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NCT03605693 · ClinicalTrials.gov registry record · NA
Early Psychological Intervention to Prevent Cardiovascular Event-Induced PTSD (REACH Sub-study)
A NA study, sponsored by Columbia University.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03605693: Clinical Trial NA study, sponsored by Columbia University.
NCT03605693 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605693, a NA study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The overall purpose of this project is to determine the feasibility of conducting a randomized clinical trial that compares written exposure therapy with usual care among patients at risk for cardiovascular event-induced PTSD. Patients hospitalized with acute cardiovascular events, including strokes, heart attacks, and cardiac arrest are at risk of developing post-traumatic stress disorder (PTSD) due to the trauma of the acute medical event. The goal of this study is to test the feasibility of conducting a randomized trial involving a psychological intervention to prevent the development of PTSD symptoms in patients at risk for PTSD. Patients who are admitted with these acute cardiovascular events will first be screened for PTSD risk factors while in-hospital after the index event. These risk factors will include elevated threat perceptions at the time of presentation to the hospital or early symptoms of PTSD due to the cardiovascular event. Patients at elevated risk for PTSD will then be randomized to the intervention group or usual care. Those assigned to the intervention will participate in 5 sessions of written exposure therapy in which they are asked to write about the experience of their cardiovascular event with guidance from a trained study clinician. At 1 month after discharge, all patients will be contacted by phone to complete a questionnaire that assesses PTSD symptoms related to the cardiovascular event. Descriptive statistics will be used to understand the feasibility of testing the written exposure therapy intervention as part of a larger, fully powered clinical trial.
Primary Outcome
This is to measure PTSD symptoms due to the index cardiovascular event. The PCL-S is self-report measure of the symptoms of PTSD. Respondents rate how much they were bothered by 20 symptoms, each rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely), such that total scores range from 0-80. The PCL-S (specific stressor) asks respondents about symptoms in relation to an identified stressful experience. The PCL-S aims to link symptom endorsements to the index cardiovascular event
Interventions
- BEHAVIORAL Written Exposure Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
Why NCT03605693 stopped before completion
NCT03605693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Written Exposure Therapy is the first listed.
NCT03605693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03605693 about?
NCT03605693 is a clinical study titled "Early Psychological Intervention to Prevent Cardiovascular Event-Induced PTSD (REACH Sub-study)". The overall purpose of this project is to determine the feasibility of conducting a randomized clinical trial that compares written exposure therapy with usual care among patients at risk for cardiovascular event-induced PTSD. Patients hospitalized with acute cardiovascular events, including stroke...
What is the current status of trial NCT03605693?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2018-08-01. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03605693?
The interventions under investigation include: Written Exposure Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03605693?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03605693's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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