Self-management support for patients after receiving an ICD shock
Official title: Biobehavioral Intervention to Reduce PTSD After ICD Shock
Run by University of Washington · NCT06037785 · Data updated 2026-11-12
This study is testing a new support program for people who have just received a shock from their ICD to see if it can help reduce anxiety and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT06037785 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who have received an ICD shock within the past week and are able to engage with online resources.
✕Probably not a fit
Patients with current PTSD, severe cognitive dysfunction, or those under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the feasibility and acceptability of a self-management intervention for patients who have recently experienced a shock from an implantable cardioverter defibrillator (ICD). The intervention aims to reduce anxiety and prevent the development of post-traumatic stress disorder (PTSD) by providing support during the critical month following the shock. Participants will be randomly assigned to receive either the self-management intervention along with usual care or usual care alone. The study will assess outcomes over a six-month follow-up period to determine the effectiveness of the intervention in enhancing quality of life and daily functioning.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for patients recovering from an ICD shock.
How similar studies have gone: Other studies have shown promise in using self-management interventions for similar patient populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Washington
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Cynthia M Dougherty, ARNP, PhD — University of Washington
- Study coordinator: Cynthia M Dougherty, ARNP, PhD
- Email: cindyd@uw.edu
- Phone: 206 221-7927
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.