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In treatment studies of major depressive disorder (MDD), exposure to major life events predicts less symptom improvement and greater likelihood of relapse. In contrast, the impact of minor life events has received less attention. We hypothesized that the impact of minor events on symptom improvement and risk of relapse would be heightened in the presence of concurrent chronic stress. We also hypothesized that major events would predict less symptom improvement and greater risk of relapse independently of chronic stress.Adult patients experiencing an episode of MDD were enrolled into a 16-week trial with antidepressant treatments (n = 156). Forty-three fully remitted patients agreed to participate in a naturalistic 18-month follow-up, and 30 had full data for analyses. Life events and chronic stressors were assessed using a contextual life stress interview.Greater exposure to minor events predicted greater improvement in symptoms during acute treatment, but this relation was specific to those who reported greater severity of chronic stress. During follow-up, however, major life events predicted increased risk of relapse, and this effect was not moderated by chronic stress.High attrition rates led to a small sample size for the follow-up analyses.Exposure to minor events may provide an opportunity to practice problem-solving skills, thereby facilitating symptom improvement. Nevertheless, acute treatment did not protect patients from relapse when they subsequently faced major events during follow-up. Therefore, adjunctive strategies may be needed to enhance outcomes during pharmacotherapy, consolidating benefits from acute treatment and providing skills to prevent relapse.

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. CLINICALTRIAL OSF Registries osf.io/3y54m; https://osf.io/3y54m INTERNATIONAL REGISTERED REPORT PRR1-10.2196/44205