Cardiac ArrhythmiaNCT04235881
Emotional Regulation in Patients With Implanted Automatic Defibrillator
A study testing Mindfulness-based stress reduction program and App REM volver a casa in people with Cardiac Arrhythmia and Ventricular Fibrillation, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The general objective of the study was to evaluate the impact of two emotional regulation programs, one standardized and face-to-face (MBSR: Mindfulness Based Stress Reduction) and, another, implemented through a mobile phone application (REM_Volver a casa; ERBM_Back home: Emotional Regulation Based on Mindfulness)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrhythmia, Ventricular Fibrillation, Ventricular Tachycardia
- What is being tested?
- Mindfulness-based stress reduction program and App REM volver a casa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2017to 30 May 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years.
- Be a patient of the University Hospital La Paz and have an ICD implanted whose implant was equal to or greater than three months.
- Sufficient knowledge of the Spanish language.
- Have a mobile phone and the ability to handle applications on the phone.
- Availability and sufficient physical conditions to attend mindfulness training in the face-to-face format.
Who cannot join
- Be over 75 years old.
- Be waiting for a heart transplant or other operation related to cardiac pathology.
- Have previous training in mindfulness, unless it had been done before 5 years and had not been practiced since then.
- Being diagnosed with a serious mental disorder and being in an acute symptomatic period of the disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Mindfulness Training on the Quality of Life of Patients With Implantable Automatic Defibrillator
The general objective of the study was to evaluate the impact of two emotional regulation programs, one standardized and face-to-face (MBSR: Mindfulness Based Stress Reduction) and, another, implemented through a mobile phone application (REM_Volver a casa; ERBM_Back home: Emotional Regulation Based on Mindfulness), on the quality of life, the state emotional and psychological and biological variables associated with stress, in a sample of patients with ICD (implantable cardioverter defibrillator).
The working hypotheses were that after training in emotional regulation, patients with ICD would have better quality of life, lower symptoms of anxiety, depression and hostility, and lower incidence of ventricular arrhythmias than patients in the control group, as well as that there would be no differences between the two tools used for training.
Read the detailed description
The recruitment process of the participants was carried out by telephone, by the medical staff of the arrhythmia's section, who informed the patients the characteristics and objectives of the study.
The sample size was estimated considering an alpha risk of 0.05 and a beta risk of 0.2, in a bilateral contrast, to detect a difference equal to or greater than 10 units in the Quality of life variable. A standard deviation of 20 points and a 20% loss rate were assumed. The estimated n was 237 patients, to distribute in three branches of 79 patients each.
Before beginning the intervention, participants were informed about the research, and were offered the opportunity to ask questions in order to clarify any doubts about it. Next, they were given a Participant Data Collection Notebook. The Notebook included the information on the investigation and the Informed Consent, to be completed and signed; the request for demographic data (age, gender, educational level, etc.); and, the four questionnaires used to assess the psychological variables of study: SF-36 (quality of life), HADS (anxiety and depression), STAXI (hostility) and FFMQ (Mindfulness) For the descriptive analysis, the number of subjects and the corresponding percentage was used in the qualitative variables. In the quantitative variables the mean and standard deviation were used when the variables adjusted to the normal distribution; otherwise, the median and interquartile range (first and third quartile) were used. The normality test used was the Shapiro-Wilk.
In the hypothesis contrast of the pre-post values, of the variables with distribution adjusted to normal, the Student´s t statistic was used for paired data; For the variables whose distribution did not conform to normal, the Wilcoxon Test was chosen.
For the contrast of inter-group hypothesis (independent samples with distribution not adjusted to normal), the Mann Whitney test was used.
For the statistical analysis of data, the SPSS program, version 20, was used.
- Being tested
- Mindfulness-based stress reduction program, App REM volver a casa
- Keywords
- Implantable automatic defibrillator, Emotional regulation, MBSR, App, Quality of life, Mindfulness, Anxiety, Depression
- Medical subject headings
- Arrhythmias, Cardiac, Ventricular Fibrillation, Tachycardia, Ventricular, Emotional Regulation, Alzheimer Disease, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction programBehavioural
Mindfulness training through an adaptation of the standardized MBSR program. This program was conducted in person and in a group, with a maximum of 25 participants per group and a total duration of 8 weeks. The training was carried out in 8 sessions, one each week, with a duration of 2 h each session.
App REM volver a casaBehavioural
The intervention was carried out through the computer application for mobile phone "REM volver a casa". This application has been developed to carry out training in the emotional regulation program based on mindfulness, autonomously. The application is designed to carry out the program in 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MBSR group | Experimental | Enforcement of the standardized program Mindfulness-Based Stress Reduction Receives: Behavioral: Mindfulness-based stress reduction program |
| App group. | Experimental | Enforcement of the emotional regulation program based on mindfulness (ERM) through the mobile phone application REM volver a casa Receives: Behavioral: App REM volver a casa |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
The questionnaire (SF-36: Short Form) uses a Likert scale of 3 or 5 points, with a range of scores from 0 to 100, average of 50 and standard deviation 10.
Measured: In order to assess the change at the Quality of life variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it.
Secondary outcomes (8)
Anxiety and Depression
HADS: Hospital Anxiety and Depression Scale. This scale assess the presence of anxiety or depression. It consists of two sub-scales, of 7 items each, are scored on a Likert scale of 4 points. The cut-off points used for the two scales were: 0 to 7 = no clinical significance; from 8 to 10 = doubtful; from 11 to 14 = moderate; from 15 to 21 = severe.
Measured: In order to assess the change at the anxiety and depression variables, were measured just before starting the mindfulness training program and, eight weeks later, after finishing it.
Anger
STAXI: State-Trait Anger Expression Inventory. Questionnaire used to evaluate the expression of hostility, in terms of personality trait and regarding the circumstantial state at the time of measurement. The scores are represented in standardized T scores: mean of 50 points and a standard deviation of 10 points.
Measured: In order to assess the change at the Anger variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it.
AHR
Average Heart Rate (AHR).These parameters were obtained from the data record of the defibrillator implanted in each patient, and is quantified by beats per minute.
Measured: To assess the change in the AHR variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.
NSVT
Number of Non-Sustained Ventricular Tachycardia (NSVT). These parameters were obtained from the data record of the defibrillator implanted in each patient, and is quantified by whole numbers.
Measured: To assess the change in the NSVT variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.
LVEF
Left Ventricular Ejection Fraction (LVEF). The ejection fraction is the force with which the left ventricle contracts and is related to the patient's prognosis and its symptomatology. This parameter is classified into four levels, according to the percentage.
- Less than 40%: heart failure.
- From 40 to 55%: below normal heart function.
- From 55 to 70%: normal heart function.
- Higher than 75%: can indicate a heart condition.
Measured: The value of this parameter is recorded at the beginning of the study.
FC
Functional Class (FC). The functional class for dyspnea is a classification according to the degree to which patients have the feeling of shortness of breath. The functional classification is determined according to the following four levels:
- Without any limitation of physical activity.
- Slight limitation of physical activity.
- Marked limitation of physical activity.
- Inability to carry out any physical activity without symptoms.
Measured: The value of this parameter is recorded at the beginning of the study.
Number of Shocks
Number of shocks produced by the implantable automatic defibrillator, in each patient. Events (shocks) are determined by their registration in the device (implantable automatic defibrillator). The device has a record in which it stores parameters related to the functioning of the heart and the regulation and control processes performed by the device, among them, the shocks it gives in order to restore a situation of ventricular fibrillation or ventricular arrhythmia. This parameter is quantified by whole numbers.
Measured: The estimated period of evaluation is up to 8 years. The events (shocks) accounted are for the period between the date of implantation of the device and the date of the last data collection, approximately 33 months after the start of the study.
Daily Activity
Number of daily hours of activity, recorded by the implantable automatic defibrillator device. This parameter is quantified in hours.
Measured: To assess the change in the Daily Activity variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start15 Feb 2017
- Primary completion15 Feb 2017
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies 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
- Factorial
- Model description
- The experimental study was developed through a randomized controlled clinical trial, with simple random probabilistic sampling. With a pre-post design, the variables measured in the participants before performing the mindfulness training were measured again at the end of the program, eight weeks later, in order to compare the values of both measurements.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Rodríguez Vega, Doctor, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235881
- Sponsor's protocol ID
- MF_DAI_La_PAZ
- Status last verified
- Nov 2019
- First submitted
- 29 Nov 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindfulness Training on the Quality of Life of Patients With Implantable Automatic Defibrillator
- ClinicalTrials.gov ID
- NCT04235881
- Acronym / sponsor ID
- MF_DAI_La_PAZ
- Keywords
- Implantable automatic defibrillator, Emotional regulation, MBSR, App, Quality of life, Mindfulness, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 22 Jan 2020 (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.
The general objective of the study was to evaluate the impact of two emotional regulation programs, one standardized and face-to-face (MBSR: Mindfulness Based Stress Reduction) and, another, implemented through a mobile phone application (REM_Volver a casa; ERBM_Back home: Emotional Regulation Based on Mindfulness), on the quality of life, the state emotional and psychological and biological variables associated with stress, in a sample of patients with ICD (implantable cardioverter defibrillator).
The working hypotheses were that after training in emotional regulation, patients with ICD would have better quality of life, lower symptoms of anxiety, depression and hostility, and lower incidence of ventricular arrhythmias than patients in the control group, as well as that there would be no differences between the two tools used for training.
