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

NCT01035294 | Completed Phase 2 DMC

• 2 other identifiers: H-130781F32AT005048-01A1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety Disorder in Conditions Classified Elsewhere

Outcome Measures

Primary Outcomes (1)

• Study feasibility

  post-intervention (9 weeks after enrollment)

Secondary Outcomes (2)

• 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)

Study Arms (2)

mindfulness based intervention

EXPERIMENTAL

Behavioral: mindfulness based intervention (MBI)

usual care (UC)

ACTIVE COMPARATOR

Behavioral: usual care

Interventions

mindfulness based intervention (MBI) BEHAVIORAL

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.

mindfulness based intervention

usual care BEHAVIORAL

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).

usual care (UC)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Study Officials

• Elena Salmoirago-Blotcher, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: December 18, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 30, 2012

Record last verified: 2012-01

Locations

US (1)