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.

CALMA, a Mobile Health Application, as an Accessory to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injured Behaviors: A Pilot Cluster Randomized Controlled Trial.

The present study was aim to evaluate the acceptability and preliminary effectiveness of a mobile-health application, CALMA, based on dialectical behavioral therapy skills. CALMA was proposed as an adjunct to therapy for the reduction of non-suicidal and suicidal self-injury behaviors. A parallel design was used to compare the intervention group (DBT + CALMA) and the comparison group (DBT). Patients were randomized based on their groups following a randomized cluster design. After treatment, patients completed a follow-up assessment four weeks later. Each cluster was represented by a different DBT Skills Training Group offered weekly at FORO Foundation for Mental Health. Six DBT Skills Training groups were randomized to the intervention or comparison group. Twenty-one individuals met inclusion criteria and eighteen were included in the analysis. Acceptability was measured with the User Experience Questionnaire short version (UEQ-s) and preliminary efficacy with the Self-injurious thoughts and behaviors interview (SITBI). CALMA shows good acceptability to be used as an adjunct to therapy specific to the reduction of suicidal and non-suicidal self-directed violence. Evidence for preliminary efficacy included a high probability of decreased in more behaviors evaluated with the SITBI pre- and post-intervention for the group that received CALMA as compared to the comparison group. Our study provides initial evidence for the effectiveness and acceptability of CALMA. Future studies scaling up this intervention in a larger number of participants are necessary. CALMA may be especially useful in low and middle-income Latin American countries to improve access to evidence-based interventions openly available in Spanish and free to download.HighlightsCALMA is a DBT-based app aimed to reduce non-suicidal and suicidal self-directed violence.The app showed good acceptability by usersA high probability of decrease in suicidal ideation, suicidal plan, suicidal gesture, thoughts about NSSI and NSSI pre- and post-intervention was observed.

[Development of CALMA: A mobile APP for the prevention of suicide in adolescents and youth]. / Desarrollo de CALMA: una aplicación para dispositivos móviles inteligentes para la prevención del suicidio en adolescentes y jóvenes.

During the last 15 years, the suicide rate has doubled among individuals aged between 15 and 24 years in Argentina. This marks the need to develop new strategies for suicide prevention among this age group. Smartphones have become a good platform to provide evidence-based interventions universally, inexpensively and quickly. In particular, there is a high penetration of these devices locally and an acceptance of this technology among young people. In this article, the theoretical basis, as well as the technical design, and safety aspects used for the development of CALMA are described. CALMA is the frst Spanish tool-based mobile app for smartphones, which interacts with the user providing tools based on dialectical behavioral therapy (DBT) for the management of crisis situations and thus preventing suicide among adolescents and young people. CALMA also provides information, promoting activities aimed to reduce one's vulnerability in order to prevent new crises, and psychoeducational content about suicide and its prevention. The app was designed for teenagers and young people. It is available for free in Argentina since May 2017 and works with Android and iOS.