Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest

NCT04596891 | Completed Results

• 1 other identifier: 8017
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Change in PTSD Symptoms Over Time

  Reduction in symptoms as measured by the Clinician Administered PTSD Scale (Caps-5: ranging from 0-80 ) from pre- to post-treatment. Lower scores mean better outcome (reduction of symptom severity).

  Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake

• Change in Medication Adherence Over Time

  Participants' cardiac medication adherence is measured by self-report using the Morisky Medication Adherence Scale (MMAS). Scores can range from 0-8. If a patient scores higher on the scale, they are evaluated as more adherent.

  End of treatment: approximately 3 months from intake

• Change in Physical Activity Over Time

  Participants level of physical activity is measured objectively by a wrist worn Fitbit device.

  End of treatment: approximately 3 months from intake

Secondary Outcomes (5)

• Participant Satisfaction With Treatment

  End of treatment: approximately 3 months from intake

• Proportion of Participants Who Complete the Study Protocol

  End of treatment: approximately 3 months from intake

• Change in Depressive Symptoms Over Time

  At Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake

• Change in Interoceptive Attention Style Over Time

  Baseline, Post-treatment: approximately 3 months from intake

• Change in Cardiac Anxiety

  Baseline, Post-treatment: approximately 3 months from intake

Study Arms (1)

Intervention

EXPERIMENTAL

Remotely delivered psychotherapy combining exposure therapy with mindfulness

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the age of 18-85
• A PCL-5 score of ≥ 33 at most recent assessment (≥ 30 days post cardiac arrest)
• Hospitalization for cardiac arrest with cardiac etiology at any time in the past.

You may not qualify if:

• Heart failure with severe systolic dysfunction (ejection fraction ≤ 25%)
• Terminal non-cardiovascular illness with life expectancy \<1 year
• History of psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder
• Current severe depression determined by a) a score of \>25 on the Hamilton Rating Scale for Depression (HAM-D-17-item), and b) clinical assessment.
• Significant cognitive impairment defined by Cerebral Performance Category Score ≥3, and/or MMSE score of \<24 neurological impairment precluding ability to complete study questionnaires.
• Active suicidal ideation or behavior.
• Current primary diagnosis of bipolar disorder.
• Current unstable or untreated medical illness.
• Current drug or alcohol misuse: severe alcohol/cannabis or any other substance use disorder (except nicotine).
• Recent psychotropic medication change or initiation within the last 3 months.
• Initiation of other psychotherapy within the last 3 months.

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead
• Columbia University: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Bergman M, Markowitz JC, Kronish IM, Agarwal S, Fisch CT, Eder-Moreau E, Neria Y. Acceptance and Mindfulness-Based Exposure Therapy for PTSD After Cardiac Arrest: An Open Feasibility Trial. J Clin Psychiatry. 2023 Nov 22;85(1):23m14883. doi: 10.4088/JCP.23m14883.

  PMID: 38019593 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Heart Arrest

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Yuval Neria
• Organization: New York State Psychiatric Institute

ny126@cumc.columbia.edu

646-774-8092

Study Officials

• Yuval Neria, PhD

  Columbia University and NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Psychology

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: March 2, 2021
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-04

Locations

US (1)