N/A
N=11
Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
PTSD · Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT04596891 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in PTSD Symptoms Over Time — 37.00; 25.90; 16.20 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychotherapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Research Foundation for Mental Hygiene, Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Symptoms Over Time |
37.00; 25.90; 16.20 | <0.001 sig |
| PRIMARY Change in Medication Adherence Over Time |
3.18; 2.38 | — |
| PRIMARY Change in Physical Activity Over Time |
7109.83; 9296.83 | — |
| SECONDARY Participant Satisfaction With Treatment |
10.9 | — |
| SECONDARY Proportion of Participants Who Complete the Study Protocol |
10 | — |
| SECONDARY Change in Depressive Symptoms Over Time |
17.27; 13.50; 10.10 | <0.001 sig |
| SECONDARY Change in Interoceptive Attention Style Over Time |
10.73; 11.56; 12.63; 10.22; 9.81; 8.56 | — |
| SECONDARY Change in Cardiac Anxiety |
36.67; 35.00 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04596891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.