A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients
| Status: | Archived |
|---|---|
| Conditions: | Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2009 |
| End Date: | September 2011 |
A Mindfulness-based Intervention for Treatment of Anxiety in ICD Patients
The purpose of this study is to evaluate the feasibility and preliminary efficacy of a
mindfulness-based behavioral intervention combining breathing and other relaxation exercises
on symptoms of anxiety in patients undergoing the implantation of an implantable
cardioverter defibrillator. This study will pilot test the feasibility and preliminary
efficacy of a mindfulness-based intervention intended to improve mindfulness and anxiety
levels in ICD (Implantable Cardioverter Defibrillators) patients. A randomized controlled
study design will be used, in which an 8 session phone-delivered mindfulness intervention
will be compared to a usual care condition among consecutive candidates for ICD procedures.
The study will be conducted at the Electrophysiology (EPS) Unit at the UMass Memorial
Medical Center. Assessments will be performed at baseline and at the end of the
intervention (9 weeks after enrollment).
The Specific Aims of this pilot study are:
Primary aim:
To determine the feasibility of a randomized clinical trial of a phone-administered,
mindfulness-based training program, as measured by recruitment and retention rates,
treatment adherence and fidelity.
Secondary aims:
1. To obtain preliminary estimates of the effect of a phone delivered mindfulness-based
intervention on mindfulness levels, measured as the difference between baseline and
post-intervention Five Factors of Mindfulness scores (FFM) in the intervention and in
the control group at the end of the intervention. Hypothesis: Mindfulness levels will
improve in the intervention group compared to the control group.
2. To obtain preliminary estimates of the effect of a phone delivered, mindfulness-based
intervention on anxiety, measured as the difference between baseline and
post-intervention Hospital Anxiety and Depression (HAD) anxiety scores in the
intervention and in the control group at the end of the intervention. Hypothesis:
Anxiety levels will be reduced in the intervention group, compared to the control
group.
3. To collect preliminary data about the number of arrhythmic episodes/administered shocks
during the intervention period. Hypothesis: the proportion of patients experiencing
arrhythmic events/shocks will decrease in the intervention vs. the control group.
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