Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-09-08
First Post:
2021-02-21
Brief Title:
Smartphone-based Ecological Momentary Intervention for Suicide Prevention a Randomised Clinical Trial
Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Organization:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Overview
Official Title:
Smartphone-based Ecological Momentary Intervention for Secondary Prevention of Suicidal Thoughts and Behavior a Randomised Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SmartCrisis2
Brief Summary:
Introduction Suicide is one of the leading public health issues worldwide Mobile health can help us to combat suicide through monitoring and treatment The SmartCrisis 20 randomized clinical trial aims to evaluate the effectiveness of a smartphone-based Ecological Momentary Intervention to prevent suicidal thoughts and behaviour
Methods and analysis The SmartCrisis 20 study is a randomized clinical trial with two parallel groups conducted among patients with a history of suicidal behaviour treated at the University Hospital Fundación Jiménez Díaz The intervention group will be monitored using Ecological Momentary Assessment and will receive an Ecological Momentary Intervention called SmartSafe in addition to their treatment as usual TAU TAU will consist of psychiatric follow-up of the patient scheduled appointments with a psychiatrist in our outpatient Suicide Prevention clinic with predetermined clinical appointments according to the Brief Intervention Contact recommendations 1 2 4 7 and 11 weeks and 4 6 9 and 12 months The control group would receive TAU and be monitored using EMA
Ethics and dissemination This study has been approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz It is expected that in the near future the mobile applications MEmind and eB2 can be implemented in routine clinical practice Results will be disseminated through peer-reviewed journals and psychiatric congresses
Methods and analysis The SmartCrisis 20 study is a randomized clinical trial with two parallel groups conducted among patients with a history of suicidal behaviour treated at the University Hospital Fundación Jiménez Díaz The intervention group will be monitored using Ecological Momentary Assessment and will receive an Ecological Momentary Intervention called SmartSafe in addition to their treatment as usual TAU TAU will consist of psychiatric follow-up of the patient scheduled appointments with a psychiatrist in our outpatient Suicide Prevention clinic with predetermined clinical appointments according to the Brief Intervention Contact recommendations 1 2 4 7 and 11 weeks and 4 6 9 and 12 months The control group would receive TAU and be monitored using EMA
Ethics and dissemination This study has been approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz It is expected that in the near future the mobile applications MEmind and eB2 can be implemented in routine clinical practice Results will be disseminated through peer-reviewed journals and psychiatric congresses
Detailed Description:
Introduction Over 800000 die every year by suicide while suicide attempts are estimated to be 20 times more frequent Suicidal ideation SI is estimated to affect 2 of the population Suicidal thoughts and behaviours STB increase the risk of death by suicide impair peoples quality of life and result in high healthcare costs
New technologies can help us in the management and prevention of STB Among other advantages these devices open the possibility of implementing smartphone-based real-time monitoring There are two main types of smartphone-based monitoring active and passive The active mode is also known as Ecological Momentary Assessment EMA EMA involves asking daily questions resulting in real-time responses in the patients usual environment EMA provides a more accurate picture of the emotional and cognitive context in which SI appears offering us the opportunity to identify its immediate predictors
Passive monitoring -also called passive EMA- involves using the mobile phones native sensors to collect information such as physical activity mobility or sleep which can be useful as proxy factors for mental state The combination of active and passive monitoring produces valuable information to characterize peoples behaviour giving rise to what is known as an individuals digital phenotype Barrigón et al 2019 As it does not require patient effort passive EMA can increase the acceptability of monitoring and counteract the so-called EMA fatigue which occurs when patients stop answering EMA questions
A considerable number of studies have applied EMA technology to suicide research In contrast passive EMA has been used scarcely in suicidology
A further step is to exploit EMAs potential to design digital therapeutic tools providing continuous support in the patients usual environment This is known as Ecological Momentary Intervention EMI EMIs can be a useful add-on to traditional treatment thanks to their 24-hour availability low cost and the possibility of continuing follow-up in a non-presential manner Some studies have explored the effectiveness of EMI on suicidal behaviour showing good acceptability and a reduction in SI after the intervention
This is an up-and-coming area that may contribute to suicide prevention which has not yet received sufficient attention in the scientific literature
The SmartCrisis 20 randomized clinical trial aims to evaluate the effectiveness of an Ecological Momentary Intervention EMI combined with smartphone-based monitoring for the prevention of STB in patients at high risk of suicide
Our hypotheses are as follows
1 Beforeafter comparison In the intervention group there will be a significant reduction in STB and an improvement in functionality and quality of life after the follow-up period
