] 393072 0
Recent suicide attempts (i.e. within the past 6 weeks) as measured by self-report.
Timepoint [1] 393072 0
Baseline; 6 weeks post-intervention commencement; 12 weeks post-intervention commencement.
Secondary outcome [2] 393073 0
Coping ability as measured by the abbreviated Coping Orientations to Problems Experiences Inventory (Brief-COPE).
Timepoint [2] 393073 0
Baseline; 6 weeks post-intervention commencement; 12 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Individuals are eligible to join the study if they:
• are aged 18 to 65 years;
• reported suicidal ideation within the last 2 weeks;
• own an iPhone or Android smartphone;
• are fluent in English;
• currently live in Australia.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed models repeated measures analyses, with maximum likelihood estimation and an appropriate covariance structure, will be used to evaluate the efficacy of the BrighterSide 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 (baseline to 6 weeks; baseline to 12 weeks). The mixed models approach incorporates all available data, including participants with missing follow-up data points, under the missing-at-random assumption that is robust to data that are missing contingent on observed variables. Analyses will therefore accord with the intention-to-treat principle.

Analyses of secondary outcomes will use the same methods, with linear mixed model repeated measures ANOVA used for continuous outcomes (including SIDAS) and binary mixed models used for binary outcomes such as suicide attempt. If analyses of the SIDAS demonstrate non-normal residuals, alternative distributional assumptions will be tested in sensitivity analyses. The proportion of participants experiencing adverse events in the intervention and control conditions will be compared using a chi-squared test.

A sample size of N=236 is required to allow detection of a small-medium effect size of d=0.3 in severity of suicidal ideation between the intervention and control arms with 80% power and alpha=0.05. This is guided by a pooled effect size of 0.31 from three previous trials that incorporated the intervention content in a web-based program. These three trials have reported an average attrition rate of 35% at post-intervention follow-up, therefore we have conservatively estimated a 40% attrition rate. As such, the recruitment target for the trial is N=394 with an equal allocation of n=197 participants to each arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2021
Actual
30/06/2021
Date of last participant enrolment
Anticipated
31/08/2021
Actual
24/09/2021
Date of last data collection
Anticipated
24/12/2021
Actual
24/12/2021
Sample size
Target
546
Accrual to date
Final
549
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308136 0
Charities/Societies/Foundations
Name [1] 308136 0
Suicide Prevention Australia
Country [1] 308136 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 308916 0
None
Name [1] 308916 0
Address [1] 308916 0
Country [1] 308916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308123 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 308123 0
Ethics committee country [1] 308123 0
Australia
Date submitted for ethics approval [1] 308123 0
22/03/2021
Approval date [1] 308123 0
22/04/2021
Ethics approval number [1] 308123 0

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

Contacts
Principal investigator
Name 109618 0
Dr Mark Larsen
Address 109618 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 109618 0
Australia
Phone 109618 0
+61 2 9065 9145
Fax 109618 0
Email 109618 0
mark.larsen@blackdog.org.au
Contact person for public queries
Name 109619 0
Adam Theobald
Address 109619 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 109619 0
Australia
Phone 109619 0
+61 2 9065 9038
Fax 109619 0
Email 109619 0
a.theobald@blackdog.org.au
Contact person for scientific queries
Name 109620 0
Mark Larsen
Address 109620 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 109620 0
Australia
Phone 109620 0
+61 2 9065 9145
Fax 109620 0
Email 109620 0
mark.larsen@blackdog.org.au

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
No additional documents have been identified.