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Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest

NCT04596891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-04-08

Study results available
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Summary

The primary goal of this uncontrolled pilot trial is to examine feasibility, acceptability, safety, and preliminary efficacy of a new behavioral treatment for survivors of sudden cardiac arrest with clinically elevated symptoms of post-traumatic stress disorder (PTSD). Participants will be recruited among cardiac arrest survivors enrolled in the observational CANOE research study (CUIMC IRB# AAAR8497). Study participants will be interviewed about their symptoms and evaluated for baseline assessment before receiving eight weekly sessions of an acceptance and mindfulness-based exposure therapy (AMBET). Participants will be additionally evaluated at treatment mid-point (week 4), and at the end of treatment.

The treatment and all assessments will be conducted remotely via Zoom. To assess whether patients' physical activity is improved over the course of treatment, participants will be provided with a wearable device (Fitbit wristband) to monitor their physical activity.

The specific aims of this study are to: (1) develop an acceptable protocol for an AMBET intervention for survivors of sudden cardiac arrest with elevated PTSD symptoms (2) examine its safety and feasibility in a small sample of 14 patients (3) investigate acceptability and feasibility of the assessments and measurements including physical activity.

Conditions

  • PTSD
  • Cardiac Arrest

Interventions

BEHAVIORAL

Psychotherapy

Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • Research Foundation for Mental Hygiene, Inc.

    lead OTHER

Principal Investigators

  • Yuval Neria, PhD · Columbia University and NYSPI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2022-04-21
Completion
2022-04-21

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596891 on ClinicalTrials.gov