Using a Safety Planning Mobile App to Address Suicidality in Young People Attending Community Mental Health Services in Ireland: Protocol for a Pilot Randomized Controlled Trial

Abstract

Background Over 700,000 people die by suicide annually, making it the fourth leading cause of death among those aged 15-29 years globally. Safety planning is recommended best practice when individuals at risk of suicide present to health services. A safety plan, developed in collaboration with a health care practitioner, details the steps to be taken in an emotional crisis. SafePlan, a safety planning mobile app, was designed to support young people experiencing suicidal thoughts and behaviors and to record their plan in a way that is accessible immediately and in situ. Objective The aim of this study is to assess the feasibility and acceptability of the SafePlan mobile app for patients experiencing suicidal thoughts and behaviors and their clinicians within Irish community mental health services, examine the feasibility of study procedures for both patients and clinicians, and determine if the SafePlan condition yields superior outcomes when compared with the control condition. Methods A total of 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 or treatment as usual 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 use. The feasibility and acceptability of the following measures in a full randomized controlled trial will also be assessed: the Beck Scale for Suicide Ideation, Columbia Suicide Severity Rating Scale, Coping Self-Efficacy Scale, Interpersonal Needs Questionnaire, and Client Service Receipt Inventory. A repeated measures design with outcome data collected at baseline, post intervention (8 weeks), and at 6-month follow-up will be used to compare changes in suicidal ideation for the intervention condition relative to the waitlist control condition. A cost-outcome description will also be undertaken. Thematic analyses will be used to analyze the qualitative data gathered through semistructured interviews with patients and clinicians. Results As of January 2023, funding and ethics approval have been acquired, and clinician champions across mental health service sites have been established. Data collection is expected to commence by April 2023. The submission of completed manuscript is expected by April 2025. Conclusions The framework for Decision-making after Pilot and feasibility Trials will inform the decision to progress to a full trial. The results will inform patients, researchers, clinicians, and health services of the feasibility and acceptability of the SafePlan app in community mental health services. The findings will have implications for further research and policy regarding the broader integration of safety planning apps. Trial Registration OSF Registries osf.io/3y54m; https://osf.io/3y54m International Registered Report Identifier (IRRID) PRR1-10.2196/44205

Translating Suicide Safety Planning Components Into the Design of mHealth App Features: Systematic Review

“…(2) study methods (eg, aims and research design); (3) study characteristics (eg, sample size, sample demographics, and setting); (4) SPI intervention characteristics (RQ1); (5) mHealth app design features (RQ2) and primary and secondary outcomes (RQ3); and (6) study implications and future directions (Multimedia Appendix 3 [42,43,[53][54][55][56][57][58][59][60][61][62][63][64]). A similar process was used to independently code the SPI components and app features of the mHealth apps available for download.…”

“…The detailed study characteristics of the selected articles (N=14) are presented in Multimedia Appendix 3. Most studies (12/14, 86%) were conducted outside the United States [42,[53][54][55][56][57][58][59][60][61][62][63]. The year range of the selected articles was between 2015 and 2023.…”

“…As such, RCTs with control groups, random assignment, and repeated measure outcomes assessed over time are needed in the future to evaluate the efficacy of using suicide safety planning mHealth apps compared with traditional paper-based safety plans [54,57], specifically related to reducing suicidal urges and behaviors and increasing use of coping strategies, as well as increased engagement in crisis and mental health services after the crisis. When doing so, researchers should recruit larger samples to ensure that the results are conclusive and can be generalized to the populations of interest.…”