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

• ClinicalTrials.gov Identifier: NCT04582396
• Recruitment Status: Terminated
• First Posted: October 9, 2020
• Last Update Posted: April 26, 2022
• Sponsor: Columbia University
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Sachin Agarwal, Columbia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PTSD; Cardiac Arrest; Anxiety and Fear; Sleep Disturbance; Health Behavior	Procedure: stellate ganglion block injection; Procedure: Normal saline injection; Behavioral: Psychoeducation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a pilot RCT to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade and psychoeducation vs sham-procedure and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: In addition to the unblinded coordinator, and due to the nature of the study treatment, the person performing the procedure cannot be blinded (i.e. the person performing the procedure needs to assess the effectiveness of the block objective physical signs and symptoms), but is encouraged not to disclose the allocation to the patient or outcome assessors either before or after the procedure.
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Stellate Ganglion Blockade + Psychoeducation to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
• Actual Study Start Date: March 11, 2021
• Actual Primary Completion Date: April 19, 2021
• Actual Study Completion Date: April 19, 2021

Arms and Interventions

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 Name: 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.	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 Name: Sham procedure; 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

Outcome Measures

Primary Outcome Measures :

1. Proportion of eligible subjects who get enrolled in the trial [ Time Frame: Baseline (pre-procedure) ]
   This is designed to measure the feasibility of successful enrollment.
2. Number of patients recruited per month [ Time Frame: 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
3. Proportion of participants who complete the 4-weeks assessments [ Time Frame: Study Completion (Approximately 11 months) ]
   This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.
4. Proportion of participants who complete the 12-weeks assessments [ Time Frame: Assessed at 12-weeks post-procedure ]
   This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.
5. Proportion of participants who develop one or more signs of Horner's syndrome [ Time Frame: Assessed at baseline post-procedure ]
   Horner's syndrome density grading scale will be used to assess treatment fidelity
6. Treatment expectancy questionnaire [ Time Frame: Assessed at baseline, post-procedure ]
   Treatment credibility will be assessed.
7. The proportion of participants completing the check-list of various components of Psychoeducation [ Time Frame: 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.
8. The proportion of participants with >80% of the total actigraph wear time [ Time Frame: Assessed at 4-weeks post-procedure ]
   It is designed to assess the acceptability of actigraphy

Secondary Outcome Measures :

1. The proportion of participants with clinically significant symptoms of Posttraumatic Stress Disorder (PCL-5) [ Time Frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure ]
   The Effect of SGB-PsychoED intervention on PTSD symptoms will be assessed using PCL-5.
2. The proportion of participants with clinically significant symptoms of Cardiac anxiety [ Time Frame: 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)
3. The proportion of participants with clinically significant symptoms of Generalized anxiety disorder. [ Time Frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure ]
   The effect of SGB-PsychoED intervention on generalized anxiety disorder will be assessed using generalized anxiety disorder scale-7 (GAD-7)
4. The proportion of participants with clinically significant symptoms of depression. [ Time Frame: 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).
5. The proportion of participants with moderate to high levels of physical activity. [ Time Frame: 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
6. The proportion of participants with reduced duration of sleep. [ Time Frame: Assessed at 4-weeks post-discharge ]
   Effect of SGB-PsychoED intervention on mean hours/day of sleep as measured by the objective actigraphy data

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. 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

Contacts and Locations

Locations

United States, New York

Columbia University Medical Center/New York Presbyterian

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

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

More Information

• Responsible Party: Sachin Agarwal, Assistant Professor of Neurology, Department of Neurology, Columbia University
• ClinicalTrials.gov Identifier: NCT04582396
• Other Study ID Numbers: AAAS8305; 5P30AG064198-02 ( U.S. NIH Grant/Contract )
• First Posted: October 9, 2020
• Last Update Posted: April 26, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

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

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

Additional relevant MeSH terms:

Dyssomnias; Parasomnias; Heart Arrest; Anxiety Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Sleep Wake Disorders; Nervous System Diseases