NCT05453370

CALMA App as an Adjunct to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injurious Behaviors in Adolescents

A Randomized 3-Month, Parallel-Group, Controlled Trial of CALMA M-Health App as an Adjunct to Therapy for the Reduction of Suicidal and Non-Suicidal Self-Injurious Behaviors in Adolescents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: University of Buenos Aires · Academic / Other
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

Suicide in the second cause of death in subjects between 15 and 24 years of age. Despite the efficacy of interventions for the management of suicidal crises observed in some clinical trials, a crucial aspect for their effectiveness is accessibility. This leaves little time to intervene during the suicidal process. New platforms to provide evidence-based interventions, universally, economically, and quickly are needed. Smartphones appear to be a good alternative considering the high penetration of these devices locally. The research group carried out a pilot randomized controlled cluster trial with four weeks of follow-up that provided initial evidence on the safety and acceptability of the app for reducing self-injurious thoughts and behaviors when used as an adjunct to conventional Dialectical Behavioral Therapy (DBT). This study conducted with a group of patients who were already undergoing DBT treatment program, and have shown good acceptability of CALMA as an adjunct to therapy targeting suicidal and non-suicidal self-injury behaviors. Although effectiveness was not the main outcome, results revealed a high probability to decrease suicidal outcomes including ideation, suicidal behaviors, Non-Suicidal Self-Injury (NSSI) and thoughts about NSSI in the group that received CALMA compared to the comparison group. No specific app for adolescents and young people is available in Spanish. The research group developed CALMA (the Spanish word for "calm"), the first user-interactive mobile app in Spanish. It provides evidence-based tools to manage a suicidal or non-suicidal self-directed violence crisis. CALMA also interacts with the user between crises by promoting activities that reduce their vulnerability to suicide by provide psychoeducation about suicide and its prevention. Based on these encouraging initial findings, in this project the investigators propose to scale the intervention to a larger group of patients, focus it on adolescents and including public hospitals not specialized in DBT. This is a parallel group, two-arm randomized controlled trial design, which will employ an intervention condition (CALMA app) and a control condition (Treatment as usual) with a 3-month follow-up for each participant, to evaluate the effectiveness, safety and acceptability of CALMA, a suicide prevention app for smartphones, to reduce the frequency of self-injurious thoughts and behaviors in adolescents who are assisted in a Mental Health service of three Public Hospitals.

Detailed description

Suicide and suicidal behaviors are among the leading causes of death and injury worldwide. Although in Argentina the overall suicide rate has remained relatively stable in the last 15 years, when analyzing the rates by age group, it is observed that in that same period there was a gradual and sustained growth in the suicide rate in subjects between 15 and 24 years of age. Despite the efficacy of interventions for the management of suicidal crises observed in some clinical trials, a crucial aspect for their effectiveness in daily practice is accessibility, that is, the availability of the intervention at the time of the crisis. This leaves little time to intervene during the suicidal process. This is why, beyond employing effective interventions to prevent suicide, it is necessary that they be quickly accessible at the time of crisis. New platforms to provide evidence-based interventions, universally, economically, and quickly are needed. Smartphones appear to be a good alternative considering the high penetration of these devices locally. The development of mobile applications (apps) for the prevention of suicidal behavior is recent. The research group carried out a pilot randomized controlled cluster trial with four weeks of follow-up that provided initial evidence on the safety and acceptability of the app for reducing self-injurious thoughts and behaviors when used as an adjunct to conventional Dialectical Behavioral Therapy (DBT). This study conducted with a group of patients who were already undergoing DBT treatment program, have shown good acceptability of CALMA as an adjunct to therapy targeting suicidal and non-suicidal self-injury behaviors. Furthermore, although effectiveness was not the main outcome, results revealed a high probability to decrease suicidal outcomes including ideation, suicidal behaviors, Non-Suicidal Self-Injury (NSSI) and thoughts about NSSI in the group that received CALMA compared to the comparison group To investigators knowledge, no specific app for adolescents and young people is available in Spanish. The research group developed CALMA (the Spanish word for "calm"), the first user-interactive mobile app in Spanish. CALMA provides evidence-based tools to manage a suicidal or non-suicidal self-directed violence crisis with the goal of preventing death by suicide. CALMA also interacts with the user between crises by promoting activities that reduce their vulnerability to suicide by provide psychoeducation about suicide and its prevention. Based on these encouraging initial findings, in this project the investigators propose to scale the intervention to a larger group of patients, focus it on adolescents and include public hospitals not specialized in DBT. The investigators are conducting a parallel group, two-arm randomized controlled trial design, which will employ an intervention condition (CALMA app) and a control condition (Treatment as usual -TAU) with a 3-month follow-up for each participant, to evaluate the effectiveness, safety and acceptability of CALMA, a suicide prevention app for smartphones, to reduce the frequency of self-injurious thoughts and behaviors in adolescents who are assisted in a Mental Health service of three Public Hospitals.

Conditions

• Self-Injurious Behavior

Interventions

Type	Name	Description
DEVICE	CALMA m-health app	CALMA is an app for smartphones that provides evidence-based tools to prevent suicide. Out of Crisis modality consists of 4 sections: Moments, Agenda, Profile and Tips. The I need help modality uses DBT skills presented in a card format. The Problem-solving Card is the first one showed and helps the user to know if the problem that triggered the crisis can be addressed through a problem-solving strategy. If not, the next step is to use the CALMA thermometer (to identify the intensity of the emotion) and the DBT Skills Cards. They are based fundamentally in two groups of DBT skills, emotional regulation and distress tolerance. If distress worsens or does not diminish the Emergency Card is activated, offering the user the option to make one or several calls to emergency contacts and providing the option to use the geolocation function to show all emergency services near the user's location so that he/she can consult personally. All participants will also receive mental health treatment.
OTHER	Treatment As Usual (TAU)	Participants who do not receive the application will continue the usual mental health treatment (psychotherapeutic and/or psychopharmacological) by their usual treating professionals throughout the duration of the study.

Timeline

• Start date: 2022-02-24
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2022-07-12
• Last updated: 2023-05-17

Locations

4 sites across 1 country: Argentina