This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA). Primary Aim 1 (Feasibility outcomes): Gain preliminary evidence regarding the acceptability, tolerability, and safety of conducting a randomized trial that evaluates a single SGB treatment in conjunction with psychoeducation among CA patients with early PTSD symptoms. Secondary Aim 1 (Treatment-related outcomes): Test, whether SGB/psychoeducation treatment in CA patients with clinically significant PTSD symptoms is associated with reduced cardiac anxiety, PTSD symptoms, and improved health behaviors (physical activity and sleep duration), assessed objectively by a wrist-worn accelerometer for 4 weeks post-discharge.
Every year in the U.S., 500,000 people experience sudden cardiac arrest (CA), caused by electrical disturbances across cardiac tissue, leading to marked arrhythmia that ultimately results in the heart ceasing to pump blood to the brain, lungs, and other organs. Due to advances in bundled post-arrest care, cardio-cerebral resuscitation, and effective cooling protocols, a substantial proportion of patients who receive guideline-based care (nearly 1 in 3 for out-of-hospital and \~50% for in-hospital CA) now survive this once universally fatal condition. While most survivors retain their cognitive function and physical independence, many grapple with CA's psychological consequences in the context of learning that they were "clinically dead." In particular, many describe the CA experience as traumatic, and up to 1 in 3 CA survivors subsequently develop posttraumatic stress disorder (PTSD). Not only is PTSD common in CA patients, but there is evidence that PTSD after CA may influence health behaviors and prognosis. Treatment of early PTSD and cardiac anxiety symptoms after CA requires timely intervention. Recent studies show that SGB is a safe and acceptable intervention for reducing PTSD symptoms in combat veterans. SGB treatment has never been tested to treat PTSD induced by acute medical events such as CA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
A stellate ganglion block (SGB) is an injection of local anesthetic (numbing medicine) to block the nerves located on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.
An injection of normal saline will be injected into muscle on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.
The session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior. Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA
Columbia University Medical Center/New York Presbyterian
New York, New York, United States
Proportion of Eligible Subjects Who Get Enrolled in the Trial
This is designed to measure the feasibility of successful enrollment.
Time frame: Baseline (pre-procedure)
Number of Patients Recruited Per Month
This is designed to measure the rate of enrollment, with \<4 patients/month considered not meeting outcome
Time frame: Assessed at 10 Month from the beginning of enrollment
Proportion of Participants Who Complete the 4-weeks Assessments
This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.
Time frame: 4 weeks post-enrollment
Proportion of Participants Who Complete the 12-weeks Assessments
This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.
Time frame: 12-weeks post-procedure
Horner's Syndrome
Horner syndrome is a condition that affects the face and eye on one side of the body, being caused by a disrupted nerve pathway from the brain to the head and neck. This syndrome can be assessed through a visual exam, involving the observation of decreased pupil size, a drooping eyelid and decreased sweating on the affected side of the face.
Time frame: Immediately post-procedure
Treatment Expectancy Eligibility Questionnaire
This is a questionnaire that assesses the number of participants with credibility. Through this questionnaire, whether the participant will proceed through the study will be determined.
Time frame: Immediately post-procedure
The Proportion of Participants Completing the Check-list of Various Components of Psychoeducation
This is designed to assess the feasibility of administering psychoeducation, with \>80% of the components in the checklist as a threshold for success.
Time frame: Assessed at baseline post-procedure
Total Actigraph Wear Time
the proportion of participants with \>80% of the total actigraph wear time. It is designed to assess the acceptability of actigraphy
Time frame: Assessed at 4-weeks post-procedure
Number of Participants With Posttraumatic Stress Disorder Using Posttraumatic Stress Disorder (PCL-5)
This is a 20-item self-report measure that assesses symptoms of PTSD. Each item can be scored on a scale of 0-4, "Not at all" (0), "A little bit" (1), "Moderately" (2), "Quite a bit" (3), and "Extremely" (4) are the eligible responses. There are five clusters that are assessed: items 1-5, items 6-7, items 8-14, and items 15-20. Each of these sub-scores are summed to receive a score between 0-80; a higher score indicating a higher severity of PTSD symptoms. The cutoff score that is indicative of probable PTSD is 31-33.
Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Cardiac Anxiety
The effect of SGB-PsychoED intervention on cardiac anxiety will be assessed using cardiac anxiety questionnaire (CAQ).This is an 18-item questionnaire that assesses anxiety through three divided sub-scales: fear (items 10, 11, 13-18), avoidance (items 2, 5, 7, 9, 12), and attention (items 1, 3, 4, 6, 8). Each item is scored via the 5-point Likert scale: "Never" (0), "Rarely" (1). "Sometimes" (2), "Often" (3), and "Always" (4). Item responses are summed to receive a score between 0-72. Higher reported scores indicate a greater heart-focused anxiety.
Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Generalized Anxiety Disorder.
The effect of the intervention on generalized anxiety disorder will be assessed using the generalized anxiety disorder scale-7 (GAD-7). This is a 7-item scale that assesses the presence of generalized anxiety disorder. Responses can be given as "Not at all" (0), "Several days" (1), "More than half the days" (2), and "Nearly every day" (3). These scores can be summed to produce a score between 0 and 21. Scores between 0-4 indicate minimal anxiety, scores between 5-9 indicate mild anxiety, scores between 10-14 indicate moderate anxiety, and scores greater than 15 indicate severe anxiety.
Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Depression.
The effect of SGB-PsychoED intervention on depression will be assessed using the eight-item Patient Health Questionnaire depression scale (PHQ-8). This is an 8-item scale that assesses depression, with responses to each item being: "Not at all" (0), "Several days" (1), "More than half the days" (2), and "Nearly every day" (3). The sub-scores are summed to result in a score from 0-24. Higher scores indicate higher indication of depression. Scores that are reported as 10 or above are assessed to be showing symptoms of depression.
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Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Moderate to High Levels of Physical Activity.
Effect of SGB-PsychoED intervention on mean minutes/day of physical activity as measured by the objective actigraphy data
Time frame: Assessed at 4-weeks post-discharge
The Proportion of Participants With Reduced Duration of Sleep.
Effect of SGB-PsychoED intervention on mean hours/day of sleep as measured by the objective actigraphy data
Time frame: Assessed at 4-weeks post-discharge