A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients

Completed · Phase 2/Phase 3

Conditions studied: Anxiety Disorder in Conditions Classified Elsewhere

In brief

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).

Key facts

Study ID

NCT01035294

Run by

University of Massachusetts, Worcester

People needed

46

Starts

2009-07-01

Expected to finish

2011-12-01

Last updated by the study team

2012-01-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 21
• ICD procedure
• Ability to understand and speak English
• Access to a telephone

You may not qualify if…

• Inability or unwillingness to give informed consent
• Signs of cognitive impairment (Blessed Orientation-Memory-Concentration (BOMS)scores >10)
• New York Heart Association (NYHA) functional class>III, angina Canadian Cardiovascular Society(CCS) III and IV or clinically unstable
• Awaiting coronary by-pass or heart transplantation
• Co-morbid life threatening condition
• Ongoing severe depression or psychosis

Where it is running

• UMass Memorial Medical Center — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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