A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients
Primary Purpose
Anxiety Disorder in Conditions Classified Elsewhere
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mindfulness based intervention (MBI)
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder in Conditions Classified Elsewhere
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 21
- ICD procedure
- Ability to understand and speak English
- Access to a telephone
Exclusion Criteria:
- 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
Sites / Locations
- UMass Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mindfulness based intervention
usual care (UC)
Arm Description
Outcomes
Primary Outcome Measures
Study feasibility
Secondary Outcome Measures
Hospital Anxiety and Depression (HAD) anxiety scores
Five Factors of Mindfulness scores (FFM)
Full Information
NCT ID
NCT01035294
First Posted
November 20, 2009
Last Updated
January 25, 2012
Sponsor
University of Massachusetts, Worcester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01035294
Brief Title
A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients
Official Title
A Mindfulness-based Intervention for Treatment of Anxiety in ICD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder in Conditions Classified Elsewhere
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mindfulness based intervention
Arm Type
Experimental
Arm Title
usual care (UC)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
mindfulness based intervention (MBI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Study feasibility
Time Frame
post-intervention (9 weeks after enrollment)
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression (HAD) anxiety scores
Time Frame
baseline and post-intervention (9 weeks)
Title
Five Factors of Mindfulness scores (FFM)
Time Frame
baseline and post-intervention (9 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 21
ICD procedure
Ability to understand and speak English
Access to a telephone
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Salmoirago-Blotcher, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Mindfulness-based Intervention for Treatment of Anxiety in ICD (Implantable Cardioverter Defibrillator) Patients
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