ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Suicide-related coping

Suicidal ideation

Condition category

Condition code

Mental Health

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]

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]

Changes in suicide-related coping as assessed by the Suicide-Related Coping Scale (SRCS; Stanley et al., 2017)

Timepoint [1]

Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)

Secondary outcome [1]

Changes in suicidal ideation as assessed by the Suicidal Ideation Attributions Scale (SIDAS; Van Spijker et al., 2014)

Timepoint [1]

Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)

Secondary outcome [2]

Changes in safety plan use as assessed by examining total number of individual sessions in Beyond Now app analytics

Timepoint [2]

Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)

Secondary outcome [3]

Changes in safety plan use as assessed by examining average individual session length in Beyond Now app analytics

Timepoint [3]

Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)

Secondary outcome [4]

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]

Baseline (T1), one month post-baseline (T2), three months post-baseline (T3)

Secondary outcome [5]

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]

Baseline (T1), weekly for three months post-baseline (T2-T12)

Secondary outcome [6]

Changes in safety plan quality as assessed by Safety Planning Intervention Scoring Algorithm (SPISA; Brown et al., 2020)

Timepoint [6]

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?

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]

Charities/Societies/Foundations

Name [1]

Beyond Blue

Address [1]

Level 5, 278 Flinders Lane, Melbourne, Vic 3000

Country [1]

Australia

Funding source category [2]

University

Name [2]

Deakin University

Address [2]

221 Burwood Hwy, Burwood VIC 3125

Country [2]

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]

University

Name [1]

Deakin University

Address [1]

221 Burwood Hwy, Burwood VIC 3125

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

221 Burwood Hwy, Burwood VIC 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/11/2021

Approval date [1]

21/12/2021

Ethics approval number [1]

2021-399

Summary

Brief summary

This study will examine whether app-based suicide safety planning is effective over a 3-month period in increasing suicide-related coping, reducing suicidal ideation, and supporting the basic psychological needs of self-determination (autonomy, competence, relatedness).

It is hypothesised that (i) overall, participants will experience significant increases in suicide-related coping and self-determination, and significant decreases in suicidal ideation, and (ii) these outcomes will be superior for participants who made a safety plan in collaboration with a clinician, made plans of higher quality, had higher distress tolerance, and had higher autonomous causality orientations.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Glenn Melvin

Address

School of Psychology, Deakin University, Level 5, Deakin University, Building BC, 221 Burwood Hwy, Burwood, VIC 3125

Country

Australia

Phone

+61 3 92445625

Fax

glenn.melvin@deakin.edu.au

Contact person for public queries

Name

Glenn Melvin

Address

School of Psychology, Deakin University, Level 5, Deakin University, Building BC, 221 Burwood Hwy, Burwood, VIC 3125

Country

Australia

Phone

+61 3 92445625

Fax

glenn.melvin@deakin.edu.au

Contact person for scientific queries

Name

Glenn Melvin

Address

School of Psychology, Deakin University, Level 5, Deakin University, Building BC, 221 Burwood Hwy, Burwood, VIC 3125

Country

Australia

Phone

+61 3 92445625

Fax

glenn.melvin@deakin.edu.au

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: glenn.melvin@deakin.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
14165	Informed consent form	glenn.melvin@deakin.edu.au	Available from principal investigator by contactin... [More Details]
14166	Ethical approval	glenn.melvin@deakin.edu.au	Available from principal investigator by contactin... [More Details]
14167	Study protocol	glenn.melvin@deakin.edu.au	Available from principal investigator by contactin... [More Details]

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	Revisiting the factor structure of the suicide-related coping scale: Results from two samples of Australian online help-seekers.	2023	https://dx.doi.org/10.1016/j.psychres.2023.115195

N.B. These documents automatically identified may not have been verified by the study sponsor.

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