Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest (AMBET)

• ClinicalTrials.gov Identifier: NCT04596891
• Recruitment Status: Completed
• First Posted: October 22, 2020
• Last Update Posted: May 26, 2022
• Sponsor: Research Foundation for Mental Hygiene, Inc.
• Collaborator: Columbia University
• Information provided by (Responsible Party): Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PTSD; Cardiac Arrest	Behavioral: Psychotherapy	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Pilot of Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
• Actual Study Start Date: March 2, 2021
• Actual Primary Completion Date: April 21, 2022
• Actual Study Completion Date: April 21, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Remotely delivered psychotherapy combining exposure therapy with mindfulness	Behavioral: Psychotherapy; Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.

Outcome Measures

Primary Outcome Measures :

1. 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 scored mean better outcome
2. 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.
3. 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.

Secondary Outcome Measures :

1. Participant satisfaction with treatment [ Time Frame: End of treatment: approximately 3 months from intake ]
   Treatment satisfaction will be measured by the Client Satisfaction Questionnaire (CSQ-3)
2. Proportion of participants who complete the study protocol [ Time Frame: 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
3. Change in depressive symptoms over time [ Time Frame: 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.
4. Change in interoceptive attention style over time [ Time Frame: 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).
5. Change in cardiac anxiety [ Time Frame: 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). Lowe scores mean better outcome

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Heart failure with severe systolic dysfunction (ejection fraction ≤ 25%)
2. Terminal non-cardiovascular illness with life expectancy <1 year
3. History of psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder
4. 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.
5. Significant cognitive impairment defined by Cerebral Performance Category Score ≥3, and/or MMSE score of <24 neurological impairment precluding ability to complete study questionnaires.
6. Active suicidal ideation or behavior.
7. Current primary diagnosis of bipolar disorder.
8. Current unstable or untreated medical illness.
9. Current drug or alcohol misuse: severe alcohol/cannabis or any other substance use disorder (except nicotine).
10. Recent psychotropic medication change or initiation within the last 3 months.
11. Initiation of other psychotherapy within the last 3 months.

Contacts and Locations

Locations

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032

Sponsors and Collaborators

Research Foundation for Mental Hygiene, Inc.

Columbia University

More Information

• Responsible Party: Yuval Y Neria, Professor of Medical Psychology, Research Foundation for Mental Hygiene, Inc.
• ClinicalTrials.gov Identifier: NCT04596891
• Other Study ID Numbers: 8017
• First Posted: October 22, 2020
• Last Update Posted: May 26, 2022
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Arrest; Heart Diseases; Cardiovascular Diseases