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

Not Applicable

Active, not recruiting

• Conditions: Panic; Chest Pain; Generalized Anxiety Disorder
• Interventions: Behavioral: Therapist-Administered Cognitive Behavioral Therapy; Behavioral: Primary care follow-up; Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance

• Registration Number: NCT04811521
• Lead Sponsor: Indiana University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-08-17
• Study Completion: 2025-08-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapist-Administered Cognitive Behavioral Therapy	Therapist-Administered Cognitive Behavioral Therapy	Telehealth 8 one-hour sessions over the course of 8 to 10 weeks
Primary care follow-up	Primary care follow-up	Enhanced primary care coordination
Online Cognitive Behavioral Therapy	Online Self-Administered Anxiety Management Program plus Peer Support Guidance	Online Self-Administered Anxiety Management Program plus Peer Support Guidance

Primary Outcome Measures

Name	Time	Method
Anxiety Symptoms	12 months after enrollment	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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Indiana University Health North Hospital; 🇺🇸 Carmel, Indiana, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Health West Hospital; 🇺🇸 Avon, Indiana, United States

Indiana University Health Saxony Hospital; 🇺🇸 Fishers, Indiana, United States

Indiana University Health Ball Memorial Hosptial; 🇺🇸 Muncie, Indiana, United States