Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)

A Randomized Clinical Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)

The goal of this clinical trial is to learn if a new therapy called Acceptance- and Mindfulness-Based Exposure Therapy (AMBET) helps treat post-traumatic stress disorder (PTSD) in people who survived a cardiac arrest. This study will compare AMBET to another psychotherapy treatment called Present Centered Therapy (PCT) to see which therapy is more effective in treating PTSD.

The main questions it aims to answer are:

Does AMBET reduce PTSD symptoms in survivors of cardiac arrest? How do the benefits of AMBET compare to PCT?

Participants will:

• Be randomly assigned to receive either AMBET or PCT
• Attend 12 hours of individual psychotherapy sessions over about 12 weeks
• Complete short weekly surveys about their mood and behaviors online
• Wear a Fitbit device to track sleep and activity during the study
• Do brief homework assignments between sessions

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest (CA); PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Acceptance and Mindfulness Based Exposure Therapy; Behavioral: Present-Centered Therapy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuval Neria, Ph.D.; Phone Number: 212-543-6061; Email: ny126@cumc.columbia.edu
• Study Contact Backup: Name: Maja Bergman, Ph.D.; Phone Number: 212-543-6061; Email: mb3829@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Maja Bergman, Ph.D.; Email: mb3829@cumc.columbia.edu
      • Principal Investigator: Yuval Neria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance- and mindfulness-based exposure therapy (AMBET); Remotely delivered psychotherapy combining exposure therapy with mindfulness.	Behavioral: Acceptance and Mindfulness Based Exposure Therapy; Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform. AMBET will consist of 90-minute weekly sessions for 4 weeks, then every other week for 4 more sessions.; Other Names: AMBET
Active Comparator: Present-Centered Therapy (PCT); Remotely delivered psychotherapy that focuses on increasing adaptive responses to current life stressors and difficulties.	Behavioral: Present-Centered Therapy; Twelve 60-minute weekly sessions of psychotherapy delivered via videoconferencing platform.; Other Names: PCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms over time	Change in symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5) from pre- to post-treatment. The full score range is 0 - 80, where lower scores indicate lower symptom levels of PTSD.	Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms over time	Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-24) from pre- to post-treatment. The full score range is 0 - 76, where lower scores indicate lower symptom levels of depression.	Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Yuval Neria, PhD, Columbia University; Study Director: Maja Bergman, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Cardiovascular Diseases; Mental Disorders; Heart Diseases; Stress Disorders, Traumatic; Heart Arrest; Combat Disorders
• Other Study ID Numbers: AAAV5860; P30AG064198-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No