NCT01035294|CompletedPhase 2/3DMC
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Sponsor study identifier
Secondary identifiers
interventional
46
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 20, 2009
Actual (reported)December 18, 2009
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)Study feasibility
post-intervention (9 weeks after enrollment)
Hospital Anxiety and Depression (HAD) anxiety scores
baseline and post-intervention (9 weeks)
Five Factors of Mindfulness scores (FFM)
baseline and post-intervention (9 weeks)
Eight, phone delivered, individual mindfulness sessions. Each training session will last 30 minutes (20 minutes for intervention + an additional 10 minutes for questions, answers, and for scheduling the next intervention. Patients will also receive instructions to practice at home every day, at least once a day, for at least 15 minutes. An audio CD containing guided mindfulness exercises will be given to the patient at the beginning of the study, to guide them during their home practice. The CD consists of sequences of different mindfulness techniques, consistent with the techniques learned during each session with the instructor. Each patient will record the minutes of mindfulness practice in a diary to be kept daily.
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Elena Salmoirago-Blotcher, MD
University of Massachusetts, Worcester
46 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2009
First Posted
December 18, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Promoting Physical Activity Among Patients With Type 2 Diabetes
The UC group will be offered the standard care planned by the hospital, which includes the routine care provided by the electrophysiology team and other health care professionals that the patient may see over the course of the ICD experience. All patients receive a number of printed education materials and participate to support meetings for ICD patients four times a year. Being part of the standard care offered at UMass Memorial Medical Center, these meetings are offered to all patients regardless of their assignment (thus including patients assigned to the MBI arm).
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Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
January 30, 2012
Record last verified: 2012-01
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Source: ClinicalTrials.gov.
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