Breaking the silence: Randomized controlled trial protocol of a mobile application to reduce suicide stigma, improve literacy, and promote help-seeking.

Authors

Maitena Pierantonelli, Adriana Mira, Tamara Escrivá-Martínez, Rebeca Diego-Pedro, Lorena Desdentado, Rosa M Baños

Published in

Contemporary clinical trials. Pages 108523. Nov 02, 2026. Epub Nov 02, 2026.

Abstract

Suicide is a critical public health concern, with profound individual, familial, and societal consequences worldwide. Suicide stigma constitutes one of the main barriers to help-seeking, promoting silence, discrimination, and social exclusion among those experiencing suicidal thoughts or behaviors. Improving suicide literacy and reducing stigmatization are key prevention targets. However, evidence-based digital interventions specifically targeting suicide stigma remain scarce. To fill this gap, a self-guided mobile application called Breaking the Silence (BreakSi) has been developed. This study describes the protocol of a randomized controlled trial with a crossover design testing the efficacy of BreakSi in reducing suicide stigma, improving suicide literacy, and increasing help-seeking intentions among Spanish-speaking adults from the general population. Two conditions will be compared (immediate-use [iApp] versus delayed-use [dApp]) in a non-clinical adult sample of at least 174 participants, with data collection occurring at five time points (baseline; after the 10-day intervention or waiting period; after the subsequent 10-day period [iApp]; and at one- and three-month follow-ups). Primary outcomes will be assessed using the Stigma of Suicide Scale - Short Form, the Literacy of Suicide Scale, and the General Help-Seeking Questionnaire. Additional measures will include self-stigma, suicidal ideation, depressive and anxiety symptoms, and app usability. BreakSi integrates four evidence-based components (education, indirect contact, cognitive flexibility, and values-based reflection) delivered through interactive cards combining realistic scenarios, self-reflection exercises, and immediate feedback. This trial addresses key limitations of previous digital anti-stigma programs and may contribute to reducing suicide stigma and promoting earlier help-seeking in the general population. Trial registration: ClinicalTrials.govNCT06759129.

PMID:
42971396
Bibliographic data and abstract were imported from PubMed on 03 Nov 2026.

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