NCT04596891: AMBET

Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest

Completed NA Results posted Last updated 8 April 2025

What this trial tests

NA trial testing Psychotherapy in PTSD in 11 participants. Completed in 21 April 2022.

Timeline

2 March 2021

Primary endpoint
21 April 2022

21 April 2022

Quick facts

Lead sponsor	Research Foundation for Mental Hygiene, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	2 March 2021
Primary completion	21 April 2022
Estimated completion	21 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Psychotherapy

Conditions studied

• PTSD — all drugs for PTSD →
• Cardiac Arrest — all drugs for Cardiac Arrest →

Sponsor

Research Foundation for Mental Hygiene, Inc.

Who can join

Adults 18 to 85, any sex, with PTSD or Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in PTSD Symptoms Over Time Primary · Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake

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

Group	Value	95% CI
Intervention	37.00	± 7.05

Midpoint (4 weeks)

Group	Value	95% CI
Intervention	25.90	± 9.15

Posttreatment

Group	Value	95% CI
Intervention	16.20	± 10.84

Change in Medication Adherence Over Time Primary · End of treatment: approximately 3 months from intake

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.

Baseline

Group	Value	95% CI
Intervention	3.18	± 1.83

Posttreatment

Group	Value	95% CI
Intervention	2.38	± 1.41

Change in Physical Activity Over Time Primary · End of treatment: approximately 3 months from intake

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

Baseline

Group	Value	95% CI
Intervention	7109.83	± 5377.75

Posttreatment

Group	Value	95% CI
Intervention	9296.83	± 5600.44

Participant Satisfaction With Treatment Secondary · End of treatment: approximately 3 months from intake

Treatment satisfaction will be measured by the Client Satisfaction Questionnaire (CSQ-3). Scores range from 0-12 with higher scores indication more satisfaction with treatment.

Group	Value	95% CI
Intervention	10.9	± 1.3

Proportion of Participants Who Complete the Study Protocol Secondary · End of treatment: approximately 3 months from intake

Preliminary tolerability of the protocol will assessed by the number of enrolled participants who comply with all study procedures

Group	Value	95% CI
Intervention	10

Change in Depressive Symptoms Over Time Secondary · At Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake

Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-17; range 0-52) from pre- to post-treatment. Lower scores indicate better outcomes (reduction in symptoms).

Baseline

Group	Value	95% CI
Intervention	17.27	± 6.36

Midpoint (4 weeks)

Group	Value	95% CI
Intervention	13.50	± 4.50

Posttreatment

Group	Value	95% CI
Intervention	10.10	± 7.23

Change in Interoceptive Attention Style Over Time Secondary · Baseline, Post-treatment: approximately 3 months from intake

Changes in hypervigilance driven interoceptive attention and acceptance/mindfulness-based attention will be measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA). The scale consists of 8 scales (addressing 5 dimensions of body awareness)The MAIA consists of 8 scales (addressing 5 dimensions of body awareness): Noticing (0-20); Not-Distracting (0-30); Not-Worrying (0-25); Attention Regulation (0-35); Emotional Awareness (0-25); Self-Regulation (0-20); Body Listening (0-15); Trust (0-15). A total scale score is not relevant. Higher scores indicate better outcomes (increas

Baseline: Noticing Subscale

Group	Value	95% CI
Intervention	10.73	± 3.13

Posttreatment: Noticing Subscale

Group	Value	95% CI
Intervention	11.56	± 3.57

Baseline: Not Distracting Subscale

Group	Value	95% CI
Intervention	12.63	± 5.30

Posttreatment: Not Distracting Subscale

Group	Value	95% CI
Intervention	10.22	± 4.29

Baseline: Not Worrying Subscale

Group	Value	95% CI
Intervention	9.81	± 2.18

Posttreatment: Not Worrying Subscale

Group	Value	95% CI
Intervention	8.56	± 2.79

Baseline: Attention Regulation Subscale

Group	Value	95% CI
Intervention	15.73	± 4.88

Posttreatment: Attention Regulation Subscale

Group	Value	95% CI
Intervention	15.67	± 4.15

Change in Cardiac Anxiety Secondary · Baseline, Post-treatment: approximately 3 months from intake

Change in cardiac anxiety from pre- to post-treatment assessment will be assessed using the Cardiac Anxiety Questionnaire (CAQ: score range: 0-72). Low scores mean better outcome (reduction in cardiac anxiety).

Baseline

Group	Value	95% CI
Intervention	36.67	± 9.67

Posttreatment

Group	Value	95% CI
Intervention	35.00	± 10.39

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychological Distress After Sudden Cardiac Arrest and Its Impact on Recovery.
   Agarwal S, Birk JL, Abukhadra SL, Rojas DA, et al · · 2022 · cited 28× · PMID 35921024 · DOI 10.1007/s11886-022-01747-9
2. Psychological and behavioral dimensions in cardiac arrest survivors and their families: A state-of-the-art review.
   Agarwal S, Wagner MK, Mion M. · · 2025 · cited 7× · PMID 39709245 · DOI 10.1016/j.neurot.2024.e00509
3. Acceptance and Mindfulness-Based Exposure Therapy for PTSD After Cardiac Arrest: An Open Feasibility Trial.
   Bergman M, Markowitz JC, Kronish IM, Agarwal S, et al · · 2023 · cited 6× · PMID 38019593 · DOI 10.4088/jcp.23m14883