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NCT06037785 · ClinicalTrials.gov registry record · NA
Self-Management Interventions After an ICD Shock
A NA study of PTSD and Stress Reaction, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06037785: Recruiting NA study of PTSD and Stress Reaction, sponsored by University of Washington.
NCT06037785 is a NA study of PTSD and Stress Reaction that is actively recruiting participants, run by University of Washington. The registered enrollment target is 60 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06037785, a NA study of PTSD and Stress Reaction, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of p
Primary Outcome
Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.
Conditions Studied
Interventions
- BEHAVIORAL Self-Paced Self-Management (SPSM)
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT06037785 shows while recruiting
NCT06037785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (80% lower).
The record links to 5 conditions, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which Self-Paced Self-Management (SPSM) is the first listed.
NCT06037785 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT06037785 about?
NCT06037785 is a clinical study titled "Self-Management Interventions After an ICD Shock". This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delive...
What is the current status of trial NCT06037785?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-10-01. Estimated completion is 2026-07-31.
What conditions does trial NCT06037785 study?
This clinical trial studies the following conditions: PTSD, Stress Reaction, Implantable Defibrillator User, Stress Management, Social Cognitive Theory.
What interventions are being tested in trial NCT06037785?
The interventions under investigation include: Self-Paced Self-Management (SPSM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06037785?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06037785 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06037785's enrollment target sits among peer trials
60 87th of 154 higher than 65 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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