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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716351
First Posted: October 29, 2012
Last Update Posted: October 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Stefanie Toise, Yale University
  Purpose
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.

Condition Intervention
Cardiac Arrhythmias Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

Resource links provided by NLM:


Further study details as provided by Stefanie Toise, Yale University:

Primary Outcome Measures:
  • Florida Shock Anxiety Scale (FSAS) [ Time Frame: Baseline ]
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.

  • Florida Shock Anxiety Scale (FSAS) [ Time Frame: End of Intervention (8 weeks) ]
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.

  • Self-Compassion Scale [ Time Frame: Baseline ]
    A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.

  • Self-Compassion Scale [ Time Frame: 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 [ Time Frame: Baseline ]
    A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.

  • The number of device-initiated ventricular defibrillations as recorded by their ICD device [ Time Frame: 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 [ Time Frame: Baseline ]
    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.

  • The number of anti-tachycardia pacing events among participants as recorded by their ICD device [ Time Frame: End of Intervention (8 weeks) ]
    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.

  • The number of anti-tachycardia pacing events among participants as recorded by their ICD device [ Time Frame: 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:
  • Expression Manipulation Test [ Time Frame: Baseline ]
    A 31-item list which tests personal and situational cue responsiveness.

  • Expression Manipulation Test [ Time Frame: End of Intervention (8 weeks) ]
    A 31-item list which tests personal and situational cue responsiveness.

  • Pennebaker Inventory [ Time Frame: Baseline ]
    A 54-item list which tests psychological responses to physical symptoms.

  • Pennebaker Inventory [ Time Frame: End of Intervention (8 weeks) ]
    A 54-item list which tests psychological responses to physical symptoms.

  • State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline ]
    A 30-item self report scale emphasizing dispositional states (anxiety).

  • State-Trait Anxiety Inventory (STAI) [ Time Frame: End of Intervention (8 weeks) ]
    A 30-item self report scale emphasizing dispositional states (anxiety).

  • Positive Health Expectation Scale [ Time Frame: Baseline ]
    A 7-item list which measures positive expectations to predict health after heart transplantation.

  • Positive Health Expectation Scale [ Time Frame: End of Intervention (8 weeks) ]
    A 7-item list which measures positive expectations to predict health after heart transplantation.

  • Florida Patient Acceptance Survey (FPAS) [ Time Frame: Baseline ]
    An 18-item list which measures patient acceptance of implantable cardiac device therapy.

  • Florida Patient Acceptance Survey (FPAS) [ Time Frame: 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) [ Time Frame: Baseline ]
    A 20-item list which is a self-report depression scale for research in the general population.

  • Center for Epidemiologic Study Depression Scale (CES-D) [ Time Frame: 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 [ Time Frame: Baseline ]
    A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.

  • Interpersonal Support Evaluation [ Time Frame: 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 [ Time Frame: Baseline ]
    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  • Hospitalizations [ Time Frame: End of Intervention (8 weeks) ]
    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  • Hospitalizations [ Time Frame: Six month follow-up ]
    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  • Implantation Status [ Time Frame: Baseline ]
    Primary prevention and secondary prevention data from Medical Chart Review.

  • Medications [ Time Frame: Baseline ]
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  • Medications [ Time Frame: End of Intervention (8 weeks) ]
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  • Medications [ Time Frame: Six month follow-up ]
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  • Co-morbidities [ Time Frame: Baseline ]
    Medical chart review for co-existing morbidities.

  • Co-morbidities [ Time Frame: End of Intervention (8 weeks) ]
    Medical chart review for co-existing morbidities.

  • Co-morbidities [ Time Frame: Six month follow-up ]
    Medical chart review for co-existing morbidities.

  • Ejection Fraction [ Time Frame: Baseline ]
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  • Ejection Fraction [ Time Frame: End of Intervention (8 weeks) ]
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  • Ejection Fraction [ Time Frame: Six month follow-up ]
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  • Atrial Fibrillation [ Time Frame: Baseline ]
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.

  • Atrial Fibrillation [ Time Frame: End of Intervention (8 weeks) ]
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.

  • Atrial Fibrillation [ Time Frame: Six month follow up ]
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.


Enrollment: 55
Study Start Date: August 2007
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716351


Sponsors and Collaborators
Yale University
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
  More Information

Responsible Party: Stefanie Toise, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01716351     History of Changes
Other Study ID Numbers: #SR-1569
F31AT003757 ( U.S. NIH Grant/Contract )
First Submitted: October 17, 2012
First Posted: October 29, 2012
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by Stefanie Toise, Yale University:
Randomized Clinical Control Trial
Complementary and Alternative Medicine
Yoga
Electrophysiology
Implantable Cardioverter Defibrillator
Psychosocial
Anxiety
Self-Compassion
Anti-Tachycardia Pacing Events

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes