Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000186752
Ethics application status
Approved
Date submitted
20/12/2021
Date registered
3/02/2022
Date last updated
28/03/2023
Date data sharing statement initially provided
3/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Beyond Now: Evaluating the effectiveness of a self-guided suicide safety planning app for people at risk of suicide
Scientific title
Beyond Now: Evaluating the use of a self-guided suicide safety planning app and its effect on suicide-related coping, suicidal ideation and self-determination in people at risk of suicide
Secondary ID [1] 305826 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide-related coping 324345 0
Suicidal ideation 324346 0
Condition category
Condition code
Mental Health 321832 321832 0 0
Suicide

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Beyond Now is a publicly-available, free smartphone app available in Australia. It enables people to create a safety plan: a personalised summary of coping strategies and emergency contacts that a person can access during an acute suicidal crisis.

Structured in a stepwise fashion, safety plans support suicidal people to problem-solve their way through a crisis. Based on the Safety Planning Intervention (Stanley & Brown, 2012) and further refined through consultations with users and practitioners, the steps in Beyond Now to be filled out include recognition of warning signs, making the environment safe (means restriction), reasons for living, coping strategies, people and places to connect with to distract from suicidal thoughts, family and friends to contact to disclose suicidal thoughts to and assist during a crisis, and professional and emergency services. Beyond Now users can enter text, photos and videos, and import contacts from their address book to fill out the various steps.

A convenience sample of participants will be recruited from the pool of Beyond Now users who have downloaded and completed a safety plan using the app within the previous 2-4 weeks. These potential participants will be informed about the study via an app notification.

If participants consent to take part, there will be a three-month observation period, with surveys at baseline, one month (T1) and three months (T2); and weekly brief surveys to measure treatment engagement and perceived plan usefulness. All surveys are conducted online through the participant’s mobile device.

The estimated time to complete the surveys is as follows: baseline survey (30 minutes), one month and three-month follow up (15 minutes each), weekly treatment engagement surveys (1 minute each).

Participants are also asked to separately consent to have their app usage and plan content tracked during the three-month observation period.

Data collected in this study will be used to measure:

- Whether there are differences in suicidal ideation and suicide-related coping for users who engage in safety planning on their own, compared to users who engage in planning with a clinician
- Whether any changes in suicidal ideation and suicide-related coping are dependent on how much a person uses their plan, and to what extent the content of their plan is specific and personalised (plan quality)
- Whether plan usage is affected by distress tolerance
- Whether causality orientation affects plan quality, plan use, and differences in suicidal ideation, suicide-related coping outcomes
- Whether plan usage affects changes in feelings of autonomy, competence and relatedness (self-determination needs) among users
Intervention code [1] 322218 0
Early Detection / Screening
Comparator / control treatment
There is no control group for the study, however participants who created safety plans on their own and participants who collaborated on safety plans with a practitioner will be sorted into separate groups during analysis in order to compare their outcomes. Treatment engagement is recorded through the weekly surveys in order to partial out the unique effect of safety plan use on outcomes.
Control group
Active

Outcomes
Primary outcome [1] 329590 0
Changes in suicide-related coping as assessed by the Suicide-Related Coping Scale (SRCS; Stanley et al., 2017)
Timepoint [1] 329590 0
Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)
Secondary outcome [1] 404427 0
Changes in suicidal ideation as assessed by the Suicidal Ideation Attributions Scale (SIDAS; Van Spijker et al., 2014)
Timepoint [1] 404427 0
Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)
Secondary outcome [2] 404428 0
Changes in safety plan use as assessed by examining total number of individual sessions in Beyond Now app analytics
Timepoint [2] 404428 0
Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)
Secondary outcome [3] 404429 0
Changes in safety plan use as assessed by examining average individual session length in Beyond Now app analytics
Timepoint [3] 404429 0
Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)
Secondary outcome [4] 404430 0
Changes in self-determination as assessed by the Autonomy (AU), Environmental Mastery (EM),and Positive Relations With Others (PR) three sub-scales from the Scales of Psychological Wellbeing (SPWB; Ryff, 1989).
Timepoint [4] 404430 0
Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)
Secondary outcome [5] 404431 0
Changes in perceived plan usefulness usage as assessed by a survey question asking participants to rate perceived usefulness of plan on a 4-point Likert scale
Timepoint [5] 404431 0
Baseline (T1), weekly for three months post-baseline (T2-T12)
Secondary outcome [6] 404432 0
Changes in safety plan quality as assessed by Safety Planning Intervention Scoring Algorithm (SPISA; Brown et al., 2020)
Timepoint [6] 404432 0
Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)

