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

NCT05453370 | Unknown

• 1 other identifier: 884
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Self-Injurious Behavior

Keywords

Self-Injurious Behavior; Mobile Applications; Dialectical Behavior Therapy; Suicide Prevention

Outcome Measures

Primary Outcomes (1)

• Change in Frequency of Suicidal and Non-Suicidal Self-Injurious Behaviors.

  Suicidal behavior will be assessed using the Spanish version of the Self-Injurious Thoughts and Behaviors Interview (SITBI). This is a structured interview consisting of 169 items divided into 5 modules that examine the presence, frequency and characteristics of 5 types of self-injurious behavior: a) suicidal ideation; b) suicide plans; c) suicidal gestures; d) suicide attempts and e) self-harm. The SITBI conceptualizes suicide risk on a continuum, starting with suicide ideation (SI) ("thoughts of killing yourself?"), possibly accompanied by a suicide plan ("think about how you might kill yourself \[e.g., taking pills, shooting yourself\] or work out a plan of how to kill yourself?") and in some cases by suicide attempt (SA) ("made a suicide attempt \[i.e., purposefully hurt yourself with at least some intent to die\]?"). The construction of the questions in the original SITBI are consistent with the commonly accepted definitions of each type of behavior.

  Participants will be assessed at four timepoints: day-0 (baseline), day-30, day-60 and day-90.

Secondary Outcomes (2)

• Levels of Emotional Dysregulation

  Participants will be assessed at two timepoints: day-0 (baseline) and day-90.

• Levels of Engagement of the app.

  Participants will be assessed at three timepoints: day-30, day-60, and day-90.

Other Outcomes (2)

• Time (days) to psychiatric admission

  from the date of enrollment to the date of the first psychiatric hospitalization for a self-injurious behavior up to 3 months. Participants will be assessed at the three follow-up timepoints: day-30, day-60, and day-90.

• Sociodemographic variables

  Participants will be assessed at day-0 (baseline).

Study Arms (2)

CALMA app

EXPERIMENTAL

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.

Device: CALMA m-health app

Treatment As Usual (TAU)

OTHER

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.

Other: Treatment As Usual (TAU)

Interventions

CALMA m-health app DEVICE

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.

CALMA app

Treatment As Usual (TAU) OTHER

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.

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Buenos Aires: lead

Study Sites (4)

Pedro de Elizalde Children's General Hospital

City of Buenos Aires, Buenos Aires, 1270, Argentina

RECRUITING

Institute of Pharmacology of the School of Medicine of the University of Buenos Aires

City of Buenos Aires, Buenos Aires, C1121 ABG, Argentina

RECRUITING

Interzonal Acute Hospital "San Roque" de Gonnet

La Plata, Buenos Aires, B1897, Argentina

RECRUITING

Children's Hospital "Sor María Ludovica"

La Plata, Buenos Aires, B1904CSI, Argentina

RECRUITING

Related Publications (3)

• Daray FM, Olivera Fedi RH, Rodante DE. [Development of CALMA: A mobile APP for the prevention of suicide in adolescents and youth]. Vertex. 2018 Jan;29(137):55-64. Spanish.

  PMID: 30605196 BACKGROUND

• Rodante DE, Kaplan MI, Olivera Fedi R, Gagliesi P, Pascali A, Jose Quintero PS, Compte EJ, Perez AI, Weinstein M, Chiapella LC, Daray FM. 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. Arch Suicide Res. 2022 Apr-Jun;26(2):801-818. doi: 10.1080/13811118.2020.1834476. Epub 2020 Oct 18.

  PMID: 33073745 BACKGROUND

• Rodante DE, Chiapella LC, Olivera Fedi R, Papavero EB, Lavoie KL, Daray FM. 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. Front Psychiatry. 2023 Jul 20;14:1087097. doi: 10.3389/fpsyt.2023.1087097. eCollection 2023.

  PMID: 37547219 DERIVED

Related Links

• Official educational and non-profit web page of the CALMA app where the functioning of the app is described.

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide Prevention

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Study Officials

• Demián E Rodante, MD, MsC

  Institute of Pharmacology, School of Medicine, University of Buenos Aires

  PRINCIPAL INVESTIGATOR

• Federico M Daray, MD, MsC, PhD

  Institute of Pharmacology, School of Medicine, University of Buenos Aires

  STUDY DIRECTOR

Central Study Contacts

Demián E Rodante, MD, MsC

CONTACT

+54 9 (11) 61911448; drodante@fmed.ubar.ar

Federico M Daray, MD, MsC, PhD

CONTACT

+54 9 (11) 63597476; fdaray@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: July 12, 2022
• Study Start: February 24, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (4)