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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07410481

Enrollment

Registered

2026-02-13

Start date

2026-03-31

Completion date

2029-03-31

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest (CA), PTSD - Post Traumatic Stress Disorder

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

Interventions

BEHAVIORALAcceptance 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.

BEHAVIORALPresent-Centered Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 81 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in PTSD symptoms over time	Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake	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.

Secondary

Measure	Time frame	Description
Change in depressive symptoms over time	Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake	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.

Countries

United States

Contacts

CONTACTYuval Neria, Ph.D.

ny126@cumc.columbia.edu212-543-6061

CONTACTMaja Bergman, Ph.D.

mb3829@cumc.columbia.edu212-543-6061

PRINCIPAL_INVESTIGATORYuval Neria, PhD

Columbia University

STUDY_DIRECTORMaja Bergman, PhD