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Completed

NCT Number: NCT01716351

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.

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Key information

Conditions

Cardiac Arrhythmias Anxiety Disorders Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients

Behavioral

A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.

Primary outcomes

  1. Florida Shock Anxiety Scale (FSAS)

    Time frame: Baseline

    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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 outcomes

  1. Expression Manipulation Test

    Time frame: Baseline

    A 31-item list which tests personal and situational cue responsiveness.

  2. Expression Manipulation Test

    Time frame: End of Intervention (8 weeks)

    A 31-item list which tests personal and situational cue responsiveness.

  3. Pennebaker Inventory

    Time frame: Baseline

    A 54-item list which tests psychological responses to physical symptoms.

  4. Pennebaker Inventory

    Time frame: End of Intervention (8 weeks)

    A 54-item list which tests psychological responses to physical symptoms.

  5. State-Trait Anxiety Inventory (STAI)

    Time frame: Baseline

    A 30-item self report scale emphasizing dispositional states (anxiety).

  6. State-Trait Anxiety Inventory (STAI)

    Time frame: End of Intervention (8 weeks)

    A 30-item self report scale emphasizing dispositional states (anxiety).

  7. Positive Health Expectation Scale

    Time frame: Baseline

    A 7-item list which measures positive expectations to predict health after heart transplantation.

  8. 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.

  9. Florida Patient Acceptance Survey (FPAS)

    Time frame: Baseline

    An 18-item list which measures patient acceptance of implantable cardiac device therapy.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Hospitalizations

    Time frame: Baseline

    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  16. Hospitalizations

    Time frame: End of Intervention (8 weeks)

    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  17. Hospitalizations

    Time frame: Six month follow-up

    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  18. Implantation Status

    Time frame: Baseline

    Primary prevention and secondary prevention data from Medical Chart Review.

  19. Medications

    Time frame: Baseline

    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  20. Medications

    Time frame: End of Intervention (8 weeks)

    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  21. Medications

    Time frame: Six month follow-up

    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  22. Co-morbidities

    Time frame: Baseline

    Medical chart review for co-existing morbidities.

  23. Co-morbidities

    Time frame: End of Intervention (8 weeks)

    Medical chart review for co-existing morbidities.

  24. Co-morbidities

    Time frame: Six month follow-up

    Medical chart review for co-existing morbidities.

  25. Ejection Fraction

    Time frame: Baseline

    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  26. Ejection Fraction

    Time frame: End of Intervention (8 weeks)

    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  27. Ejection Fraction

    Time frame: Six month follow-up

    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  28. Atrial Fibrillation

    Time frame: Baseline

    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.

  29. 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.

  30. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Oct 29, 2012
Registry last updated
Oct 29, 2012

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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