ABSTRACT
BACKGROUND: Self-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life. OBJECTIVE: This study describes the protocol for a randomized controlled trial to evaluate the efficacy of the LifeBuoy app for reducing suicidal thoughts and behaviors, depression, anxiety, and psychological distress, and improving general mental well-being in young adults aged 18 to 25 years. METHODS: This is a randomized controlled trial recruiting 378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components). The primary outcome is suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS). The secondary outcomes are suicidal behavior, depression, anxiety, psychological distress, and general mental well-being. The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study. The study also addresses risk factors and responses to the intervention. A series of items assessing COVID-19 experiences is included in the trial to capture the potential impact of the pandemic on this study. Assessments will occur on the following three occasions: baseline, postintervention, and follow-up at 3 months postintervention. A qualitative interview about user experience with the LifeBuoy app will take place within 4 weeks of the final assessment. Using linear mixed models, the primary analysis will compare the changes in suicidal thoughts in the intervention condition relative to the control condition. To minimize risks, participants will receive a call from the team clinical psychologist by clicking a help button in the app or responding to an automated email sent by the system when they are assessed with elevated suicide risks at the baseline, postintervention, and 3-month follow-up surveys. RESULTS: The trial recruitment started in May 2020. Data collection is currently ongoing. CONCLUSIONS: This is the first trial examining the efficacy of a DBT-informed smartphone app delivered to community-living young adults reporting suicidal thoughts. This trial will extend knowledge about the efficacy and acceptability of app-based support for suicidal thoughts in young people. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001671156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378366. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/23655.