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Search / Trial NCT06037785

Self-Management Interventions After an ICD Shock

Launched by UNIVERSITY OF WASHINGTON · Sep 7, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Implantable Cardioverter Defibrillator Ptsd Stress Management

ClinConnect Summary

This clinical trial, titled "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," is studying a new program designed to help patients who have recently received a shock from their Implantable Cardioverter Defibrillator (ICD). The goal of the study is to see if a self-management program, combined with standard care, can reduce anxiety and the risk of developing post-traumatic stress disorder (PTSD) after an ICD shock. Participants will learn skills to manage their heart rate and complete online modules over one month, and researchers will follow up with them for six months to see how they are doing.

To be eligible for this trial, participants must be between 65 and 74 years old, have received an ICD shock within the past week, and be able to read, speak, and write in English. They need access to online resources and a phone for the duration of the study. However, individuals with certain mental health conditions, cognitive dysfunction, or substance abuse issues will not be included. Participants can expect support in managing stress and improving their quality of life during a challenging time after their ICD shock. This study aims to fill an important gap in care for ICD patients and may lead to further research on effective interventions for a wider range of people.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),
  • 2. receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;
  • 3. able to read, speak and write English;
  • 4. access to online resources and telephone for study duration.
  • Exclusion Criteria:
  • 1. current diagnosis of PTSD, schizophrenia or bipolar disorder;
  • 2. Short BLESSED score \>6 indicating cognitive dysfunction \[73\];
  • 3. age \<18 years;
  • 4. AUDIT-C score ≥4 for alcohol use;
  • 5. regular non-medical use of illicit drugs

About University Of Washington

The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.

Locations

Seattle, Washington, United States

Patients applied

0 patients applied

Trial Officials

Cynthia M Dougherty, ARNP, PhD

Principal Investigator

University of Washington

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported