Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
Condition: PTSD; Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

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.
    

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.
    

Intervention name(s): Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment