Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors

Not Applicable

Terminated

Conditions: PTSD
Anxiety and Fear
Sleep Disturbance
Cardiac Arrest
Health Behavior

Interventions: Procedure: stellate ganglion block injection
Procedure: Normal saline injection
Behavioral: Psychoeducation

Registration Number: NCT04582396

Lead Sponsor: Columbia University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellate Ganglion Block + Psychoeducation	Psychoeducation	For the active SGB arm, 7 to 8 mL of ropivacaine, 0.5%, will be injected around and into the site of the ganglion once before the hospital discharge. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.
Stellate Ganglion Block + Psychoeducation	stellate ganglion block injection	For the active SGB arm, 7 to 8 mL of ropivacaine, 0.5%, will be injected around and into the site of the ganglion once before the hospital discharge. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.
Normal saline injection + Psychoeducation	Normal saline injection	For the sham procedure, 1 to 2 mL of preservative-free normal saline will be injected into deep musculature in the neck. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.
Normal saline injection + Psychoeducation	Psychoeducation	For the sham procedure, 1 to 2 mL of preservative-free normal saline will be injected into deep musculature in the neck. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Who Complete the 12-weeks Assessments	12-weeks post-procedure	This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.
Treatment Expectancy Eligibility Questionnaire	Immediately post-procedure	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.
Proportion of Eligible Subjects Who Get Enrolled in the Trial	Baseline (pre-procedure)	This is designed to measure the feasibility of successful enrollment.
Number of Patients Recruited Per Month	Assessed at 10 Month from the beginning of enrollment	This is designed to measure the rate of enrollment, with \<4 patients/month considered not meeting outcome
Proportion of Participants Who Complete the 4-weeks Assessments	4 weeks post-enrollment	This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.
Horner's Syndrome	Immediately post-procedure	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.
The Proportion of Participants Completing the Check-list of Various Components of Psychoeducation	Assessed at baseline post-procedure	This is designed to assess the feasibility of administering psychoeducation, with \>80% of the components in the checklist as a threshold for success.
Total Actigraph Wear Time	Assessed at 4-weeks post-procedure	the proportion of participants with \>80% of the total actigraph wear time. It is designed to assess the acceptability of actigraphy

Secondary Outcome Measures

Name	Time	Method
The Proportion of Participants With Moderate to High Levels of Physical Activity.	Assessed at 4-weeks post-discharge	Effect of SGB-PsychoED intervention on mean minutes/day of physical activity as measured by the objective actigraphy data
The Proportion of Participants With Clinically Significant Symptoms of Depression.	Assessed pre-procedure and then repeated at 4-weeks post-procedure	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.
The Proportion of Participants With Clinically Significant Symptoms of Cardiac Anxiety	Assessed pre-procedure and then repeated at 4-weeks post-procedure	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.
The Proportion of Participants With Reduced Duration of Sleep.	Assessed at 4-weeks post-discharge	Effect of SGB-PsychoED intervention on mean hours/day of sleep as measured by the objective actigraphy data
The Proportion of Participants With Clinically Significant Symptoms of Generalized Anxiety Disorder.	Assessed pre-procedure and then repeated at 4-weeks post-procedure	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.
Number of Participants With Posttraumatic Stress Disorder Using Posttraumatic Stress Disorder (PCL-5)	Assessed pre-procedure and then repeated at 4-weeks post-procedure	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.