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

Not Applicable

Completed

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT01716351
• Lead Sponsor: Yale University

Brief Summary

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.

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 Timeline

• Study Start: 2007-08
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Status Verified: 2012-10
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-24
• Last Update Submitted: 2012-10-24
• Study First Posted: 2012-10-29
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Florida Shock Anxiety Scale (FSAS)	End of Intervention (8 weeks)	A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
Self-Compassion Scale	End of Intervention (8 weeks)	A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
The number of device-initiated ventricular defibrillations as recorded by their ICD device	Six month follow-up	A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.
The number of anti-tachycardia pacing events among participants as recorded by their ICD device	Six month follow-up	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.

Secondary Outcome Measures

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