Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors (SGB-PsychoED)

A Pilot Study of Stellate Ganglion Blockade + Psychoeducation to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors

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.

Study Overview

• Status: Terminated
• Conditions: PTSD; Sleep Disturbance; Cardiac Arrest; Health Behavior; Anxiety and Fear
• Intervention / Treatment: Procedure: stellate ganglion block injection; Behavioral: Psychoeducation; Procedure: Normal saline injection

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

1. Age 18 years or older
2. Fluent in English or Spanish
3. A diagnosis of cardiac arrest (CA)
4. Admitted to the New York-Presbyterian Hospital
5. Elevated symptoms of psychological distress a. PCL-5 > 32 with a minimum of 2 weeks after cardiac arrest

Exclusion criteria

1. A prior SGB treatment
2. Severe brain injury defined as Cerebral Performance Category Score ≥3, and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer
3. Terminal non-cardiovascular illness (life expectancy <1 year)
4. Severe mental illness requiring urgent psychiatric hospitalization
5. Alcohol or substance abuse that would impede ability to complete study
6. Unavailable for telephone and in-person follow-up
7. Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
8. Pre-existing Horner's syndrome
9. Pregnancy
10. Current anticoagulant use
11. History of a bleeding disorder
12. Infection or mass at injection site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stellate Ganglion Block + 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.	Procedure: stellate ganglion block injection; 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.; Other Names: SGB injection; Behavioral: Psychoeducation; 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
Placebo Comparator: Normal saline injection + 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.	Behavioral: Psychoeducation; 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; Procedure: Normal saline injection; 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.; Other Names: Sham procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible subjects who get enrolled in the trial	This is designed to measure the feasibility of successful enrollment.	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	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.	Study Completion (Approximately 11 months)
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.	Assessed at 12-weeks post-procedure
Proportion of participants who develop one or more signs of Horner's syndrome	Horner's syndrome density grading scale will be used to assess treatment fidelity	Assessed at baseline post-procedure
Treatment expectancy questionnaire	Treatment credibility will be assessed.	Assessed at baseline, 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.	Assessed at baseline post-procedure
The proportion of participants with >80% of the total actigraph wear time	It is designed to assess the acceptability of actigraphy	Assessed at 4-weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with clinically significant symptoms of Posttraumatic Stress Disorder (PCL-5)	The Effect of SGB-PsychoED intervention on PTSD symptoms will be assessed using PCL-5.	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)	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 SGB-PsychoED intervention on generalized anxiety disorder will be assessed using generalized anxiety disorder scale-7 (GAD-7)	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).	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	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	Assessed at 4-weeks post-discharge

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sachin Agarwal, MD, MPH, Columbia University/New York Presbyterian; Study Director: Ian M Kronish, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): April 19, 2021
• Study Completion (Actual): April 19, 2021

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Sleep Wake Disorders; Anxiety Disorders; Dyssomnias; Parasomnias; Heart Arrest
• Other Study ID Numbers: AAAS8305; 5P30AG064198-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified data will be made available upon request to the study principal investigator.
• IPD Sharing Time Frame: Data will become available on August 1, 2021, and will be available until August 1, 2025.
• IPD Sharing Access Criteria: For whom: Researchers who provide a methodologically sound protocol. For what analyses: To achieve aims in the approved protocol.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No