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NCT04596891 · ClinicalTrials.gov registry record · NA
Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
A NA study, sponsored by Research Foundation for Mental Hygiene.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT04596891: Completed NA study, sponsored by Research Foundation for Mental Hygiene.
NCT04596891 is a NA study that has completed, run by Research Foundation for Mental Hygiene. The registered enrollment target is 11 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
NCT04596891, a NA study, has completed, sponsored by Research Foundation for Mental Hygiene.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
The primary goal of this uncontrolled pilot trial is to examine feasibility, acceptability, safety, and preliminary efficacy of a new behavioral treatment for survivors of sudden cardiac arrest with clinically elevated symptoms of post-traumatic stress disorder (PTSD). Participants will be recruited among cardiac arrest survivors enrolled in the observational CANOE research study (CUIMC IRB# AAAR8497). Study participants will be interviewed about their symptoms and evaluated for baseline assessment before receiving eight weekly sessions of an acceptance and mindfulness-based exposure therapy (AMBET). Participants will be additionally evaluated at treatment mid-point (week 4), and at the end of treatment. The treatment and all assessments will be conducted remotely via Zoom. To assess whether patients' physical activity is improved over the course of treatment, participants will be provided with a wearable device (Fitbit wristband) to monitor their physical activity. The specific aims of this study are to: (1) develop an acceptable protocol for an AMBET intervention for survivors of sudden cardiac arrest with elevated PTSD symptoms (2) examine its safety and feasibility in a small sample of 14 patients (3) investigate acceptability and feasibility of the assessments and measurements including physical activity.
Primary Outcome
Reduction in symptoms as measured by the Clinician Administered PTSD Scale (Caps-5: ranging from 0-80 ) from pre- to post-treatment. Lower scores mean better outcome (reduction of symptom severity).
Interventions
- BEHAVIORAL Psychotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2022-04-21 |
| Phase | NA |
What the finished NCT04596891 record still lists
NCT04596891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 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 Psychotherapy is the first listed.
NCT04596891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04596891 about?
NCT04596891 is a clinical study titled "Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest". The primary goal of this uncontrolled pilot trial is to examine feasibility, acceptability, safety, and preliminary efficacy of a new behavioral treatment for survivors of sudden cardiac arrest with clinically elevated symptoms of post-traumatic stress disorder (PTSD). Participants will be recruited...
What is the current status of trial NCT04596891?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2021-03-02. Estimated completion is 2022-04-21.
What interventions are being tested in trial NCT04596891?
The interventions under investigation include: Psychotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04596891?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04596891's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 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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