Self-Injurious BehaviorNCT05453370
CALMA App as an Adjunct to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injurious Behaviors in Adolescents
A study testing CALMA m-health app and Treatment As Usual (TAU) in people with Self-Injurious Behavior, run by University of Buenos Aires at 4 sites in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Self-Injurious Behavior
- What is being tested?
- CALMA m-health app and Treatment As Usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesArgentina
- Study dates
- 24 Feb 2022to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Argentina4 sites, 4 recruiting
- Recruiting
Pedro de Elizalde Children's General Hospital
City of Buenos Aires, Buenos Aires, 1270
Eliana B Papavero, MD, +5491150099653, eliana.papavero@gmail.com
Adriana Ingratta, MD
- Recruiting
Institute of Pharmacology of the School of Medicine of the University of Buenos Aires
City of Buenos Aires, Buenos Aires, C1121 ABG
Andrea Errasti, BA, PhD, +54 (11) 5285-3352, institutodefarmacologia@fmed.uba.ar
Eliana B Papavero, MD
- Recruiting
Interzonal Acute Hospital "San Roque" de Gonnet
La Plata, Buenos Aires, B1897
Elisa Besoky, MD, +5492213546345, e.besoky@gmail.com
Elisa Besoky, MD
- Recruiting
Children's Hospital "Sor María Ludovica"
La Plata, Buenos Aires, B1904CSI
Lucia Martinez Barone, MD, +5492215457109, lumartinezb28@gmail.com
Lucia Martinez Barone, MD
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- CALMA m-health app, Treatment As Usual (TAU)
- Keywords
- Self-Injurious Behavior, Mobile Applications, Dialectical Behavior Therapy, Suicide Prevention
- Medical subject headings
- Self-Injurious Behavior, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALMA m-health appDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be assessed at four timepoints: day-0 (baseline), day-30, day-60 and day-90.
Secondary outcomes (2)
Levels of Emotional Dysregulation
Emotional dysregulation will be quantified with the Spanish version of the Emotional Regulation Difficulties Scale (DERS). It has 36 items with a Likert-type response format (from 1 = almost never to 5 = almost always) and a six-factor structure: 1) Impulse control difficulties; 2) Limited access to emotional regulation strategies; 3) Non-acceptance of emotional responses; 4) Difficulty engaging in goal-directed behavior; 5) Lack of emotional awareness; 6) Lack of emotional clarity. The DERS has previously been used in pre- and post-intervention studies as an emotional dysregulation state variable to assess effectiveness. This variable has eleven reverse-scored items and will be considered as a quantitative variable (minimum value = 80; maximum value = 136). Higher scores suggest greater problems with emotion regulation.
Measured: Participants will be assessed at two timepoints: day-0 (baseline) and day-90.
Levels of Engagement of the app.
The use of the app will be obtained and recorded via an objective measure recorded from the participant's phone number. Specifically, use will be considered when at least one of the following features of CALMA is used during the study period: opened a "Tips", arrived at the "Emergency Card", finished a crisis (due to success or abandonment), opened a notification, added a contact, reviewed their "Moments", added a picture or content to their "Moments", closed the app while it was in crisis and ended a crisis successfully. Patients will be defined as "users" of the app if they met the following criteria: subjectively reported using the app in the survey and used at least one feature recorded by our objective measures.
Measured: Participants will be assessed at three timepoints: day-30, day-60, and day-90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start24 Feb 2022
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Self-Injurious BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demian Emanuel Rodante, University of Buenos Aires
- Investigators
- Demián E Rodante, MD, MsC, Principal investigator, Institute of Pharmacology, School of Medicine, University of Buenos AiresFederico M Daray, MD, MsC, PhD, Study director, Institute of Pharmacology, School of Medicine, University of Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453370
- Sponsor's protocol ID
- 884
- Status last verified
- May 2023
- First submitted
- 19 Jun 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30605196Rodante 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.
PubMed 33073745Rodante 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.
PubMed 37547219
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05453370
- Acronym / sponsor ID
- 884
- Conditions
- Self-Injurious Behavior
- Keywords
- Self-Injurious Behavior, Mobile Applications, Dialectical Behavior Therapy, Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Buenos AiresUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| CALMA app | Experimental | Device: CALMA m-health appthe 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 As Usual (TAU) | Other | Other: 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALMA m-health appCALMA 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. | Device | CALMA app |
| 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. | Other | Treatment As Usual (TAU) |
Primary outcome
Change in Frequency of Suicidal and Non-Suicidal Self-Injurious Behaviors.
Time frame: Participants will be assessed at four timepoints: day-0 (baseline), day-30, day-60 and day-90.
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.
2 secondary outcomes
Levels of Emotional Dysregulation
Time frame: Participants will be assessed at two timepoints: day-0 (baseline) and day-90.
Levels of Engagement of the app.
Time frame: Participants will be assessed at three timepoints: day-30, day-60, and day-90.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 30605196Daray 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.
- Background: PubMed 33073745Rodante 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.
- Derived from this study: PubMed 37547219Rodante 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.
- Official educational and non-profit web page of the CALMA app where the functioning of the app is described.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demián E Rodante, MD, MsC principal investigator
Institute of Pharmacology, School of Medicine, University of Buenos Aires
Federico M Daray, MD, MsC, PhD study director
Institute of Pharmacology, School of Medicine, University of Buenos Aires
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALMA m-health app and Treatment As Usual (TAU) in people with Self-Injurious Behavior, run by University of Buenos Aires at 4 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Demián E Rodante, MD, MsC (+54 9 (11) 61911448, drodante@fmed.ubar.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frequency of Suicidal and Non-Suicidal Self-Injurious Behaviors. (time frame: Participants will be assessed at four timepoints: day-0 (baseline), day-30, day-60 and day-90.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453370, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.