Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room

Study Overview
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Brief Summary
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The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption.

Detailed Description
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The goal of this research is to compare the benefits and risks of three anxiety treatments that are pragmatic, graduated in the level of resource intensity, and have demonstrated efficacy and feasibility for real world adoption. Low-risk (non-cardiac) chest pain patients with anxiety will be recruited to participate in the study using the SBIRT (screening, brief intervention, and referral to treatment) model and enrolled participants will be randomly assigned to one of three treatment arms: 1) referral to primary care with enhanced care coordinated (low intensity); 2) online CBT with support from a certified peer recovery specialist (medium intensity); and 3) therapist-led CBT via tele-health (high intensity). We expect improved symptoms and functional capacity, reduced ED return visits, and heterogenous treatment effects.

Official Title
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Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room

Conditions
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Generalized Anxiety Disorder, Chest Pain, Panic

Intervention / Treatment
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* Behavioral: Primary care follow-up
* Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance
* Behavioral: Therapist-Administered Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult emergency department (ED) patients (≥18yoa) presenting to the ED Within 1 week of ED presentation if discharged at time of screening. Chief complaint of chest pain or similar chief complaint leading to a standard of care diagnostic protocol to rule out possible acute coronary syndrome. HEART Score of 0-3 indicating Major Adverse Cardiac Events (MACE) risk equivalent to ≤2% Functionally low risk status - (moderate HEART score of 4-6) plus diagnostic protocol evaluation with at least two serial normal troponins spaced at least six hours apart with or without cardiovascular stress testing in the observation unit. Moderate to severe anxiety as defined by a GAD-7 score ≥ 8 or a PHQ panic screener score ≥ 2 Expected to be discharged from the ED or only undergo observation <24 hours. Exclusion Criteria: > 1 week from ED discharge Traumatic reason for chest pain Those admitted to the hospital (inpatient status) as part of their ED presentation (those placed in the observation unit for planned observation less than <24 hours are eligible) Active psychosis or behavioral issues requiring psychiatric monitoring or consultation of psychiatry for psychosis, schizophrenia, or suicidal ideation Hemodynamic instability as assessed by the treating provider Issues likely to affect follow up, including prisoners and homelessness Inability to understand and speak English to participate in telehealth therapy sessions and peer support.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary care follow-up<br>Enhanced primary care coordination | Behavioral: Primary care follow-up<br>* Those randomized to primary care and enhanced primary care coordination will receive the minimal intensity treatment that includes: (1) assistance in identifying a primary care provider for participants who do not have one, (2) sharing results of diagnostic testing (including anxiety screening) with the primary care provider (results sent via EMR note, mailed letter, or delivered by participant at appointment); and (3) an educational brochure on anxiety and treatment.<br>|
| Active Comparator: Online Cognitive Behavioral Therapy<br>Online Self-Administered Anxiety Management Program plus Peer Support Guidance | Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance<br>* Individuals randomized to the online Cognitive Behavioral Therapy (CBT) + peer support guidance arm will receive access to six online, evidence-based CBT modules in the This Way Up Generalized Anxiety Course to be completed weekly or bi-monthly. Individuals who screen positive on the PHQ panic measure will complete 2 additional panic-specific homework assignments applying exposure therapy to panic (in addition to Generalized Anxiety Disorder) experiences aligned with content from the This Way Up Panic Course.<br>|
| Active Comparator: Therapist-Administered Cognitive Behavioral Therapy<br>Telehealth 8 one-hour sessions over the course of 8 to 10 weeks | Behavioral: Therapist-Administered Cognitive Behavioral Therapy<br>* Individuals randomized to therapist-led CBT via telehealth will receive 8 one-hour sessions over the course of 8 to 10 weeks via telehealth (HIPAA compliant software such as Zoom Health or AmWell) or telephone. Therapists will be master's-degreed or eligible clinicians trained in CBT by our study psychologist. Therapists will follow a manualized protocol for delivering CBT for anxiety, specifically, with a primary focus on anxiety and worry management. Individuals who screen positive on the PHQ panic measure will have training in exposure therapy added to CBT. Although many CBT trials have a standard length of 12 sessions, brief CBT lasting 4-8 sessions is equally efficacious.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Symptoms | General Anxiety Disorder-7 scale score adjusted for baseline. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety | 3 months after enrollment | 
| Anxiety Symptoms | General Anxiety Disorder-7 scale score adjusted for baseline. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety | 6 months after enrollment | 
| Anxiety Symptoms | General Anxiety Disorder-7 scale score adjusted for baseline. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety | 9 months after enrollment | 
| Anxiety Symptoms | General Anxiety Disorder-7 scale score adjusted for baseline. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety | 12 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panic Symptoms | PHQ Panic Screener adjusted for baseline | 3 months after enrollment | 
| Panic Symptoms | PHQ Panic Screener adjusted for baseline | 6 months after enrollment | 
| Panic Symptoms | PHQ Panic Screener adjusted for baseline | 9 months after enrollment | 
| Panic Symptoms | PHQ Panic Screener adjusted for baseline | 12 months after enrollment | 
| Chest Pain | Chest pain frequency as adjusted for baseline | 3 months after enrollment | 
| Chest Pain | Chest pain frequency as adjusted for baseline | 6 months after enrollment | 
| Chest Pain | Chest pain frequency as adjusted for baseline | 9 months after enrollment | 
| Chest Pain | Chest pain frequency as adjusted for baseline | 12 months after enrollment | 
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 3 months after enrollment | 
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 6 months after enrollment | 
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 9 months after enrollment | 
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 12 months after enrollment | 
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 3 months after enrollment | 
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 6 months after enrollment | 
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 9 months after enrollment | 
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 12 months after enrollment | 
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 3 months after enrollment | 
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 6 months after enrollment | 
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 9 months after enrollment | 
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 12 months after enrollment | 
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 3 months after enrollment | 
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 6 months after enrollment | 
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 9 months after enrollment | 
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 12 months after enrollment | 
| ED Utilization | Number of return visits to ED | 12 months prior to enrollment | 
| ED Utilization | Number of return visits to ED | 3 months after enrollment | 
| ED Utilization | Number of return visits to ED | 6 months after enrollment | 
| ED Utilization | Number of return visits to ED | 9 months after enrollment | 
| ED Utilization | Number of return visits to ED | 12 months after enrollment | 
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 3 months after enrollment | 
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 6 months after enrollment | 
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 9 months after enrollment | 
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 12 months after enrollment |