Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest (NCT04596891) | Clinical Trial Compass
CompletedNot Applicable
Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
United States11 participantsStarted 2021-03-02
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PTSD Symptoms Over Time
Timeframe: Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake
2
Change in Medication Adherence Over Time
Timeframe: End of treatment: approximately 3 months from intake
3
Change in Physical Activity Over Time
Timeframe: End of treatment: approximately 3 months from intake
Trial details
NCT IDNCT04596891
SponsorResearch Foundation for Mental Hygiene, Inc.
. 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.