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

University of Buenos Aires

Status: Enrolling

Conditions: Self-Injurious Behavior

Treatments: Other: Treatment As Usual (TAU); Device: CALMA m-health app

Study type: Interventional

Funder types: Other

Identifiers

NCT05453370

884

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients from 10 to 19 years old who come on an outpatient basis or have been hospitalized in Mental Health Services
• Have a smartphone where the application can be installed and used are eligible to participate in the study
• Have attempted suicide, or exhibited a suicidal gesture or self-injurious behavior (according to the SITBI definition) in the last month before entering the study
• Agree to give their informed consent and their guardian agrees to sign your informed consent

Exclusion criteria

• If the participant plans not to continue the treatment in the next 3 months or
• Has an inability to provide assent/consent for cognitive or language reasons
• Do not have the functional capacity to use the application, which will be operationally determined by a score below 30 on the Self-Care motor domain, below 10 on the Communication cognitive domain or below 14 on the Cognitive domain of Social Knowledge in the Functional Independence Measurement scale (FIM).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

CALMA app

Experimental group

Description:

the arm will receive CALMA app and continue with the usual treatment in a mental health service of a public hospital during the 3 months of the study. In the first interview, the CALMA application will be downloaded to the participant's smartphone. In each follow-up interview (30-days and 60-days), the use of the app will be reinforced.

Treatment:

Device: CALMA m-health app

Treatment As Usual (TAU)

Other group

Description:

the arm will not receive the app and will continue with the usual treatment in a mental health service of a public hospital during the 3 months of the study.

Treatment:

Other: Treatment As Usual (TAU)