Meta description: A regulatory minded update on two behavioral therapies for PTSD after cardiac arrest, now listed as not yet recruiting in a Columbia University led trial.
A regulatory minded update highlights a new trial that focuses on PTSD after cardiac arrest. The study compares Acceptance and Mindfulness Based Exposure Therapy and Present Centered Therapy. The trial is listed as sponsored by Columbia University and funded by the National Institute on Aging. The status is Not yet recruiting as of February 15, 2026. The record provides a concise view of the therapies and the parties involved, without presenting results or safety data. Stakeholders in clinical and regulatory teams may find this entry relevant for planning future trials and for mapping potential pathways to patient care.
What is being studied?
The record lists PTSD as the target condition and Cardiac Arrest as the related event. The interventions are described as Behavioral: Acceptance and Mindfulness Based Exposure Therapy and Behavioral: Present Centered Therapy. The work is led by a sponsor identified as Columbia University with support from the National Institute on Aging. The text does not specify a primary endpoint enrollment details or a comparison design. It also does not provide efficacy data. The entry clearly states the interventions intended for study and the organizations behind the project.
Acceptance and Mindfulness Based Exposure Therapy is designated by the acronym AMBET in the source. Present Centered Therapy is listed as the second behavioral intervention. Together these approaches reflect non pharmacologic options for PTSD that are commonly explored in clinical research. The description aligns with a behavioral therapy focus rather than a device oriented approach. The record does not indicate a product under investigation, but the trial falls within the scope of a regulated clinical research program.
What changed in trial status?
The entry notes Not yet recruiting as of the source date. This signals that participant enrollment has not started. The documented date is February 15, 2026. No patient numbers sites or amendments are described in the record. Clinicians and researchers may view this status as an early milestone in the lifecycle of a behavioral therapy trial. The lack of recruitment information limits interpretation but does not negate the existence of the regulatory submission and registry posting.
Who sponsors and funds the study?
Sponsors are Columbia University. The National Institute on Aging is listed as a funder. This combination shows public and academic collaboration in the field of aging and trauma research. The entry documents the involvement of a major academic center and a federal funding agency. No additional sponsors or industrial partners are named in the record. The information supports the understanding that the trial is positioned within public sector research infrastructure rather than a for profit product development program.
What this means for patients and clinicians?
From a clinical regulatory perspective the entry signals a potential future option for PTSD management after cardiac events. The therapies named are behavioral in nature and do not imply a device. The registry status will guide ongoing oversight and transparency requirements. Clinicians may want to monitor updates for enrollment criteria changes or protocol disclosures. Patients and caregivers should recognize that this entry is an early stage record and that no outcomes are reported yet.
Are there safety considerations or oversight notes?
The source text provides no safety data. In regulatory practice a trial of behavioral therapy would still require appropriate consent documentation data protection and reporting of adverse events to the registry. The MDR oriented framework would require clear statements of intended use and safety considerations once a full protocol is released. Without trial results users should treat the entry as a status update rather than a claim of clinical benefit.
Conclusion
The AMBET and Present Centered Therapy trial for PTSD after cardiac arrest reflects ongoing regulatory work in behavioral therapy research. Stakeholders should track future updates on enrollment design and sponsor statements. The registry entry provides a basis for ongoing evaluation and potential regulatory filings.
Disclaimer
This article is for professional readers. It is not legal advice. It does not replace regulatory counsel or the duty to review primary registry documents for precise requirements.
FAQ
- 1. What therapies are being studied? The trial lists Acceptance and Mindfulness Based Exposure Therapy and Present Centered Therapy.
- 2. What conditions are included? PTSD and Cardiac Arrest are listed.
- 3. Who funds the study? Columbia University and the National Institute on Aging.
- 4. What is the recruitment status? Not yet recruiting.
- 5. Where can I find more information? The registry link is provided in the article.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07410481?term=medical+device