MedDataX Logo

Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient

NCT ID: NCT00851071

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2017-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will compare the effectiveness that Cognitive Behavioral Therapy has on decreasing the amount of anxiety, as well as the number of inappropriate firings that a patient with an ICD may experience.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is an interventional study of patients with ICDs followed in the Cleveland Clinic Device Clinic. Patients with ICDs experience some level of anxiety which can impact the number of shocks that they receive from their Device. 100 of these patients will be randomized into one of 2 groups; those receiving three sessions of Cognitive Behavioral Therapy (CBT) and those receiving usual care. We hypothesize that if these ICD patients receive short term (CBT) they will experience less anxiety and have a lower rate of device firings than the patients that did not receive CBT. Furthermore, we will study mechanistic pathways involved in the reduction of anxiety in ICD patients. We will extract initial heart rate variability (HRV) data from device interrogation. We hypothesize that the CBT intervention arm will have a higher normalization of HRV. Patients will repeat questionnaires at 3, 6 and 12 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Anxiety Implantable Cardioverter Defibrillator (ICD) Defibrillators, Implantable

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive Behavioral Therapy

Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Three 45 minute CBT sessions scheduled over a 3 month period.

Usual Care Arm

The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Behavioral Therapy

Three 45 minute CBT sessions scheduled over a 3 month period.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Currently has an Implantable Cardioverter Defibrillator (ICD)
* Experiences moderate to high anxiety as demonstrated by the the scores on the questionnaires that will be administered

Exclusion Criteria

* Unwilling to comply with follow-up requirements at 3, 6 and 12 months.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mina Chung

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mina K Chung, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Leopoldo J Pozuelo, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Qintar M, George JJ, Panko M, Bea S, Broer KA, St John J, Blissett KA, Ching E, Sears SF, Pedersen SS, Pozuelo L, Chung MK. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety. J Interv Card Electrophysiol. 2015 Jun;43(1):65-75. doi: 10.1007/s10840-015-9990-7. Epub 2015 Mar 17.

Reference Type DERIVED
PMID: 25779222 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Publication

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB# 08-913

Identifier Type: -

Identifier Source: org_study_id