JMIR Publications

ABSTRACT

Background:

Each year over 700 000 people die by suicide globally and it was the fourth leading cause of death among 15-29 year olds globally in 2019. Safety Planning is recommended practice when individuals present to health services at risk of suicide. A safety plan, developed in collaboration with a healthcare practitioner, details steps to take in an emotional crisis which includes personal warning signs and internal coping skills, people and places that provide distraction and support, and contact details to use in a crisis. Worldwide, 59% of Health and Fitness App users are aged between 18 and 34 years. SafePlan, a safety planning mobile app, is designed to support young people experiencing suicidal thoughts and behaviours to record the plan developed with their healthcare professional, in a way that is accessible immediately and in-situ.

Objective:

(1) Assess the feasibility and acceptability of using the SafePlan mobile app for patients experiencing suicidal thoughts and behaviours, and their clinicians, within Irish secondary level mental health services, (2) Examine the feasibility of study procedures for both patients and clinicians, (3) Determine if the SafePlan condition yields superior outcomes when compared with the control condition.

Methods:

80 participants aged 16–35 years accessing Irish mental health services will be randomized (1:1) to receive the SafePlan app plus Treatment As Usual (TAU) or TAU plus a paper-based safety plan. The feasibility and acceptability of the SafePlan app and study procedures will be evaluated using both qualitative and quantitative methodologies. The primary outcomes are feasibility outcomes and include the acceptability of the app to participants and clinicians, the feasibility of delivery in this setting, recruitment, retention and app usage. A repeated measures design with outcome data collected at baseline, post-intervention, and 6-month follow-up with an embedded process evaluation will be used.

Results:

Statistical analyses will include description of recruitment rates, participant demographics, details of routine care received, response rates, completion of safety plan (across both conditions), app usage, data from baseline, post and follow-up across measures (BSS, CSSRS, INQ, CSE, CSRI), estimates of the primary outcome event rate and intervention effect size. Thematic analyses will be conducted on data gathered through semi-structured interviews with patients and clinicians.

Conclusions:

The framework for Decision-making after Pilot and feasibility Trials (ADePT) in conjunction with a priori progression criteria will be used to guide the collection and analysis of quantitative and qualitative data, and to inform the decision to progress to a full trial. Clinical Trial: The study has been pre-registered through the Open Science Framework (https://doi.org/10.17605/OSF.IO/3Y54M).