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

NCT04811521 | Active Not Recruiting DMC

• 1 other identifier: 10296
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 5

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.

Conditions

Generalized Anxiety Disorder; Chest Pain; Panic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (33)

• Panic Symptoms

  3 months after enrollment

• Panic Symptoms

  6 months after enrollment

• Panic Symptoms

  9 months after enrollment

• Panic Symptoms

  12 months after enrollment

• Chest Pain

  3 months after enrollment

Study Arms (3)

Primary care follow-up

ACTIVE COMPARATOR

Enhanced primary care coordination

Behavioral: Primary care follow-up

Online Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Online Self-Administered Anxiety Management Program plus Peer Support Guidance

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

Therapist-Administered Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Behavioral: Therapist-Administered Cognitive Behavioral Therapy

Interventions

Primary care follow-up BEHAVIORAL

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.

Primary care follow-up

Online Self-Administered Anxiety Management Program plus Peer Support Guidance BEHAVIORAL

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.

Online Cognitive Behavioral Therapy

Therapist-Administered Cognitive Behavioral Therapy BEHAVIORAL

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.

Therapist-Administered Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Indiana University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Indiana University Health West Hospital

Avon, Indiana, 46123, United States

Location

Indiana University Health North Hospital

Carmel, Indiana, 46032, United States

Location

Indiana University Health Saxony Hospital

Fishers, Indiana, 46037, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Ball Memorial Hosptial

Muncie, Indiana, 47303, United States

Location

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  PMID: 41436014 DERIVED

• Dang L, Kroenke K, Connors J, Stump TE, Monahan PO, Chernyak Y, Holmes E, Hoffman C, Prather K, Musey PI. Psychological Comorbidity in Patients Presenting to the Emergency Department With Low-Risk Chest Pain and Anxiety. Acad Emerg Med. 2025 Aug 8. doi: 10.1111/acem.70113. Online ahead of print.

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• Connors JN, Kroenke K, Monahan P, Chernyak Y, Pettit K, Hayden J, Montgomery C, Brenner G, Millard M, Holmes E, Musey P. Comparing the effectiveness of existing anxiety treatment options among patients evaluated for chest pain and anxiety in the emergency department setting: Study protocol for the PACER pragmatic randomized comparative effectiveness trial. Contemp Clin Trials. 2023 Jan;124:107020. doi: 10.1016/j.cct.2022.107020. Epub 2022 Nov 21.

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MeSH Terms

Conditions

Generalized Anxiety Disorder; Chest Pain

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Musey, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: April 1, 2021
• Primary Completion: August 17, 2025
• Study Completion: August 17, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)