Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
NCT ID: NCT04811521
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
375 participants
INTERVENTIONAL
2021-04-01
2025-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Primary care follow-up
Enhanced primary care coordination
Primary care follow-up
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 Cognitive Behavioral Therapy
Online Self-Administered Anxiety Management Program plus Peer Support Guidance
Online Self-Administered Anxiety Management Program plus Peer Support Guidance
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.
Therapist-Administered Cognitive Behavioral Therapy
Telehealth 8 one-hour sessions over the course of 8 to 10 weeks
Therapist-Administered Cognitive Behavioral Therapy
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.
Interventions
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Primary care follow-up
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 Guidance
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.
Therapist-Administered Cognitive Behavioral Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Indiana University
OTHER
Responsible Party
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Paul Musey
Director of Research
Principal Investigators
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Paul Musey, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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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
Indiana University Health Ball Memorial Hosptial
Muncie, Indiana, United States
Countries
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References
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Other Identifiers
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10296
Identifier Type: -
Identifier Source: org_study_id
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