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Completed

NCT Number: NCT02634697

Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Anxiety Anxiety Disorders Arrhythmias, Cardiac Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases Hostility Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Stress

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation Response Resiliency Program

Behavioral

8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga

Other names: 3RP

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 10.

  2. 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)

    A 29-item questionnaire that measures a one's levels of aggression.

  3. 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)

    Measures the degree to which individuals experience their thoughts and feelings.

  4. 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)

    A 7-item self-report instrument that measures behavioral eating.

  5. 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)

    Measures spiritual well-being (sense of meaning in life and the sense of strength in one's faith).

  6. 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)

    A brief measure for assessing generalized anxiety disorder

  7. 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)

    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.

  8. 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)

    The IRI assesses the cognitive and affective dimensions of empathy.

  9. 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)

    The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.

  10. 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)

    The MOS Social Support Survey measures various dimensions of social support.

  11. 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)

    The PANAS comprises two mood scales, one that measures positive affect and the other which measures negative affect.

  12. 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)

    The PHQ measures symptoms of depression and functional impairment.

  13. 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)

    Measures physical activity and health behaviors.

  14. 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)

    Assesses sleep quality and discriminates between good and poor sleepers.

  15. 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)

    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.

  16. 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)

    Measures the trait (or tendency towards) worry in individuals.

  17. 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)

    Assesses the number of days a week where participants practiced RR skills.

  18. 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)

    Measures optimistic self-beliefs to cope with a variety of difficult demands in life.

  19. 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)

    Measures one's distress and fatigue over the past week on a scale from 0 to 10.

  20. 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)

    Measures the prevalence and frequency of an individual's smoking habits.

  21. Medication Use Questionnaire

    Time frame: Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26)

    Patients list their medication name, dosage, and frequency.

Other outcomes

  1. Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients with AF

    Time frame: Baseline (week 0)

    This questionnaire asks AF patients to report their age, gender, race, ethnicity, marital status, highest level of education, and current employment status.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Benson-Henry Institute for Mind Body Medicine

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2015
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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