Back to resultsImpact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Stress, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Response Resiliency Program
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Relaxation Response Resiliency Program Intervention, AF Symptom Severity and Burden, Stress, Anxiety, Depression and Hostility, Quality of Life, AF, QOL, 3RP
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3RP Intervention Group
3RP Waitlist Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
AF Symptoms Severity and Burden questionnaire
A 19-item measure assessing the severity, burden, and impact of one's atrial fibrillation symptoms.
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.
Secondary Outcome Measures
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.
Buss-Perry Hostility Scale
A 29-item questionnaire that measures a one's levels of aggression.
Cognitive and Affective Mindfulness Scale (CAMS)
Measures the degree to which individuals experience their thoughts and feelings.
Cigna Healthy Eating Scale
A 7-item self-report instrument that measures behavioral eating.
FACIT-Spirituality
Measures spiritual well-being (sense of meaning in life and the sense of strength in one's faith).
Generalized Anxiety Disorder 7-item (GAD-7)
A brief measure for assessing generalized anxiety disorder
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.
Interpersonal Reactivity Index (IRI)
The IRI assesses the cognitive and affective dimensions of empathy.
Life Orientation Test (LOT) Optimism Scale
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Medical Outcomes Study (MOS) Social Support Survey
The MOS Social Support Survey measures various dimensions of social support.
Positive and Negative Affect Schedule (PANAS)
The PANAS comprises two mood scales, one that measures positive affect and the other which measures negative affect.
Patient Health Questionnaire (PHQ)
The PHQ measures symptoms of depression and functional impairment.
Lifestyle Questionnaire
Measures physical activity and health behaviors.
Pittsburgh Sleep Quality Index (PSQI)
Assesses sleep quality and discriminates between good and poor sleepers.
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.
Penn State Worry Questionnaire (PSWQ)
Measures the trait (or tendency towards) worry in individuals.
RR Adherence Questionnaire
Assesses the number of days a week where participants practiced RR skills.
General Self-Efficacy Scale
Measures optimistic self-beliefs to cope with a variety of difficult demands in life.
Fatigue and Distress Analogue Scale
Measures one's distress and fatigue over the past week on a scale from 0 to 10.
Smoking Questionnaire
Measures the prevalence and frequency of an individual's smoking habits.
Medication Use Questionnaire
Patients list their medication name, dosage, and frequency.
Full Information
NCT ID
NCT02634697
First Posted
December 10, 2015
Last Updated
February 26, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Benson-Henry Institute for Mind Body Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02634697
Brief Title
Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
Official Title
Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 9, 2017 (Actual)
Study Completion Date
January 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Benson-Henry Institute for Mind Body Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3RP Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
3RP Waitlist Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response Resiliency Program
Other Intervention Name(s)
3RP
Intervention Description
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga
Primary Outcome Measure Information:
Title
AF Symptoms Severity and Burden questionnaire
Description
A 19-item measure assessing the severity, burden, and impact of one's atrial fibrillation symptoms.
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)
Title
Measure of Current Status (MOCS-A)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Visual Analog Stress Scale
Description
Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 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)
Title
Buss-Perry Hostility Scale
Description
A 29-item questionnaire that measures a one's levels of aggression.
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)
Title
Cognitive and Affective Mindfulness Scale (CAMS)
Description
Measures the degree to which individuals experience their thoughts and feelings.
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)
Title
Cigna Healthy Eating Scale
Description
A 7-item self-report instrument that measures behavioral eating.
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)
Title
FACIT-Spirituality
Description
Measures spiritual well-being (sense of meaning in life and the sense of strength in one's faith).
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)
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
A brief measure for assessing generalized anxiety disorder
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)
Title
The Gratitude Questionnaire (GQ-6)
Description
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.
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)
Title
Interpersonal Reactivity Index (IRI)
Description
The IRI assesses the cognitive and affective dimensions of empathy.
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)
Title
Life Orientation Test (LOT) Optimism Scale
Description
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
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)
Title
Medical Outcomes Study (MOS) Social Support Survey
Description
The MOS Social Support Survey measures various dimensions of social support.
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)
Title
Positive and Negative Affect Schedule (PANAS)
Description
The PANAS comprises two mood scales, one that measures positive affect and the other which measures negative affect.
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)
Title
Patient Health Questionnaire (PHQ)
Description
The PHQ measures symptoms of depression and functional impairment.
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)
Title
Lifestyle Questionnaire
Description
Measures physical activity and health behaviors.
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)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Assesses sleep quality and discriminates between good and poor sleepers.
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)
Title
Perceived Stress Scale (PSS-10)
Description
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.
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)
Title
Penn State Worry Questionnaire (PSWQ)
Description
Measures the trait (or tendency towards) worry in individuals.
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)
Title
RR Adherence Questionnaire
Description
Assesses the number of days a week where participants practiced RR skills.
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)
Title
General Self-Efficacy Scale
Description
Measures optimistic self-beliefs to cope with a variety of difficult demands in life.
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)
Title
Fatigue and Distress Analogue Scale
Description
Measures one's distress and fatigue over the past week on a scale from 0 to 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)
Title
Smoking Questionnaire
Description
Measures the prevalence and frequency of an individual's smoking habits.
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)
Title
Medication Use Questionnaire
Description
Patients list their medication name, dosage, and frequency.
Time Frame
Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Other Pre-specified Outcome Measures:
Title
Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients with AF
Description
This questionnaire asks AF patients to report their age, gender, race, ethnicity, marital status, highest level of education, and current employment status.
Time Frame
Baseline (week 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy N Ruskin, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation
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