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

Indiana University

Status: Active, not recruiting

Conditions: Chest Pain; Generalized Anxiety Disorder; Panic

Treatments: Behavioral: Primary care follow-up; Behavioral: Therapist-Administered Cognitive Behavioral Therapy; Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT04811521

10296 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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375 participants in 3 patient groups

Primary care follow-up

Active Comparator group

Description:

Enhanced primary care coordination

Treatment:

Behavioral: Primary care follow-up

Online Cognitive Behavioral Therapy

Active Comparator group

Description:

Online Self-Administered Anxiety Management Program plus Peer Support Guidance

Treatment:

Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance

Therapist-Administered Cognitive Behavioral Therapy

Active Comparator group

Description:

Telehealth 8 one-hour sessions over the course of 8 to 10 weeks

Treatment:

Behavioral: Therapist-Administered Cognitive Behavioral Therapy