Arrhythmias, CardiacRISTANCT00627263
Stress Reduction to Reduce Risk for Arrhythmia in ICD Patients (The RISTA Study)
A study testing Stress reduction treatment (SRT) program in people with Arrhythmias, Cardiac, run by Yale University at 1 site in United States.
Trial summary
An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms. Arrhythmias can be caused by many factors, including stress and anger. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Stress reduction treatment (SRT) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving an ICD or currently have an ICD and have recieved appropriated ICD shock therapy in the 6 months before study entry
- Ischemic cardiomyopathy or non-ischemic (dilated) cardiomyopathy
- Fluent in spoken and written English
- Able to participate in the SRT program
Who cannot join
- Unable to comply with the study or participate in SRT treatment, if assigned
- Incapacitating illness (e.g., stage IV congestive heart failure) that would interfere with study participation
- Life expectancy of less than 2 years (e.g., due to metastatic cancer)
- Uncommon etiologies of arrhythmia (e.g., long QT syndrome, hypertrophic cardiomyopathy, Brugada syndrome)
- Cognitive impairment, based on Mini-Mental Status Exam (MMSE) and educational level. If education level is less than 8th grade, then people with an MMSE score of less than 17 will not be enrolled; if education level is greater than 8th grade, then people with an MMSE score of less than 24 will not be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Medical School
New Haven, Connecticut, 06520
About this study
Official title: Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias
An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms. Arrhythmias can be caused by many factors, including stress and anger. This study will evaluate the use of a stress reduction treatment (SRT) program aimed at reducing the occurrence of arrhythmias that require treatment with an ICD shock.
Read the detailed description
An ICD is a device designed to quickly detect a life-threatening, rapid heartbeat. Through a process called defibrillation, the ICD tries to convert an abnormal heart rhythm back to normal by delivering an electrical shock to the heart. The ICD continuously monitors heartbeats to ensure that they are normal, and it only delivers a shock to the heart when it senses a life-threatening arrhythmia. Because of the recent funding approval by Medicaid, it is now estimated that more than 500,000 people will receive ICDs annually. Although ICDs are life-saving medical devices, some people may experience anxiety, depression, and impaired quality of life as a result of the repeated ICD shocks. Additionally, increased mental and emotional stress and anger may increase the likelihood of experiencing more arrhythmias requiring an ICD shock. SRT programs that encourage people to manage their emotions may decrease the frequency of arrhythmias. Furthermore, SRT programs have been shown to be successful at reducing other stress-related heart conditions. The purpose of this study is to evaluate the effectiveness of an SRT program at reducing the incidence of ICD shock-treated arrhythmias among people with newly implanted ICDs.
This study will enroll people who have recently received an ICD. Initially, participants will complete questionnaires about mood and attitudes. Next, at a baseline study visit, participants will complete a mental stress exercise in which they will perform math problems and describe an experience that made them angry. During this exercise, participants will undergo blood pressure measurements, blood collection, and an electrocardiogram (EKG) to measure electrical activity of the heart. Participants will also wear a monitor for 24 hours after the study visit to record heart activity. Participants will then be randomly assigned to either take part in the SRT group and receive usual care or only receive usual care. For 10 weeks, participants in the SRT group will attend 8 group sessions that will focus on learning and applying stress reduction techniques to everyday living. All participants will attend a 3-month follow-up visit for repeat baseline testing. At Months 6, 12, and 24, participants will complete questionnaires during routine doctor's visits or by mail.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Stress reduction treatment (SRT) program
- Keywords
- ICD, Cardiac Arrhythmia, Arrhythmia, Stress, Anger
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress reduction treatment (SRT) programBehavioural
The SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Participants will receive the usual cardiologic care for ICD patients provided by their medical team. |
| 2 | Experimental | In addition to the usual cardiologic care for ICD patients provided by the participants medical team, those randomized to Intervention will receive the stress reduction treatment (SRT) program (see below). Receives: Behavioral: Stress reduction treatment (SRT) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICD shock-treated ventricular arrhythmia event-free survival
The occurrence of ICD shock treated ventricular arrhythmia
Measured: Measured at Month 24
Secondary outcomes (3)
Laboratory stress-provoked arrhythmogenic changes in the heart rhythm
Arrhythmogenic changes in the heart rhythm during laboratory mental stress
Measured: Measured at Baseline and Month 6
24-hour heart rate variability
Heart rate variability on 24 hour holter monitoring
Measured: Measured at Baseline and Month 6
Quality of life
SF-36 assessment
Measured: Measured at Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Matthew M. Burg, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627263
- Sponsor's protocol ID
- 0708003000
- Other IDs
- R01HL084438
- Acronym
- RISTA
- Status last verified
- Jan 2018
- First submitted
- 28 Feb 2008
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Donahue RG, Lampert R, Dornelas E, Clemow L, Burg MM; RISTA Investigators. Rationale and design of a randomized clinical trial comparing stress reduction treatment to usual cardiac care: the Reducing Vulnerability to Implantable Cardioverter Defibrillator Shock-Treated Ventricular Arrhythmias (RISTA) trial. Psychosom Med. 2010 Feb;72(2):172-7. doi: 10.1097/PSY.0b013e3181c932d4. Epub 2009 Dec 22.
PubMed 20028832
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT00627263
- Acronym / sponsor ID
- RISTA / 0708003000
- Conditions
- Arrhythmias, Cardiac
- Keywords
- ICD, Cardiac Arrhythmia, Arrhythmia, Stress, Anger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Mar 2008 (estimated)
- 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.
An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms. Arrhythmias can be caused by many factors, including stress and anger. This study will evaluate the use of a stress reduction treatment (SRT) program aimed at reducing the occurrence of arrhythmias that require treatment with an ICD shock.
Detailed description
An ICD is a device designed to quickly detect a life-threatening, rapid heartbeat. Through a process called defibrillation, the ICD tries to convert an abnormal heart rhythm back to normal by delivering an electrical shock to the heart. The ICD continuously monitors heartbeats to ensure that they are normal, and it only delivers a shock to the heart when it senses a life-threatening arrhythmia. Because of the recent funding approval by Medicaid, it is now estimated that more than 500,000 people will receive ICDs annually. Although ICDs are life-saving medical devices, some people may experience anxiety, depression, and impaired quality of life as a result of the repeated ICD shocks. Additionally, increased mental and emotional stress and anger may increase the likelihood of experiencing more arrhythmias requiring an ICD shock. SRT programs that encourage people to manage their emotions may decrease the frequency of arrhythmias. Furthermore, SRT programs have been shown to be successful at reducing other stress-related heart conditions. The purpose of this study is to evaluate the effectiveness of an SRT program at reducing the incidence of ICD shock-treated arrhythmias among people with newly implanted ICDs.
This study will enroll people who have recently received an ICD. Initially, participants will complete questionnaires about mood and attitudes. Next, at a baseline study visit, participants will complete a mental stress exercise in which they will perform math problems and describe an experience that made them angry. During this exercise, participants will undergo blood pressure measurements, blood collection, and an electrocardiogram (EKG) to measure electrical activity of the heart. Participants will also wear a monitor for 24 hours after the study visit to record heart activity. Participants will then be randomly assigned to either take part in the SRT group and receive usual care or only receive usual care. For 10 weeks, participants in the SRT group will attend 8 group sessions that will focus on learning and applying stress reduction techniques to everyday living. All participants will attend a 3-month follow-up visit for repeat baseline testing. At Months 6, 12, and 24, participants will complete questionnaires during routine doctor's visits or by mail.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Participants will receive the usual cardiologic care for ICD patients provided by their medical team. |
| 2 | Experimental | Behavioral: Stress reduction treatment (SRT) programIn addition to the usual cardiologic care for ICD patients provided by the participants medical team, those randomized to Intervention will receive the stress reduction treatment (SRT) program (see below). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving an ICD or currently have an ICD and have recieved appropriated ICD shock therapy in the 6 months before study entry
- Ischemic cardiomyopathy or non-ischemic (dilated) cardiomyopathy
- Fluent in spoken and written English
- Able to participate in the SRT program
Key exclusion criteria (5 listed)
- Unable to comply with the study or participate in SRT treatment, if assigned
- Incapacitating illness (e.g., stage IV congestive heart failure) that would interfere with study participation
- Life expectancy of less than 2 years (e.g., due to metastatic cancer)
- Uncommon etiologies of arrhythmia (e.g., long QT syndrome, hypertrophic cardiomyopathy, Brugada syndrome)
- Cognitive impairment, based on Mini-Mental Status Exam (MMSE) and educational level. If education level is less than 8th grade, then people with an MMSE score of less than 17 will not be enrolled; if education level is greater than 8th grade, then people with an MMSE score of less than 24 will not be enrolled.
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 |
|---|---|---|
| Stress reduction treatment (SRT) programThe SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks. | Behavioural | 2 |
Primary outcome
ICD shock-treated ventricular arrhythmia event-free survival
Time frame: Measured at Month 24
The occurrence of ICD shock treated ventricular arrhythmia
3 secondary outcomes
Laboratory stress-provoked arrhythmogenic changes in the heart rhythm
Time frame: Measured at Baseline and Month 6
24-hour heart rate variability
Time frame: Measured at Baseline and Month 6
Quality of life
Time frame: Measured at Month 24
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 17 Jan 2018.
- Derived from this study: PubMed 20028832Donahue RG, Lampert R, Dornelas E, Clemow L, Burg MM; RISTA Investigators. Rationale and design of a randomized clinical trial comparing stress reduction treatment to usual cardiac care: the Reducing Vulnerability to Implantable Cardioverter Defibrillator Shock-Treated Ventricular Arrhythmias (RISTA) trial. Psychosom Med. 2010 Feb;72(2):172-7. doi: 10.1097/PSY.0b013e3181c932d4. Epub 2009 Dec 22.
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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.
Matthew M. Burg, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress reduction treatment (SRT) program in people with Arrhythmias, Cardiac, run by Yale University at 1 site in United States.
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 5 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 17 Jan 2018. 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 United States. 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?
ICD shock-treated ventricular arrhythmia event-free survival (time frame: Measured at Month 24). 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 NCT00627263, which also lists 1 linked publication.
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 Jan 2018.