Acceptance- and Mindfulness-Based Exposure Therapy versus Present-Centered Therapy for PTSD after cardiac arrest
A Randomized Clinical Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)
This project will test if Acceptance- and Mindfulness-Based Exposure Therapy (AMBET) or Present-Centered Therapy (PCT) better reduces PTSD symptoms in adults who survived a cardiac arrest.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 81 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07410481 on ClinicalTrials.gov |
What this trial studies
Adults who survived a cardiac arrest more than three months ago and have clinically elevated PTSD symptoms are randomly assigned to receive either AMBET or PCT. Each participant receives 12 hours of individual psychotherapy delivered over about 12 weeks, completes brief weekly online mood and behavior surveys, wears a Fitbit to track sleep and activity, and does short homework between sessions. The trial measures change in PTSD symptoms (using instruments such as the CAPS-5) and other patient-reported and behavioral outcomes to compare the two therapies. Standard psychiatric and medical exclusions apply, and participants must be U.S. residents able to attend the Columbia University site.
Who should consider this trial
Good fit: Ideal candidates are English-speaking U.S. residents aged 18–81 who survived a cardiac arrest more than three months ago and have clinically elevated PTSD symptoms (CAPS-5 ≥25) and who do not have primary psychotic or bipolar disorder, recent moderate/severe substance use disorder, active suicidal intent, substantial cognitive impairment, recent changes in psychotropic medication, or current PTSD psychotherapy.
Not a fit: People with non-cardiac causes of their arrest (e.g., drowning, trauma, overdose), substantial cognitive impairment, recent unstable psychiatric conditions (psychosis, bipolar disorder, recent substance use disorder, active suicidal intent), recent medication changes, terminal illness with life expectancy under a year, or those already in PTSD psychotherapy may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the therapy approach could reduce PTSD symptoms and improve sleep, activity levels, and overall recovery for cardiac arrest survivors.
How similar studies have performed: Exposure-based, acceptance-based, and mindfulness interventions have demonstrated benefit for PTSD in other populations, but combining these methods as AMBET and testing them specifically in cardiac arrest survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Between 18 and 81 years old at the time of consent 2. Fluency in English 3. Medical history of cardiac arrest \>3 months ago 4. Clinically elevated PTSD symptoms (Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score ≥25) 5. U.S. Resident Exclusion Criteria: 1. Lifetime history of primary psychotic or bipolar disorders 2. Current substance use disorder (moderate or severe in the past 6 months) 3. Active suicidal ideation with some intent to act in past 12 months, and/or suicide attempt in past 24 months 4. Substantial cognitive impairment (Mini Mental Status Exam (MMSE) score \<25) 5. Initiation of new psychotropic medication \<3 months ago 6. Non-cardiac etiology of CA (drowning, bleeding, trauma, drug overdose, etc) 7. Terminal illness with life expectancy \<1 year 8. Concurrent psychotherapy for PTSD
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Yuval Neria, PhD — Columbia University
- Study coordinator: Yuval Neria, Ph.D.
- Email: ny126@cumc.columbia.edu
- Phone: 212-543-6061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.