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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elena Salmoirago-Blotcher, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01035294
First received: November 20, 2009
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Anxiety Disorder in Conditions Classified Elsewhere
Behavioral: mindfulness based intervention (MBI)
Behavioral: usual care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Study feasibility [ Time Frame: post-intervention (9 weeks after enrollment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital Anxiety and Depression (HAD) anxiety scores [ Time Frame: baseline and post-intervention (9 weeks) ] [ Designated as safety issue: No ]
  • Five Factors of Mindfulness scores (FFM) [ Time Frame: baseline and post-intervention (9 weeks) ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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:

  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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 21
  2. ICD procedure
  3. Ability to understand and speak English
  4. Access to a telephone

Exclusion Criteria:

  1. Inability or unwillingness to give informed consent
  2. Signs of cognitive impairment (Blessed Orientation-Memory-Concentration (BOMS)scores >10)
  3. New York Heart Association (NYHA) functional class>III, angina Canadian Cardiovascular Society(CCS) III and IV or clinically unstable
  4. Awaiting coronary by-pass or heart transplantation
  5. Co-morbid life threatening condition
  6. Ongoing severe depression or psychosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035294

Locations
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Elena Salmoirago-Blotcher, MD University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Elena Salmoirago-Blotcher, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01035294     History of Changes
Other Study ID Numbers: H-13078, 1F32AT005048-01A1
Study First Received: November 20, 2009
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 23, 2014