Detailed description
The recruitment process of the participants was carried out by telephone, by the medical staff of the arrhythmia's section, who informed the patients the characteristics and objectives of the study.
The sample size was estimated considering an alpha risk of 0.05 and a beta risk of 0.2, in a bilateral contrast, to detect a difference equal to or greater than 10 units in the Quality of life variable. A standard deviation of 20 points and a 20% loss rate were assumed. The estimated n was 237 patients, to distribute in three branches of 79 patients each.
Before beginning the intervention, participants were informed about the research, and were offered the opportunity to ask questions in order to clarify any doubts about it. Next, they were given a Participant Data Collection Notebook. The Notebook included the information on the investigation and the Informed Consent, to be completed and signed; the request for demographic data (age, gender, educational level, etc.); and, the four questionnaires used to assess the psychological variables of study: SF-36 (quality of life), HADS (anxiety and depression), STAXI (hostility) and FFMQ (Mindfulness) For the descriptive analysis, the number of subjects and the corresponding percentage was used in the qualitative variables. In the quantitative variables the mean and standard deviation were used when the variables adjusted to the normal distribution; otherwise, the median and interquartile range (first and third quartile) were used. The normality test used was the Shapiro-Wilk.
In the hypothesis contrast of the pre-post values, of the variables with distribution adjusted to normal, the Student´s t statistic was used for paired data; For the variables whose distribution did not conform to normal, the Wilcoxon Test was chosen.
For the contrast of inter-group hypothesis (independent samples with distribution not adjusted to normal), the Mann Whitney test was used.
For the statistical analysis of data, the SPSS program, version 20, was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The experimental study was developed through a randomized controlled clinical trial, with simple random probabilistic sampling. With a pre-post design, the variables measured in the participants before performing the mindfulness training were measured again at the end of the program, eight weeks later, in order to compare the values of both measurements.
| Arm | Type | Receives |
|---|---|---|
| MBSR group | Experimental | Behavioral: Mindfulness-based stress reduction programEnforcement of the standardized program Mindfulness-Based Stress Reduction |
| App group. | Experimental | Behavioral: App REM volver a casaEnforcement of the emotional regulation program based on mindfulness (ERM) through the mobile phone application REM volver a casa |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or greater than 18 years.
- Be a patient of the University Hospital La Paz and have an ICD implanted whose implant was equal to or greater than three months.
- Sufficient knowledge of the Spanish language.
- Have a mobile phone and the ability to handle applications on the phone.
- Availability and sufficient physical conditions to attend mindfulness training in the face-to-face format.
Key exclusion criteria (4 listed)
- Be over 75 years old.
- Be waiting for a heart transplant or other operation related to cardiac pathology.
- Have previous training in mindfulness, unless it had been done before 5 years and had not been practiced since then.
- Being diagnosed with a serious mental disorder and being in an acute symptomatic period of the disease.
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 |
|---|---|---|
| Mindfulness-based stress reduction programMindfulness training through an adaptation of the standardized MBSR program. This program was conducted in person and in a group, with a maximum of 25 participants per group and a total duration of 8 weeks. The training was carried out in 8 sessions, one each week, with a duration of 2 h each session. | Behavioural | MBSR group |
| App REM volver a casaThe intervention was carried out through the computer application for mobile phone "REM volver a casa". This application has been developed to carry out training in the emotional regulation program based on mindfulness, autonomously. The application is designed to carry out the program in 8 weeks. | Behavioural | App group. |
Primary outcome
Health Related Quality of Life
Time frame: In order to assess the change at the Quality of life variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it.
The questionnaire (SF-36: Short Form) uses a Likert scale of 3 or 5 points, with a range of scores from 0 to 100, average of 50 and standard deviation 10.
8 secondary outcomes
Anxiety and Depression
Time frame: In order to assess the change at the anxiety and depression variables, were measured just before starting the mindfulness training program and, eight weeks later, after finishing it.
Anger
Time frame: In order to assess the change at the Anger variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it.
AHR
Time frame: To assess the change in the AHR variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.
NSVT
Time frame: To assess the change in the NSVT variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.
LVEF
Time frame: The value of this parameter is recorded at the beginning of the study.
FC
Time frame: The value of this parameter is recorded at the beginning of the study.
Number of Shocks
Time frame: The estimated period of evaluation is up to 8 years. The events (shocks) accounted are for the period between the date of implantation of the device and the date of the last data collection, approximately 33 months after the start of the study.
Daily Activity
Time frame: To assess the change in the Daily Activity variable, the data collected corresponded to the two months before the intervention and the two months after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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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.
Beatriz Rodríguez Vega, Doctor principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction program and App REM volver a casa in people with Cardiac Arrhythmia and Ventricular Fibrillation, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: In order to assess the change at the Quality of life variable, was measured just before starting the mindfulness training program and, eight weeks later, after finishing it.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2020.