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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634697
• Other study ID #: 2015P000552
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 9, 2017

Study information

• Verified date: February 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This will be measured by a reduction in AF symptom score, perceived stress, anxiety, hostility and depression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 9, 2017
• Est. primary completion date: January 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age: 18-90 years

2. Diagnosed with documented recurrent symptomatic paroxysmal atrial fibrillation

3. Currently on stable medical therapy for AF and willing to continue on the same treatment regimen for 8 weeks while participating in the study.

4. No current or prior practice of yoga, meditation, guided imagery or other techniques that elicit relaxation response (RR).

5. Able to provide informed consent and to understand written and spoken English.

Exclusion Criteria:

1. End Stage renal failure or heart failure, severe unstable medical or psychiatric disease

2. Patients deemed unable to complete protocol due to cognitive or other reasons.

3. 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

Related Conditions & MeSH terms

• Anxiety
• Atrial Fibrillation
• Depression
• Hostility
• Quality of Life
• Stress

Intervention

Behavioral:
• Relaxation Response Resiliency Program
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Benson-Henry Institute for Mind Body Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients with AF	This questionnaire asks AF patients to report their age, gender, race, ethnicity, marital status, highest level of education, and current employment status.	Baseline (week 0)
Primary	AF Symptoms Severity and Burden questionnaire	A 19-item measure assessing the severity, burden, and impact of one's atrial fibrillation symptoms.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Primary	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.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	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.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Buss-Perry Hostility Scale	A 29-item questionnaire that measures a one's levels of aggression.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Cognitive and Affective Mindfulness Scale (CAMS)	Measures the degree to which individuals experience their thoughts and feelings.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Cigna Healthy Eating Scale	A 7-item self-report instrument that measures behavioral eating.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	FACIT-Spirituality	Measures spiritual well-being (sense of meaning in life and the sense of strength in one's faith).	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Generalized Anxiety Disorder 7-item (GAD-7)	A brief measure for assessing generalized anxiety disorder	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	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.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Interpersonal Reactivity Index (IRI)	The IRI assesses the cognitive and affective dimensions of empathy.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Life Orientation Test (LOT) Optimism Scale	The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Medical Outcomes Study (MOS) Social Support Survey	The MOS Social Support Survey measures various dimensions of social support.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Positive and Negative Affect Schedule (PANAS)	The PANAS comprises two mood scales, one that measures positive affect and the other which measures negative affect.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Patient Health Questionnaire (PHQ)	The PHQ measures symptoms of depression and functional impairment.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Lifestyle Questionnaire	Measures physical activity and health behaviors.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Assesses sleep quality and discriminates between good and poor sleepers.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	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.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Penn State Worry Questionnaire (PSWQ)	Measures the trait (or tendency towards) worry in individuals.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	RR Adherence Questionnaire	Assesses the number of days a week where participants practiced RR skills.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	General Self-Efficacy Scale	Measures optimistic self-beliefs to cope with a variety of difficult demands in life.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Fatigue and Distress Analogue Scale	Measures one's distress and fatigue over the past week on a scale from 0 to 10.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Smoking Questionnaire	Measures the prevalence and frequency of an individual's smoking habits.	Change between Baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and 3-month follow up (week 13 or week 26)
Secondary	Medication Use Questionnaire	Patients list their medication name, dosage, and frequency.	Change between Baseline (week 0), post-intervention (week 9), and 3-month follow up (week 13 or week 26)