Eligibility
Key inclusion criteria
To be eligible to take part in this study, participants will need to be:
- 18 years or over
- A current user of the Beyond Now app who has completed a new safety plan for personal use no more than 4 weeks prior to participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A series of power and sample size calculations were performed using G*Power Version 3.1.9.4 (Faul, 2007). These calculations incorporated the various statistical tests that will be required to answer the research questions. It is estimated that a minimum of 168 participants with a full set of responses will be required. Our target number for recruitment will be larger to account for attrition across the study.

For each participant who has consented, we will have data collected from surveys (baseline, weekly, 1 month, 3 months), their plan usage and plan content over 3 months. Individual safety plans (including any updated versions made during the participation period) will be assigned a score using the Safety Planning Intervention Scoring Algorithm (SPISA; Brown et al., 2020).

Random effects regression models will be used to predict changes in suicide-related coping and suicidal ideation over time, controlling for plan quality, collaboration and perceived usefulness.

Random effects regression models will be used to predict aspects of safety plan use (number of times the plan was accessed, average time spent accessing the plan) while controlling for distress tolerance, plan quality and perceived usefulness.

A two-way mixed ANCOVA will examine whether plan usage differs by causality orientation over time, controlling for plan quality.

Multi-level modelling will be used to determine whether autonomy, competence and relatedness predicts changes in suicidal ideation and suicide-related coping across time (level 1 relationships), and whether there are differences in these outcomes for participants by causality orientation (level 2 relationships).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2022
Actual
28/03/2022
Date of last participant enrolment
Anticipated
1/10/2022
Actual
2/11/2022
Date of last data collection
Anticipated
2/02/2023
Actual
2/02/2023
Sample size
Target
1000
Accrual to date
Final
978
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310175 0
Charities/Societies/Foundations
Name [1] 310175 0
Beyond Blue
Country [1] 310175 0
Australia
Funding source category [2] 310177 0
University
Name [2] 310177 0
Deakin University
Country [2] 310177 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Beyond Blue
Address
Level 5, 278 Flinders Lane, Melbourne, Vic 3000
Country
Australia
Secondary sponsor category [1] 311261 0
University
Name [1] 311261 0
Deakin University
Address [1] 311261 0
221 Burwood Hwy, Burwood VIC 3125
Country [1] 311261 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309862 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309862 0
Ethics committee country [1] 309862 0
Australia
Date submitted for ethics approval [1] 309862 0
17/11/2021
Approval date [1] 309862 0
21/12/2021
Ethics approval number [1] 309862 0
2021-399

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

Contacts
Principal investigator
Name 115646 0
A/Prof Glenn Melvin
Address 115646 0
School of Psychology, Deakin University, Level 5, Deakin University, Building BC, 221 Burwood Hwy, Burwood, VIC 3125
Country 115646 0
Australia
Phone 115646 0
+61 3 92445625
Fax 115646 0
Email 115646 0
[email protected]
Contact person for public queries
Name 115647 0
Glenn Melvin
Address 115647 0
School of Psychology, Deakin University, Level 5, Deakin University, Building BC, 221 Burwood Hwy, Burwood, VIC 3125
Country 115647 0
Australia
Phone 115647 0
+61 3 92445625
Fax 115647 0
Email 115647 0
[email protected]
Contact person for scientific queries
Name 115648 0
Glenn Melvin
Address 115648 0
School of Psychology, Deakin University, Level 5, Deakin University, Building BC, 221 Burwood Hwy, Burwood, VIC 3125
Country 115648 0
Australia
Phone 115648 0
+61 3 92445625
Fax 115648 0
Email 115648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case by case basis at the discretion of the principal investigator, based on a methodologically sound proposal and relevant ethics approval being received
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access will be subject to approvals by principal investigator via contacting:
A/Prof Glenn Melvin
School of Psychology, Faculty of Health
Deakin University
Building BC, 221 Burwood Hwy
Burwood, Victoria 3125
Australia
Email: [email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRevisiting the factor structure of the suicide-related coping scale: Results from two samples of Australian online help-seekers.2023https://dx.doi.org/10.1016/j.psychres.2023.115195
N.B. These documents automatically identified may not have been verified by the study sponsor.