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

N/AActive Not RecruitingNCT04811521

Indiana University375 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

375

Conditions

Generalized Anxiety Disorder Chest Pain Panic

Interventions

Primary care follow-upBEHAVIORAL

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.

Online Self-Administered Anxiety Management Program plus Peer Support GuidanceBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Indiana University Health West Hospital

Avon, Indiana, United States

Indiana University Health North Hospital

Carmel, Indiana, United States

Indiana University Health Saxony Hospital

Fishers, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months after enrollment

Secondary Outcomes

Panic Symptoms

PHQ Panic Screener adjusted for baseline

Time frame: 3 months after enrollment

Panic Symptoms

PHQ Panic Screener adjusted for baseline

Time frame: 6 months after enrollment

Panic Symptoms

PHQ Panic Screener adjusted for baseline

Time frame: 9 months after enrollment

Panic Symptoms

PHQ Panic Screener adjusted for baseline

Data from ClinicalTrials.gov

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