PTSDAMBETNCT04596891
Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
A study testing Psychotherapy in people with PTSD and Cardiac Arrest, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PTSD, Cardiac Arrest
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 21 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Feasibility Pilot of Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
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.
Read the detailed description
Clinically elevated levels of PTSD symptoms occur in approximately 1 in 3 cardiac arrest survivors with intact cognitive function and are associated with increased risk for future cardiac events and mortality. Survivors of acute cardiovascular events are typically encouraged to monitor for somatic cues of cardiovascular activity that might indicate recurrent events. However, threat-related attention bias is a common sequela of trauma. In cardiac patients, this hypervigilant attention to interoceptive cues of danger may serve to maintain threat perception, as arousal amplifies awareness of internal stimuli. Elevated PTSD symptoms have also been associated with low adherence to physical activity and medication regiments in patients with elevated PTSD symptoms after other types of cardiovascular events in part because they can serve as traumatic reminders. Although several well-studied, validated treatments for PTSD exist, there is no evidence-based treatment for PTSD in cardiac arrest survivors. Standard PTSD interventions targeting fear extinction and threat perception in the context of current safety pose a problem in a population that is living with an actual ongoing cardiac threat. Thus, the investigators will be developing a de novo protocol for an Acceptance and Mindfulness-Based Exposure Therapy (AMBET) intervention that targets increased discriminatory perception through mindful interoceptive attention and adaptive threat responding. Initial evidence has been published to suggest the safety and potential efficacy of imaginal exposure in cardiac patients to reduce PTSD symptoms. Among PTSD treatments, exposure therapy is the most widely recommended. However, the efficacy is moderate, and high dropout rates are well documented. An innovative line of PTSD therapies can be found among mindfulness- and acceptance-based treatments. Although large scale RCTs are still limited, there are promising findings of treatment effects on reduced PTSD symptoms. Reported dropout rates have been low across treatments, indicating a high degree of treatment acceptability. The addition of mindfulness components to exposure therapy has been proposed to enhance the effects of exposure as well as the willingness to engage in them. Of particular interest for cardiac patients are findings that mindfulness-based approaches have normalized cortisol levels and reduced inflammatory biomarkers in PTSD patients, as these are physiological processes that have been implicated in the links between PTSD and cardiovascular risk. Several mechanisms have been posited to underlie the efficacy of mindfulness-based approaches including increased metacognitive awareness of interoceptive sensations and mind-body connections. Furthermore, and contrary to the associations found between hypervigilant interoceptive awareness and psychopathology, mindful attention to interoceptive cues has been linked with adaptive, resilience-enhancing behaviors. The goals of the AMBET treatment will be to reduce PSTD symptoms and hypervigilance to internal stimuli (i.e., interoceptive bias), and increase cardiovascular health behaviors (medication adherence, physical activity) following cardiac arrest. Following psychoeducation about PTSD and cardiovascular disease related health behaviors, participants will be engaged in in-vivo and imaginal exposure exercises to reduce avoidance responses. Participants will be introduced to acceptance and mindfulness-based strategies that will be practiced in session and as homework assignments. Eight 90 minute sessions will be delivered to patients individually on a weekly basis through HIPAA-compliant zoom-hosted video visits. Patient symptoms will be assessed by an independent evaluator before, at mid-point, and post-treatment. A within-subjects repeated measures design will be used to assess the feasibility of conducting all aspects of the study remotely, including recruitment, assessment, and treatment delivery.
- Conditions
- PTSD, Cardiac Arrest
- Being tested
- Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Remotely delivered psychotherapy combining exposure therapy with mindfulness Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: End of treatment: approximately 3 months from intake
Secondary outcomes (5)
Participant Satisfaction With Treatment
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.
Measured: End of treatment: approximately 3 months from intake
Proportion of Participants Who Complete the Study Protocol
Preliminary tolerability of the protocol will assessed by the number of enrolled participants who comply with all study procedures
Measured: End of treatment: approximately 3 months from intake
Change in Depressive Symptoms Over Time
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).
Measured: At Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake
Change in Interoceptive Attention Style Over Time
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 (increased adaptive interoceptive attention).
Measured: Baseline, Post-treatment: approximately 3 months from intake
Change in Cardiac Anxiety
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).
