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Behavioral Intervention

Self-Management Training for Stress Reaction After ICD Shock

N/A
Waitlist Available
Led By Cynthia M Dougherty, ARNP, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial looks at a self-management intervention to reduce anxiety and improve quality of life after an ICD shock. It includes training in heart rate monitoring and 4 self-paced, web-based modules. Feasibility, acceptability, and safety of the intervention are assessed. Results will inform future larger trials.

Who is the study for?
This trial is for adults with an implanted cardioverter-defibrillator (ICD) who've had a shock from it within the last week. They must have internet and phone access, speak English, and not have PTSD, schizophrenia, bipolar disorder, cognitive dysfunction or substance abuse issues.Check my eligibility
What is being tested?
The study tests a self-management program delivered online to reduce anxiety and prevent PTSD after an ICD shock. It compares this program plus usual care against usual care alone over one month with follow-up at six months to check long-term effects.See study design
What are the potential side effects?
Since the intervention involves self-paced learning and heart rate monitoring without medication or invasive procedures, significant side effects are not expected. However, participants may experience stress or discomfort related to focusing on their health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ICD Shock anxiety
Secondary outcome measures
Acceptability
Depression
Feasibility
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SPSM interventionExperimental Treatment1 Intervention
Heart rate self monitoring Online shock management modules
Group II: usual careActive Control1 Intervention
standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,291 Total Patients Enrolled
East Carolina UniversityOTHER
107 Previous Clinical Trials
38,749 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,376,322 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this research endeavor?

"Per the information on clinicaltrials.gov, this research no longer requires additional participants. It was first published in December 1st 2023 and last modified on September 7th 2023. Although participation is not being solicited for this study anymore, there are 45 other medical experiments presently searching for volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Self-Management Interventions After an ICD Shock
Cynthia M. Dougherty 2023. "Self-Management Interventions After an ICD Shock". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06037785.
~40 spots leftby Jul 2025
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