2 Comparison with control group The intervention group will have a greater reduction in STB and a greater improvement in functioning and quality of life than the control group
3 Feasibility and acceptability The use of the eB2 and MEmind mobile applications will be feasible and well accepted by psychiatric patients
Methods and analysis Our sample will consist of patients with a history of recent STB treated at either one of these five locations University Hospital Fundación Jiménez Díaz Madrid Spain Rey Juan Carlos Hospital Móstoles Spain and General Hospital of Villalba Villalba Spain Centre hospitalier universitaire Montpellier Montpellier France or Nîmes University Hospital Nîmes France
Sample size calculation was performed using GPower software version 31 Based on previous clinical trials exploring the ability of crisis management interventions to reduce SI in the mid-term Ducasse et al 2018 the investigators estimated a target sample size enough to have 80 power to detect between-group differences of 6-7 points on the Columbia Suicide Severity Rating Scale 25 decrease in the intensity of SI in the intervention group The alpha error was set at 5 and the power at 80 A dropout rate of 20 and a randomization imbalance of 10 were assummed With these settings the investigators estimated that a total of 220 participants 110 in each arm were needed
Before starting the clinical trial a pilot will be conducted in approximately 40 patients will be recruited All of them will receive the SmartSafe EMI and be monitored using active and passive EMA These patients will not be part of the final analysis After three months of follow-up when all participants have had time to try out the application a focus group will be held between the research team the attending clinicians and the patients in order to get their opinion on the intervention and to identify possible technical and human failures that could be improved before starting the clinical trial
Once the clinical trial recruitment starts attending psychiatrists will check their patients eligibility during their regular appointment explain the project in detail and invite them to participate If patients agree to participate they will be asked to sign the informed consent after which they will be randomly assigned to the intervention group EMI EMA TAU or the control group EMA TAU
At the baseline interview a psychiatrist will assess the characteristics of the last suicidal event using the Brief Suicide Protocol which has been previously published and they will set up the SmartSafe intervention according to the patients preferences Next a trained research assistant blind to the patients assigned arm will administer the standardized questionnaires detailed below
Patients will be followed for one year with face-to-face visits at six months and one year The attending psychiatrist will also check for STB using the Columbia Suicide Severity Rating Scale CSSRS at the 4th week 11th week and 9th-month appointments If participants cannot attend the follow-up visits the assessments will be performed by phone All questionnaires will be completed via the MEmind website
The piloting is expected to take place between June and December 2021 Recruitment is expected to commence in January 2022 and to be completed by June 2023 Data collection will take place from 2022 to 2024 Data analysis will take place from 2022 to 2024 The investigators expect to publish partial results by the end of 2022 and final results by early 2025
Digital monitoring will be performed using EMA Two EMA modalities will be used active using the MEmind app and passive using the eB2 app
The MEmind app asks short daily questions that appear on the mobile screen Each day 2-4 random questions will be asked at random times respecting sleep hours from the pool of 34 questions that make up the questionnaire based on the Salzburg Suicide Questionnaire
The EMA questions belong to 6 categories
Suicidality 5 questions
Non-suicidal self injury 2 questions
Affect 9 questions
Interpersonal experiences 11 questions
Sleep 4 questions
Eating 3 questions The eB2 app runs in the background and does not require user intervention It collects real-time information from the patients mobile phone location mobility smartphone usage and sleep stores it and downloads it to a server All the information collected from the phone is transformed with a hash function This hash function makes it impossible to know the original data but allows the analysis of behavioral patterns
In addition to the smartphone-based monitoring another digital assessment will be carried out a neuropsychological assessment using a previously validated Virtual Reality environment the Spheres Shield Maze Task This tool recreates a maze with different tasks to assess decision-making impulsivity attention and cognitive inhibition
Non-digital assessments will be carried out by attending psychiatrists and research assistants all of them previously trained All questionnaires will be completed on the MEmind website which allows for easy completion and immediate uploading to databases
Some of the main tools used will be the following
The Brief Suicide Questionnaire BSQ will be used to characterize the index event that motivated inclusion in the study suicide attempt or emergency referral for SI It includes questions on lethality method and surrounding circumstances of the attempt and lifetime history of suicidal behaviour
The CSSRS scale will be used to measure STB both at baseline and follow-up visits
The investigators will verify suicide attempts and deaths by suicide through our organizations digital medical records called the Casiopea software which integrates information on ER visits hospitalizations and visits to specialist consultations If a patient cannot be located and there is no information in their record the investigators will contact the patients family telephone number The investigators will also request access to the Spanish register of deaths and causes of death of the Instituto Nacional de Estadística National Statistics Institute
At the six-month follow-up visit patients will complete a qualitative satisfaction survey with the following questions referring to each of the applications used MEmind and eB2 and the face-to-face assessments
Traditional statistical analyses will be performed using SPSS 240 statistical software To compare SI at baseline with SI at the end of follow-up CSSRS score paired samples t-tests will be used To compare the improvement in SI after follow-up between the intervention group and the control group an independent samples t-test will be used
Survival curves time to a new suicidal event will be calculated using the Kaplan-Meier test The intervention groups survival curves and the control group will be compared using the log rank test To assess the projects feasibility participation rate retention and percentage of EMA questions answered will be calculated
Binary logistic regression will be used to explore the correlation between the study variables obtaining crude and age- and sex-adjusted ORs A multivariate regression model will also be built to assess the unique strength of the association of the variables Cox regression analysis will be performed to explore variables associated with survival time time until next event All tests will be two-tailed with a significance level of p005 and 95 confidence intervals
In addition to the traditional analyses with the Signal Theory Department of the Carlos III Universitys support unsupervised analyses will be carried out using machine learning techniques to create behavioral models and patient activity profiles
New technologies can help us in the management and prevention of STB Among other advantages these devices open the possibility of implementing smartphone-based real-time monitoring There are two main types of smartphone-based monitoring active and passive The active mode is also known as Ecological Momentary Assessment EMA EMA involves asking daily questions resulting in real-time responses in the patients usual environment EMA provides a more accurate picture of the emotional and cognitive context in which SI appears offering us the opportunity to identify its immediate predictors
Passive monitoring -also called passive EMA- involves using the mobile phones native sensors to collect information such as physical activity mobility or sleep which can be useful as proxy factors for mental state The combination of active and passive monitoring produces valuable information to characterize peoples behaviour giving rise to what is known as an individuals digital phenotype Barrigón et al 2019 As it does not require patient effort passive EMA can increase the acceptability of monitoring and counteract the so-called EMA fatigue which occurs when patients stop answering EMA questions
A considerable number of studies have applied EMA technology to suicide research In contrast passive EMA has been used scarcely in suicidology
A further step is to exploit EMAs potential to design digital therapeutic tools providing continuous support in the patients usual environment This is known as Ecological Momentary Intervention EMI EMIs can be a useful add-on to traditional treatment thanks to their 24-hour availability low cost and the possibility of continuing follow-up in a non-presential manner Some studies have explored the effectiveness of EMI on suicidal behaviour showing good acceptability and a reduction in SI after the intervention
This is an up-and-coming area that may contribute to suicide prevention which has not yet received sufficient attention in the scientific literature
The SmartCrisis 20 randomized clinical trial aims to evaluate the effectiveness of an Ecological Momentary Intervention EMI combined with smartphone-based monitoring for the prevention of STB in patients at high risk of suicide
Our hypotheses are as follows
1 Beforeafter comparison In the intervention group there will be a significant reduction in STB and an improvement in functionality and quality of life after the follow-up period
2 Comparison with control group The intervention group will have a greater reduction in STB and a greater improvement in functioning and quality of life than the control group
3 Feasibility and acceptability The use of the eB2 and MEmind mobile applications will be feasible and well accepted by psychiatric patients
Methods and analysis Our sample will consist of patients with a history of recent STB treated at either one of these five locations University Hospital Fundación Jiménez Díaz Madrid Spain Rey Juan Carlos Hospital Móstoles Spain and General Hospital of Villalba Villalba Spain Centre hospitalier universitaire Montpellier Montpellier France or Nîmes University Hospital Nîmes France
Sample size calculation was performed using GPower software version 31 Based on previous clinical trials exploring the ability of crisis management interventions to reduce SI in the mid-term Ducasse et al 2018 the investigators estimated a target sample size enough to have 80 power to detect between-group differences of 6-7 points on the Columbia Suicide Severity Rating Scale 25 decrease in the intensity of SI in the intervention group The alpha error was set at 5 and the power at 80 A dropout rate of 20 and a randomization imbalance of 10 were assummed With these settings the investigators estimated that a total of 220 participants 110 in each arm were needed
Before starting the clinical trial a pilot will be conducted in approximately 40 patients will be recruited All of them will receive the SmartSafe EMI and be monitored using active and passive EMA These patients will not be part of the final analysis After three months of follow-up when all participants have had time to try out the application a focus group will be held between the research team the attending clinicians and the patients in order to get their opinion on the intervention and to identify possible technical and human failures that could be improved before starting the clinical trial
Once the clinical trial recruitment starts attending psychiatrists will check their patients eligibility during their regular appointment explain the project in detail and invite them to participate If patients agree to participate they will be asked to sign the informed consent after which they will be randomly assigned to the intervention group EMI EMA TAU or the control group EMA TAU
At the baseline interview a psychiatrist will assess the characteristics of the last suicidal event using the Brief Suicide Protocol which has been previously published and they will set up the SmartSafe intervention according to the patients preferences Next a trained research assistant blind to the patients assigned arm will administer the standardized questionnaires detailed below
Patients will be followed for one year with face-to-face visits at six months and one year The attending psychiatrist will also check for STB using the Columbia Suicide Severity Rating Scale CSSRS at the 4th week 11th week and 9th-month appointments If participants cannot attend the follow-up visits the assessments will be performed by phone All questionnaires will be completed via the MEmind website
The piloting is expected to take place between June and December 2021 Recruitment is expected to commence in January 2022 and to be completed by June 2023 Data collection will take place from 2022 to 2024 Data analysis will take place from 2022 to 2024 The investigators expect to publish partial results by the end of 2022 and final results by early 2025
Digital monitoring will be performed using EMA Two EMA modalities will be used active using the MEmind app and passive using the eB2 app
The MEmind app asks short daily questions that appear on the mobile screen Each day 2-4 random questions will be asked at random times respecting sleep hours from the pool of 34 questions that make up the questionnaire based on the Salzburg Suicide Questionnaire
The EMA questions belong to 6 categories
Suicidality 5 questions
Non-suicidal self injury 2 questions
Affect 9 questions
Interpersonal experiences 11 questions
Sleep 4 questions
Eating 3 questions The eB2 app runs in the background and does not require user intervention It collects real-time information from the patients mobile phone location mobility smartphone usage and sleep stores it and downloads it to a server All the information collected from the phone is transformed with a hash function This hash function makes it impossible to know the original data but allows the analysis of behavioral patterns
In addition to the smartphone-based monitoring another digital assessment will be carried out a neuropsychological assessment using a previously validated Virtual Reality environment the Spheres Shield Maze Task This tool recreates a maze with different tasks to assess decision-making impulsivity attention and cognitive inhibition
Non-digital assessments will be carried out by attending psychiatrists and research assistants all of them previously trained All questionnaires will be completed on the MEmind website which allows for easy completion and immediate uploading to databases
Some of the main tools used will be the following
The Brief Suicide Questionnaire BSQ will be used to characterize the index event that motivated inclusion in the study suicide attempt or emergency referral for SI It includes questions on lethality method and surrounding circumstances of the attempt and lifetime history of suicidal behaviour
The CSSRS scale will be used to measure STB both at baseline and follow-up visits
The investigators will verify suicide attempts and deaths by suicide through our organizations digital medical records called the Casiopea software which integrates information on ER visits hospitalizations and visits to specialist consultations If a patient cannot be located and there is no information in their record the investigators will contact the patients family telephone number The investigators will also request access to the Spanish register of deaths and causes of death of the Instituto Nacional de Estadística National Statistics Institute
At the six-month follow-up visit patients will complete a qualitative satisfaction survey with the following questions referring to each of the applications used MEmind and eB2 and the face-to-face assessments
Traditional statistical analyses will be performed using SPSS 240 statistical software To compare SI at baseline with SI at the end of follow-up CSSRS score paired samples t-tests will be used To compare the improvement in SI after follow-up between the intervention group and the control group an independent samples t-test will be used
Survival curves time to a new suicidal event will be calculated using the Kaplan-Meier test The intervention groups survival curves and the control group will be compared using the log rank test To assess the projects feasibility participation rate retention and percentage of EMA questions answered will be calculated
Binary logistic regression will be used to explore the correlation between the study variables obtaining crude and age- and sex-adjusted ORs A multivariate regression model will also be built to assess the unique strength of the association of the variables Cox regression analysis will be performed to explore variables associated with survival time time until next event All tests will be two-tailed with a significance level of p005 and 95 confidence intervals
In addition to the traditional analyses with the Signal Theory Department of the Carlos III Universitys support unsupervised analyses will be carried out using machine learning techniques to create behavioral models and patient activity profiles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None