A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol

Background: Suicidal and non-suicidal self-injurious behaviors are among the leading causes of death and injury in adolescents and youth worldwide. Mobile app development could help people at risk and provide resources to deliver evidence-based interventions. There is no specific application for adolescents and young people available in Spanish. Our group developed CALMA, the first interactive mobile application with the user in Spanish, which provides tools based on Dialectical Behavioral Therapy to manage a crisis of suicidal or non-suicidal self-directed violence with the aim of preventing suicide in adolescents and youth. Methods: To test the effectiveness, safety and level of engagement of the CALMA app in people aged 10 to 19 who are treated in mental health services of two public hospitals, we will conduct a parallel-group, two-arm randomized controlled trial. Participants will be assessed face-to-face and via video call at four timepoints: day-0 (baseline), day-30, day-60, and day-90. A total of 29 participants per group will be included. Change in the frequency of suicidal and non-suicidal self-injurious behaviors will be compared between groups, as well as the level of emotional dysregulation, level of app engagement and time of psychiatric admission during the follow-up period. Discussion: This study is particularly relevant to young people given their widespread use of mobile technology, while there are currently no available smartphone app-based self-guided psychological strategies in Spanish that attempt to reduce suicidal behavior in adolescents who are assisted in the public health sector from low and middle-income countries in Latin America. Clinical trial registration: https://clinicaltrials.gov/, NCT05453370.