Atrial FibrillationNCT02634697
Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
A study testing Relaxation Response Resiliency Program in people with Atrial Fibrillation and Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if an eight week multimodal Relaxation Response Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and quality of life (Q.O.L) in atrial fibrillation (AF) patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Stress, Quality of Life
- What is being tested?
- Relaxation Response Resiliency Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 9 Jan 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-90 years
- Diagnosed with documented recurrent symptomatic paroxysmal atrial fibrillation
- Currently on stable medical therapy for AF and willing to continue on the same treatment regimen for 8 weeks while participating in the study.
- No current or prior practice of yoga, meditation, guided imagery or other techniques that elicit relaxation response (RR).
- Able to provide informed consent and to understand written and spoken English.
Who cannot join
- End Stage renal failure or heart failure, severe unstable medical or psychiatric disease
- Patients deemed unable to complete protocol due to cognitive or other reasons.
- Patients on psychoactive medications will have eligibility determined by the PI or MD co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine if an eight week multimodal Relaxation Response Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a reduction in AF symptom score, perceived stress, anxiety, hostility and depression.
Read the detailed description
Atrial fibrillation (AF) is a very common cardiovascular disease. Symptoms include dizziness, palpitations, lightheadedness, shortness of breath, fatigue and exercise intolerance. AF is also associated with a high risk of complications like thrombo-embolism and stroke, heart failure, dementia. The presence and severity of these symptoms and complications adversely affect a patient's health related quality of life. Improvement in quality of life (QOL) is an important measure for evaluating response to treatment in AF patients. Depression and anxiety are significant part of the psychosocial burden faced by approximately one-third of AF patients, and are important components that effect QOL in these patients. In this study the investigators will apply the 3RP (Relaxation Response Resiliency Program - developed at the Benson Henry Institute at Massachusetts General Hospital) intervention among AF patients to assess the reduction in their stress, anxiety and depression levels and the reduction in AF symptom burden and severity.
- Conditions
- Atrial Fibrillation, Stress, Quality of Life, Anxiety, Depression, Hostility
- Being tested
- Relaxation Response Resiliency Program
- Keywords
- Atrial Fibrillation, Relaxation Response Resiliency Program Intervention, AF Symptom Severity and Burden, Stress, Anxiety, Depression and Hostility, Quality of Life, AF, QOL, 3RP
- Medical subject headings
- Atrial Fibrillation, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response Resiliency ProgramBehavioural
Also called 3RP
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga
| Study group | Role | What they receive |
|---|---|---|
| 3RP Intervention Group | Experimental | AF Patients will undergo the 3RP intervention which will comprise of the following:
i. One-one-one session: each subject will spend an hour with a clinician to set specific goals for the intervention. They will also answer questionnaires.
ii. ECG monitoring: Enrolled subjects may be monitored with an ECG at some point after the time of consent up to the day of the one-on-one session, and again after completing the 8 weeks.
iii. Weeks 1 - 8: subjects will meet with the clinician/staff member as a group once a week for 1.5 hours each where they will be taught a variety of techniques to elicit the relaxation response as well as other cognitive skills.
At the end of the 4th (mid-point) and 8th (last) weekly session, subjects will answer questionnaires.
iv. 6 month follow up: 3 months after the final 3RP session to answer questionnaires.
v. Subjects will be asked to keep track of their AF episodes during the course of the study. Receives: Behavioral: Relaxation Response Resiliency Program |
| 3RP Waitlist Control Group | Active comparator | The Control Group will wait for 6 months (from the time the Intervention group starts the 3RP intervention) and then will undergo the same study procedures as the intervention group - except for the 6 month follow up. Receives: Behavioral: Relaxation Response Resiliency Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF Symptoms Severity and Burden questionnaire
A 19-item measure assessing the severity, burden, and impact of one's atrial fibrillation symptoms.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Measure of Current Status (MOCS-A)
The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary outcomes (21)
Visual Analog Stress Scale
Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 10.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Buss-Perry Hostility Scale
A 29-item questionnaire that measures a one's levels of aggression.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Cognitive and Affective Mindfulness Scale (CAMS)
Measures the degree to which individuals experience their thoughts and feelings.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Cigna Healthy Eating Scale
A 7-item self-report instrument that measures behavioral eating.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
FACIT-Spirituality
Measures spiritual well-being (sense of meaning in life and the sense of strength in one's faith).
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Generalized Anxiety Disorder 7-item (GAD-7)
A brief measure for assessing generalized anxiety disorder
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
The Gratitude Questionnaire (GQ-6)
The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Interpersonal Reactivity Index (IRI)
The IRI assesses the cognitive and affective dimensions of empathy.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Life Orientation Test (LOT) Optimism Scale
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Medical Outcomes Study (MOS) Social Support Survey
The MOS Social Support Survey measures various dimensions of social support.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Positive and Negative Affect Schedule (PANAS)
The PANAS comprises two mood scales, one that measures positive affect and the other which measures negative affect.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Patient Health Questionnaire (PHQ)
The PHQ measures symptoms of depression and functional impairment.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Lifestyle Questionnaire
Measures physical activity and health behaviors.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Pittsburgh Sleep Quality Index (PSQI)
Assesses sleep quality and discriminates between good and poor sleepers.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Perceived Stress Scale (PSS-10)
The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Penn State Worry Questionnaire (PSWQ)
Measures the trait (or tendency towards) worry in individuals.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
RR Adherence Questionnaire
Assesses the number of days a week where participants practiced RR skills.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
General Self-Efficacy Scale
Measures optimistic self-beliefs to cope with a variety of difficult demands in life.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Fatigue and Distress Analogue Scale
Measures one's distress and fatigue over the past week on a scale from 0 to 10.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Smoking Questionnaire
Measures the prevalence and frequency of an individual's smoking habits.
Measured: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Medication Use Questionnaire
Patients list their medication name, dosage, and frequency.
Measured: Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startApr 2015
- Primary completion9 Jan 2017
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Benson-Henry Institute for Mind Body Medicine
- Responsible party
- Principal investigator, Jeremy n. Ruskin, MD, Massachusetts General Hospital
- Investigators
- Jeremy N Ruskin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634697
- Sponsor's protocol ID
- 2015P000552
- Status last verified
- Feb 2020
- First submitted
- 10 Dec 2015
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02634697
- Acronym / sponsor ID
- 2015P000552
- Conditions
- Atrial Fibrillation, Stress, Quality of Life, Anxiety, Depression, Hostility
- Keywords
- Atrial Fibrillation, Relaxation Response Resiliency Program Intervention, AF Symptom Severity and Burden, Stress, Anxiety, Depression and Hostility, Quality of Life, AF, QOL, 3RP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Benson-Henry Institute for Mind Body Medicine
- Study start
- Apr 2015
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 18 Dec 2015 (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.
The purpose of this study is to determine if an eight week multimodal Relaxation Response Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a reduction in AF symptom score, perceived stress, anxiety, hostility and depression.
Detailed description
Atrial fibrillation (AF) is a very common cardiovascular disease. Symptoms include dizziness, palpitations, lightheadedness, shortness of breath, fatigue and exercise intolerance. AF is also associated with a high risk of complications like thrombo-embolism and stroke, heart failure, dementia. The presence and severity of these symptoms and complications adversely affect a patient's health related quality of life. Improvement in quality of life (QOL) is an important measure for evaluating response to treatment in AF patients. Depression and anxiety are significant part of the psychosocial burden faced by approximately one-third of AF patients, and are important components that effect QOL in these patients. In this study the investigators will apply the 3RP (Relaxation Response Resiliency Program - developed at the Benson Henry Institute at Massachusetts General Hospital) intervention among AF patients to assess the reduction in their stress, anxiety and depression levels and the reduction in AF symptom burden and severity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3RP Intervention Group | Experimental | Behavioral: Relaxation Response Resiliency ProgramAF Patients will undergo the 3RP intervention which will comprise of the following: i. One-one-one session: each subject will spend an hour with a clinician to set specific goals for the intervention. They will also answer questionnaires. ii. ECG monitoring: Enrolled subjects may be monitored with an ECG at some point after the time of consent up to the day of the one-on-one session, and again after completing the 8 weeks. iii. Weeks 1 - 8: subjects will meet with the clinician/staff member as a group once a week for 1.5 hours each where they will be taught a variety of techniques to elicit the relaxation response as well as other cognitive skills. At the end of the 4th (mid-point) and 8th (last) weekly session, subjects will answer questionnaires. iv. 6 month follow up: 3 months after the final 3RP session to answer questionnaires. v. Subjects will be asked to keep track of their AF episodes during the course of the study. |
| 3RP Waitlist Control Group | Active comparator | Behavioral: Relaxation Response Resiliency ProgramThe Control Group will wait for 6 months (from the time the Intervention group starts the 3RP intervention) and then will undergo the same study procedures as the intervention group - except for the 6 month follow up. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-90 years
- Diagnosed with documented recurrent symptomatic paroxysmal atrial fibrillation
- Currently on stable medical therapy for AF and willing to continue on the same treatment regimen for 8 weeks while participating in the study.
- No current or prior practice of yoga, meditation, guided imagery or other techniques that elicit relaxation response (RR).
- Able to provide informed consent and to understand written and spoken English.
Key exclusion criteria (3 listed)
- End Stage renal failure or heart failure, severe unstable medical or psychiatric disease
- Patients deemed unable to complete protocol due to cognitive or other reasons.
- Patients on psychoactive medications will have eligibility determined by the PI or MD co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable
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 |
|---|---|---|
| Relaxation Response Resiliency ProgramAlso: 3RP8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga | Behavioural | 3RP Intervention Group, 3RP Waitlist Control Group |
Primary outcome
AF Symptoms Severity and Burden questionnaire
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
A 19-item measure assessing the severity, burden, and impact of one's atrial fibrillation symptoms.
Measure of Current Status (MOCS-A)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
21 secondary outcomes
Visual Analog Stress Scale
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Buss-Perry Hostility Scale
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Cognitive and Affective Mindfulness Scale (CAMS)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Cigna Healthy Eating Scale
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
FACIT-Spirituality
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
The Gratitude Questionnaire (GQ-6)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Interpersonal Reactivity Index (IRI)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Life Orientation Test (LOT) Optimism Scale
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Medical Outcomes Study (MOS) Social Support Survey
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Positive and Negative Affect Schedule (PANAS)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Patient Health Questionnaire (PHQ)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Lifestyle Questionnaire
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Perceived Stress Scale (PSS-10)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Penn State Worry Questionnaire (PSWQ)
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
RR Adherence Questionnaire
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
General Self-Efficacy Scale
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Fatigue and Distress Analogue Scale
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Smoking Questionnaire
Time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Medication Use Questionnaire
Time frame: Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
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 28 Feb 2020.
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Atrial Fibrillation (AF)
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.
Jeremy N Ruskin, MD principal investigator
Massachusetts General 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 Relaxation Response Resiliency Program in people with Atrial Fibrillation and Stress, run by Massachusetts General Hospital 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 5 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: finished, as of the sponsor's last update on 28 Feb 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 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?
AF Symptoms Severity and Burden questionnaire (time frame: Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)). The study lists 2 primary outcomes in all. 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 28 Feb 2020.