CALMA App as an Adjunct to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injurious Behaviors in Adolescents
NCT ID: NCT05453370
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
58 participants
INTERVENTIONAL
2022-02-24
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Supplementing Brief Psychotherapy With a Mobile App
NCT05867316
Pilot Trial of Mobile Technology for Adolescent Suicidality
NCT06454136
Mobile Technology for Reducing and Preventing Adolescent Suicide
NCT04896593
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial
NCT05202756
Promoting Safety Plan and Coping Strategy Use Among Adults With Suicidal Thoughts
NCT05791643
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CALMA app
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.
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.
Treatment As Usual (TAU)
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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
10 Years
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Buenos Aires
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Demian Emanuel Rodante
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Demián E Rodante, MD, MsC
Role: PRINCIPAL_INVESTIGATOR
Institute of Pharmacology, School of Medicine, University of Buenos Aires
Federico M Daray, MD, MsC, PhD
Role: STUDY_DIRECTOR
Institute of Pharmacology, School of Medicine, University of Buenos Aires
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pedro de Elizalde Children's General Hospital
City of Buenos Aires, Buenos Aires, Argentina
Institute of Pharmacology of the School of Medicine of the University of Buenos Aires
City of Buenos Aires, Buenos Aires, Argentina
Interzonal Acute Hospital "San Roque" de Gonnet
La Plata, Buenos Aires, Argentina
Children's Hospital "Sor María Ludovica"
La Plata, Buenos Aires, Argentina
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Official educational and non-profit web page of the CALMA app where the functioning of the app is described.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
884
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.