NCT07410481

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

February 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

February 8, 2026

Last Update Submit

April 4, 2026

Conditions

PTSD - Post Traumatic Stress DisorderCardiac Arrest (CA)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in depressive symptoms over time

    Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake

Study Arms (2)

Acceptance- and mindfulness-based exposure therapy (AMBET)

EXPERIMENTAL

Remotely delivered psychotherapy combining exposure therapy with mindfulness.

Behavioral: Acceptance and Mindfulness Based Exposure Therapy

Present-Centered Therapy (PCT)

ACTIVE COMPARATOR

Remotely delivered psychotherapy that focuses on increasing adaptive responses to current life stressors and difficulties.

Behavioral: Present-Centered Therapy

Interventions

Acceptance and Mindfulness Based Exposure TherapyBEHAVIORAL

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.

Also known as: AMBET
Acceptance- and mindfulness-based exposure therapy (AMBET)
Present-Centered TherapyBEHAVIORAL

Twelve 60-minute weekly sessions of psychotherapy delivered via videoconferencing platform.

Also known as: PCT
Present-Centered Therapy (PCT)

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18 and 81 years old at the time of consent
  • Fluency in English
  • Medical history of cardiac arrest \>3 months ago
  • Clinically elevated PTSD symptoms (Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score ≥25)
  • U.S. Resident

You may not qualify if:

  • Lifetime history of primary psychotic or bipolar disorders
  • Current substance use disorder (moderate or severe in the past 6 months)
  • Active suicidal ideation with some intent to act in past 12 months, and/or suicide attempt in past 24 months
  • Substantial cognitive impairment (Mini Mental Status Exam (MMSE) score \<25)
  • Initiation of new psychotropic medication \<3 months ago
  • Non-cardiac etiology of CA (drowning, bleeding, trauma, drug overdose, etc)
  • Terminal illness with life expectancy \<1 year
  • Concurrent psychotherapy for PTSD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Combat DisordersHeart Arrest

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersHeart DiseasesCardiovascular Diseases

Study Officials

  • Yuval Neria, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Maja Bergman, PhD

    Columbia University

    STUDY DIRECTOR

Central Study Contacts

Yuval Neria, Ph.D.

CONTACT

212-543-6061ny126@cumc.columbia.edu

Maja Bergman, Ph.D.

CONTACT

212-543-6061mb3829@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Medical Psychology

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 13, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(1)