Clinical trial NCT01716351: The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
Official title: The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmias
Keywords: Randomized Clinical Control Trial
Complementary and Alternative Medicine
Yoga
Electrophysiology
Implantable Cardioverter Defibrillator
Psychosocial
Anxiety
Self-Compassion
Anti-Tachycardia Pacing Events
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-10-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Florida Shock Anxiety Scale (FSAS)
timeFrame: Baseline
measure: Florida Shock Anxiety Scale (FSAS)
timeFrame: End of Intervention (8 weeks)
measure: Self-Compassion Scale
timeFrame: Baseline
measure: Self-Compassion Scale
timeFrame: End of Intervention (8 weeks)
measure: The number of device-initiated ventricular defibrillations as recorded by their ICD device
timeFrame: Baseline
measure: The number of device-initiated ventricular defibrillations as recorded by their ICD device
timeFrame: Six month follow-up
measure: The number of anti-tachycardia pacing events among participants as recorded by their ICD device
timeFrame: Baseline
measure: The number of anti-tachycardia pacing events among participants as recorded by their ICD device
timeFrame: End of Intervention (8 weeks)
measure: The number of anti-tachycardia pacing events among participants as recorded by their ICD device
timeFrame: Six month follow-up
Secondary outcomes:
measure: Expression Manipulation Test
timeFrame: Baseline
measure: Expression Manipulation Test
timeFrame: End of Intervention (8 weeks)
measure: Pennebaker Inventory
timeFrame: Baseline
measure: Pennebaker Inventory
timeFrame: End of Intervention (8 weeks)
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: End of Intervention (8 weeks)
measure: Positive Health Expectation Scale
timeFrame: Baseline
measure: Positive Health Expectation Scale
timeFrame: End of Intervention (8 weeks)
measure: Florida Patient Acceptance Survey (FPAS)
timeFrame: Baseline
measure: Florida Patient Acceptance Survey (FPAS)
timeFrame: End of Intervention (8 weeks)
measure: Center for Epidemiologic Study Depression Scale (CES-D)
timeFrame: Baseline
measure: Center for Epidemiologic Study Depression Scale (CES-D)
timeFrame: End of Intervention (8 weeks)
measure: Interpersonal Support Evaluation
timeFrame: Baseline
measure: Interpersonal Support Evaluation
timeFrame: End of Intervention (8 weeks)
measure: Hospitalizations
timeFrame: Baseline
measure: Hospitalizations
timeFrame: End of Intervention (8 weeks)
measure: Hospitalizations
timeFrame: Six month follow-up
measure: Implantation Status
timeFrame: Baseline
measure: Medications
timeFrame: Baseline
measure: Medications
timeFrame: End of Intervention (8 weeks)
measure: Medications
timeFrame: Six month follow-up
measure: Co-morbidities
timeFrame: Baseline
measure: Co-morbidities
timeFrame: End of Intervention (8 weeks)
measure: Co-morbidities
timeFrame: Six month follow-up
measure: Ejection Fraction
timeFrame: Baseline
measure: Ejection Fraction
timeFrame: End of Intervention (8 weeks)
measure: Ejection Fraction
timeFrame: Six month follow-up
measure: Atrial Fibrillation
timeFrame: Baseline
measure: Atrial Fibrillation
timeFrame: End of Intervention (8 weeks)
measure: Atrial Fibrillation
timeFrame: Six month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Yale New Haven Hospital, St. Raphael Campus
name: Stefanie CF Toise, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale New Haven Hospital, St. Raphael Campus
name: Thomas J Donohue, MD
role: STUDY_DIRECTOR
References: