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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG064198-02 | U.S. NIH Grant/Contract | View source |
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majority of the participants had exclusion criteria of anticoagulant use
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate Ganglion Block + Psychoeducation | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stellate ganglion block injection | Procedure | 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. |
| 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. | 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. | 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. | 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. | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sachin Agarwal, MD, MPH | Columbia University/New York Presbyterian | Principal Investigator |
| Ian M Kronish, MD, MPH | Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center/New York Presbyterian | New York | New York | 10032 | United States |
De-identified data will be made available upon request to the study principal investigator.
Data will become available on August 1, 2021, and will be available until August 1, 2025.
For whom: Researchers who provide a methodologically sound protocol. For what analyses: To achieve aims in the approved protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2021 |
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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.
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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.
|
| Normal saline injection | Procedure | 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. |
|
|
| Psychoeducation | Behavioral | 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 |
|
| 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 |
| 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 | Assessed at 4-weeks post-procedure |
| 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. | 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. | 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. | 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 |
| FG001 | 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. 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. 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
No accrued participants were randomized to the Stellate Ganglion Block + Psychoeducation Group
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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 |
| BG001 | 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. 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. 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Posttraumatic Stress Disorder Scale | 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. | Number | units on a scale |
| |||||||||||||||||
| Cardiac Anxiety Questionnaire | 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. | Number | units on a scale |
| |||||||||||||||||
| Generalized Anxiety Disorder Scale - 7 questions | 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 | units on a scale |
| |||||||||||||||||
| Patient Health Questionnaire depression scale- 8 items | 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. | Number | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Eligible Subjects Who Get Enrolled in the Trial | This is designed to measure the feasibility of successful enrollment. | During the enrollment period, 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, 10 were prescribed anticoagulants, rendering them ineligible for the study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Baseline (pre-procedure) |
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| Primary | Number of Patients Recruited Per Month | This is designed to measure the rate of enrollment, with <4 patients/month considered not meeting outcome | During the enrollment period, 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, 10 were prescribed anticoagulants, rendering them ineligible for the study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Assessed at 10 Month from the beginning of enrollment |
| ||||||||||||||||||||||||||||
| Primary | 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. | There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm | Posted | Count of Participants | Participants | 4 weeks post-enrollment |
| ||||||||||||||||||||||||||||
| Primary | 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. | There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm | Posted | Count of Participants | Participants | 12-weeks post-procedure |
| ||||||||||||||||||||||||||||
| Primary | 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. | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, 10 were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Immediately post-procedure |
| ||||||||||||||||||||||||||||
| Primary | 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. | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Immediately post-procedure |
| ||||||||||||||||||||||||||||
| Primary | 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. | There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm | Posted | Count of Participants | Participants | Assessed at baseline post-procedure |
| ||||||||||||||||||||||||||||
| Primary | 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 | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Assessed at 4-weeks post-procedure |
| ||||||||||||||||||||||||||||
| Secondary | 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. | There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm | Posted | Count of Participants | Participants | Assessed pre-procedure and then repeated at 4-weeks post-procedure |
| ||||||||||||||||||||||||||||
| Secondary | 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. | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Assessed pre-procedure and then repeated at 4-weeks post-procedure |
| ||||||||||||||||||||||||||||
| Secondary | 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. | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Assessed pre-procedure and then repeated at 4-weeks post-procedure |
| ||||||||||||||||||||||||||||
| Secondary | 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. | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Assessed pre-procedure and then repeated at 4-weeks post-procedure |
| ||||||||||||||||||||||||||||
| Secondary | 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 | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Assessed at 4-weeks post-discharge |
| ||||||||||||||||||||||||||||
| Secondary | 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 | 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures. | Posted | Count of Participants | Participants | Assessed at 4-weeks post-discharge |
|
Adverse Event Data were collected for 4 weeks after the intervention was administered
Study personnel received alerts whenever a study participant was admitted to NYP Hospital/CUIMC
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. 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. 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 | 0 | 1 | 0 | 1 | 1 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room visit | Gastrointestinal disorders | Systematic Assessment | Emergency Department visit unrelated to the study, satisfactorily resolved without an inpatient admission. The study team was not required to take any further action. |
|
The study did not reach the target enrollment and therefore was inconclusive for treatment-related outcomes. This would need to be addressed in a future study in an outpatient setting because we learned that a majority of the inpatients were prescribed anticoagulants while in the hospital, which rendered them ineligible for the study.
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sachin Agarwal | Columbia University | 2123421335 | sa2512@cumc.columbia.edu |
| Jun 2, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2021 | Sep 9, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D006323 | Heart Arrest |
| D001008 | Anxiety Disorders |
| D020447 | Parasomnias |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| >=65 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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