A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients
|Anxiety Disorder in Conditions Classified Elsewhere||Behavioral: mindfulness based intervention (MBI) Behavioral: usual care||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Mindfulness-based Intervention for Treatment of Anxiety in ICD Patients|
- Study feasibility [ Time Frame: post-intervention (9 weeks after enrollment) ]
- Hospital Anxiety and Depression (HAD) anxiety scores [ Time Frame: baseline and post-intervention (9 weeks) ]
- Five Factors of Mindfulness scores (FFM) [ Time Frame: baseline and post-intervention (9 weeks) ]
|Study Start Date:||July 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: mindfulness based intervention||
Behavioral: mindfulness based intervention (MBI)
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.
|Active Comparator: usual care (UC)||
Behavioral: usual care
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).
The Specific Aims of this pilot study are:
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035294
|United States, Massachusetts|
|UMass Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Elena Salmoirago-Blotcher, MD||University of Massachusetts, Worcester|