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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga
Massachusetts General Hospital
Boston, Massachusetts, United States
AF Symptoms Severity and Burden questionnaire
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)
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.
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)
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.
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
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)
Cognitive and Affective Mindfulness Scale (CAMS)
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)
Cigna Healthy Eating Scale
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)
FACIT-Spirituality
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)
Generalized Anxiety Disorder 7-item (GAD-7)
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)
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.
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)
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)
Life Orientation Test (LOT) Optimism Scale
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)
Medical Outcomes Study (MOS) Social Support Survey
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)
Positive and Negative Affect Schedule (PANAS)
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)
Patient Health Questionnaire (PHQ)
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)
Lifestyle Questionnaire
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)
Pittsburgh Sleep Quality Index (PSQI)
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)
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.
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)
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)
RR Adherence Questionnaire
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)
General Self-Efficacy Scale
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)
Fatigue and Distress Analogue Scale
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)
Smoking Questionnaire
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)
Medication Use Questionnaire
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)
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