The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study



Status:Completed
Conditions:Anxiety, Anxiety, Depression, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:6 - 20
Updated:4/14/2017
Start Date:August 2009
End Date:October 2010

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The ICD/Device Expectations, Adaptations, and Successes (IDEAS) Study: the Relationship Between Implantable Cardioverter-defibrillators, Pacemakers and Psychiatric Symptoms in a Pediatric Population

The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has
substantially changed the medical and surgical management of patients with cardiac rhythm
disease. In the case of patients with ICDs, these devices are programmed to deliver a strong
electrical shocks. In adults, multiple studies have suggested that patients at risk of
receiving shocks from their device have an increased prevalence of anxiety and depression.
Very few studies have looked at this question in children. We propose to evaluate a cohort
of patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers,
assessing each group for the presence of depressive and anxiety disorders, including
post-traumatic stress disorder (PTSD).


Inclusion Criteria:

- Age 6 through 20 at the time of enrollment for patients.

- Age ≥18 for caregiver

- Functioning pacemaker or ICD (explanted or inoperative devices do not qualify)

- Informed consent of parent or guardian as well as assent of study participant

Exclusion Criteria:

- Lack of English language fluency in patient and caregiver

- Hospitalization within 4 weeks of visit

- First implantation of ICD or pacemaker within 6 months of study enrollment
We found this trial at
1
site
Boston, Massachusetts 02115
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from
Boston, MA
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