The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

Psychosocial risks are significant in the management of patients with cardiovascular disease and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled, clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of life in ICD patients. The specialized, real-time data, collected by the device provides a unique look at the electrophysiological parameters of each patient's heart.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmias
• Intervention / Treatment: Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients

Detailed Description

All intervention data will be analyzed to determine the statistical significance of the data, and to accept or reject the hypothesis. In addition, the researcher will conduct supplemental interviews with patients who have lived with the implantable cardioverter defibrillator (ICD) device for at least six months and who are not in the intervention. The qualitative data gathered from these interviews will document concepts of illness and healing and general beliefs about mind-body interventions.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
• Must be 18 or more years of age

Exclusion Criteria:

• Patients requiring more than 48 hours of hospitalization for implantation
• Mental Incompetence (Dementia)
• Physician's contra-indication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Adapted Yoga Intervention Group; Patients received the Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients and a call from a cardiac research nurse once monthly for five months.	Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients; A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
NO_INTERVENTION: Control; Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Florida Shock Anxiety Scale (FSAS)	A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.	Baseline
Florida Shock Anxiety Scale (FSAS)	A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.	End of Intervention (8 weeks)
Self-Compassion Scale	A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.	Baseline
Self-Compassion Scale	A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.	End of Intervention (8 weeks)
The number of device-initiated ventricular defibrillations as recorded by their ICD device	A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.	Baseline
The number of device-initiated ventricular defibrillations as recorded by their ICD device	A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.	Six month follow-up
The number of anti-tachycardia pacing events among participants as recorded by their ICD device	As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.	Baseline
The number of anti-tachycardia pacing events among participants as recorded by their ICD device	As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.	End of Intervention (8 weeks)
The number of anti-tachycardia pacing events among participants as recorded by their ICD device	As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.	Six month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression Manipulation Test	A 31-item list which tests personal and situational cue responsiveness.	Baseline
Expression Manipulation Test	A 31-item list which tests personal and situational cue responsiveness.	End of Intervention (8 weeks)
Pennebaker Inventory	A 54-item list which tests psychological responses to physical symptoms.	Baseline
Pennebaker Inventory	A 54-item list which tests psychological responses to physical symptoms.	End of Intervention (8 weeks)
State-Trait Anxiety Inventory (STAI)	A 30-item self report scale emphasizing dispositional states (anxiety).	Baseline
State-Trait Anxiety Inventory (STAI)	A 30-item self report scale emphasizing dispositional states (anxiety).	End of Intervention (8 weeks)
Positive Health Expectation Scale	A 7-item list which measures positive expectations to predict health after heart transplantation.	Baseline
Positive Health Expectation Scale	A 7-item list which measures positive expectations to predict health after heart transplantation.	End of Intervention (8 weeks)
Florida Patient Acceptance Survey (FPAS)	An 18-item list which measures patient acceptance of implantable cardiac device therapy.	Baseline
Florida Patient Acceptance Survey (FPAS)	An 18-item list which measures patient acceptance of implantable cardiac device therapy.	End of Intervention (8 weeks)
Center for Epidemiologic Study Depression Scale (CES-D)	A 20-item list which is a self-report depression scale for research in the general population.	Baseline
Center for Epidemiologic Study Depression Scale (CES-D)	A 20-item list which is a self-report depression scale for research in the general population.	End of Intervention (8 weeks)
Interpersonal Support Evaluation	A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.	Baseline
Interpersonal Support Evaluation	A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.	End of Intervention (8 weeks)
Hospitalizations	Medical Chart Review of cardiac and non-cardiac hospitalizations.	Baseline
Hospitalizations	Medical Chart Review of cardiac and non-cardiac hospitalizations.	End of Intervention (8 weeks)
Hospitalizations	Medical Chart Review of cardiac and non-cardiac hospitalizations.	Six month follow-up
Implantation Status	Primary prevention and secondary prevention data from Medical Chart Review.	Baseline
Medications	Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.	Baseline
Medications	Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.	End of Intervention (8 weeks)
Medications	Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.	Six month follow-up
Co-morbidities	Medical chart review for co-existing morbidities.	Baseline
Co-morbidities	Medical chart review for co-existing morbidities.	End of Intervention (8 weeks)
Co-morbidities	Medical chart review for co-existing morbidities.	Six month follow-up
Ejection Fraction	Cardiac ejection fraction measured from Electro-cardiogram (EKG).	Baseline
Ejection Fraction	Cardiac ejection fraction measured from Electro-cardiogram (EKG).	End of Intervention (8 weeks)
Ejection Fraction	Cardiac ejection fraction measured from Electro-cardiogram (EKG).	Six month follow-up
Atrial Fibrillation	A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.	Baseline
Atrial Fibrillation	A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.	End of Intervention (8 weeks)
Atrial Fibrillation	A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.	Six month follow up

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Stefanie CF Toise, PhD, MPH, Yale New Haven Hospital, St. Raphael Campus; Study Director: Thomas J Donohue, MD, Yale New Haven Hospital, St. Raphael Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (ESTIMATE): October 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Anxiety; Yoga; Complementary and Alternative Medicine; Self-Compassion; Electrophysiology; Psychosocial; Implantable Cardioverter Defibrillator; Randomized Clinical Control Trial; Anti-Tachycardia Pacing Events
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: #SR-1569; F31AT003757 (NIH)