Measured: Baseline, Post-treatment: approximately 3 months from intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start2 Mar 2021
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Yuval Neria, PhD, Principal investigator, Columbia University and NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596891
- Sponsor's protocol ID
- 8017
- Acronym
- AMBET
- Status last verified
- Apr 2025
- First submitted
- 15 Oct 2020
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38019593
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot of Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04596891
- Acronym / sponsor ID
- AMBET / 8017
- Conditions
- PTSD, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Columbia University
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clinically elevated levels of PTSD symptoms occur in approximately 1 in 3 cardiac arrest survivors with intact cognitive function and are associated with increased risk for future cardiac events and mortality. Survivors of acute cardiovascular events are typically encouraged to monitor for somatic cues of cardiovascular activity that might indicate recurrent events. However, threat-related attention bias is a common sequela of trauma. In cardiac patients, this hypervigilant attention to interoceptive cues of danger may serve to maintain threat perception, as arousal amplifies awareness of internal stimuli. Elevated PTSD symptoms have also been associated with low adherence to physical activity and medication regiments in patients with elevated PTSD symptoms after other types of cardiovascular events in part because they can serve as traumatic reminders. Although several well-studied, validated treatments for PTSD exist, there is no evidence-based treatment for PTSD in cardiac arrest survivors. Standard PTSD interventions targeting fear extinction and threat perception in the context of current safety pose a problem in a population that is living with an actual ongoing cardiac threat. Thus, the investigators will be developing a de novo protocol for an Acceptance and Mindfulness-Based Exposure Therapy (AMBET) intervention that targets increased discriminatory perception through mindful interoceptive attention and adaptive threat responding. Initial evidence has been published to suggest the safety and potential efficacy of imaginal exposure in cardiac patients to reduce PTSD symptoms. Among PTSD treatments, exposure therapy is the most widely recommended. However, the efficacy is moderate, and high dropout rates are well documented. An innovative line of PTSD therapies can be found among mindfulness- and acceptance-based treatments. Although large scale RCTs are still limited, there are promising findings of treatment effects on reduced PTSD symptoms. Reported dropout rates have been low across treatments, indicating a high degree of treatment acceptability. The addition of mindfulness components to exposure therapy has been proposed to enhance the effects of exposure as well as the willingness to engage in them. Of particular interest for cardiac patients are findings that mindfulness-based approaches have normalized cortisol levels and reduced inflammatory biomarkers in PTSD patients, as these are physiological processes that have been implicated in the links between PTSD and cardiovascular risk. Several mechanisms have been posited to underlie the efficacy of mindfulness-based approaches including increased metacognitive awareness of interoceptive sensations and mind-body connections. Furthermore, and contrary to the associations found between hypervigilant interoceptive awareness and psychopathology, mindful attention to interoceptive cues has been linked with adaptive, resilience-enhancing behaviors. The goals of the AMBET treatment will be to reduce PSTD symptoms and hypervigilance to internal stimuli (i.e., interoceptive bias), and increase cardiovascular health behaviors (medication adherence, physical activity) following cardiac arrest. Following psychoeducation about PTSD and cardiovascular disease related health behaviors, participants will be engaged in in-vivo and imaginal exposure exercises to reduce avoidance responses. Participants will be introduced to acceptance and mindfulness-based strategies that will be practiced in session and as homework assignments. Eight 90 minute sessions will be delivered to patients individually on a weekly basis through HIPAA-compliant zoom-hosted video visits. Patient symptoms will be assessed by an independent evaluator before, at mid-point, and post-treatment. A within-subjects repeated measures design will be used to assess the feasibility of conducting all aspects of the study remotely, including recruitment, assessment, and treatment delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: PsychotherapyRemotely delivered psychotherapy combining exposure therapy with mindfulness |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyEight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform. | Behavioural | Intervention |
Primary outcome
Change in PTSD Symptoms Over Time
Time frame: 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).
Change in Medication Adherence Over Time
Time frame: 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.
Change in Physical Activity Over Time
Time frame: End of treatment: approximately 3 months from intake
Participants level of physical activity is measured objectively by a wrist worn Fitbit device.
5 secondary outcomes
Participant Satisfaction With Treatment
Time frame: End of treatment: approximately 3 months from intake
Proportion of Participants Who Complete the Study Protocol
Time frame: End of treatment: approximately 3 months from intake
Change in Depressive Symptoms Over Time
Time frame: At Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake
Change in Interoceptive Attention Style Over Time
Time frame: Baseline, Post-treatment: approximately 3 months from intake
Change in Cardiac Anxiety
Time frame: Baseline, Post-treatment: approximately 3 months from intake
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38019593Bergman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuval Neria, PhD principal investigator
Columbia University and NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with PTSD and Cardiac Arrest, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptoms Over Time (time frame: Baseline, At 4 weeks, Post-treatment: approximately 3 months from intake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.