Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: 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
Brief 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.