NCT00627263

Brief Summary

An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms. Arrhythmias can be caused by many factors, including stress and anger. This study will evaluate the use of a stress reduction treatment (SRT) program aimed at reducing the occurrence of arrhythmias that require treatment with an ICD shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

February 28, 2008

Last Update Submit

January 12, 2018

Conditions

Arrhythmias, Cardiac

Keywords

ICDCardiac ArrhythmiaArrhythmiaStressAnger

Outcome Measures

Primary Outcomes (1)

  • ICD shock-treated ventricular arrhythmia event-free survival

    The occurrence of ICD shock treated ventricular arrhythmia

    Measured at Month 24

Secondary Outcomes (3)

  • Laboratory stress-provoked arrhythmogenic changes in the heart rhythm

    Measured at Baseline and Month 6

  • 24-hour heart rate variability

    Measured at Baseline and Month 6

  • Quality of life

    Measured at Month 24

Study Arms (2)

1

NO INTERVENTION

Participants will receive the usual cardiologic care for ICD patients provided by their medical team.

2

EXPERIMENTAL

In addition to the usual cardiologic care for ICD patients provided by the participants medical team, those randomized to Intervention will receive the stress reduction treatment (SRT) program (see below).

Behavioral: Stress reduction treatment (SRT) program

Interventions

Stress reduction treatment (SRT) programBEHAVIORAL

The SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving an ICD or currently have an ICD and have recieved appropriated ICD shock therapy in the 6 months before study entry
  • Ischemic cardiomyopathy or non-ischemic (dilated) cardiomyopathy
  • Fluent in spoken and written English
  • Able to participate in the SRT program

You may not qualify if:

  • Unable to comply with the study or participate in SRT treatment, if assigned
  • Incapacitating illness (e.g., stage IV congestive heart failure) that would interfere with study participation
  • Life expectancy of less than 2 years (e.g., due to metastatic cancer)
  • Uncommon etiologies of arrhythmia (e.g., long QT syndrome, hypertrophic cardiomyopathy, Brugada syndrome)
  • Cognitive impairment, based on Mini-Mental Status Exam (MMSE) and educational level. If education level is less than 8th grade, then people with an MMSE score of less than 17 will not be enrolled; if education level is greater than 8th grade, then people with an MMSE score of less than 24 will not be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University Medical School

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Donahue RG, Lampert R, Dornelas E, Clemow L, Burg MM; RISTA Investigators. Rationale and design of a randomized clinical trial comparing stress reduction treatment to usual cardiac care: the Reducing Vulnerability to Implantable Cardioverter Defibrillator Shock-Treated Ventricular Arrhythmias (RISTA) trial. Psychosom Med. 2010 Feb;72(2):172-7. doi: 10.1097/PSY.0b013e3181c932d4. Epub 2009 Dec 22.

    PMID: 20028832DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew M. Burg, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 3, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

US(1)