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Active, Not Recruiting

NCT Number: NCT04811521

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Chest Pain Mental Disorders Neurologic Manifestations Pain Panic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health West Hospital, Avon, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Anxiety Symptoms

    Time frame: 3 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

  2. Anxiety Symptoms

    Time frame: 6 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

  3. Anxiety Symptoms

    Time frame: 9 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

  4. Anxiety Symptoms

    Time frame: 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 outcomes

  1. Panic Symptoms

    Time frame: 3 months after enrollment

    PHQ Panic Screener adjusted for baseline

  2. Panic Symptoms

    Time frame: 6 months after enrollment

    PHQ Panic Screener adjusted for baseline

  3. Panic Symptoms

    Time frame: 9 months after enrollment

    PHQ Panic Screener adjusted for baseline

  4. Panic Symptoms

    Time frame: 12 months after enrollment

    PHQ Panic Screener adjusted for baseline

  5. Chest Pain

    Time frame: 3 months after enrollment

    Chest pain frequency as adjusted for baseline

  6. Chest Pain

    Time frame: 6 months after enrollment

    Chest pain frequency as adjusted for baseline

  7. Chest Pain

    Time frame: 9 months after enrollment

    Chest pain frequency as adjusted for baseline

  8. Chest Pain

    Time frame: 12 months after enrollment

    Chest pain frequency as adjusted for baseline

  9. Physical Symptoms

    Time frame: 3 months after enrollment

    PHQ-15 total score as adjusted for baseline

  10. Physical Symptoms

    Time frame: 6 months after enrollment

    PHQ-15 total score as adjusted for baseline

  11. Physical Symptoms

    Time frame: 9 months after enrollment

    PHQ-15 total score as adjusted for baseline

  12. Physical Symptoms

    Time frame: 12 months after enrollment

    PHQ-15 total score as adjusted for baseline

  13. Depression symptoms

    Time frame: 3 months after enrollment

    PHQ-8 total score as adjusted for baseline

  14. Depression symptoms

    Time frame: 6 months after enrollment

    PHQ-8 total score as adjusted for baseline

  15. Depression symptoms

    Time frame: 9 months after enrollment

    PHQ-8 total score as adjusted for baseline

  16. Depression symptoms

    Time frame: 12 months after enrollment

    PHQ-8 total score as adjusted for baseline

  17. Work/family/social functioning

    Time frame: 3 months after enrollment

    Sheehan Disability scale as adjusted for baseline

  18. Work/family/social functioning

    Time frame: 6 months after enrollment

    Sheehan Disability scale as adjusted for baseline

  19. Work/family/social functioning

    Time frame: 9 months after enrollment

    Sheehan Disability scale as adjusted for baseline

  20. Work/family/social functioning

    Time frame: 12 months after enrollment

    Sheehan Disability scale as adjusted for baseline

  21. Global Anxiety Change

    Time frame: 3 months after enrollment

    Patient-rated global anxiety change since enrollment

  22. Global Anxiety Change

    Time frame: 6 months after enrollment

    Patient-rated global anxiety change since enrollment

  23. Global Anxiety Change

    Time frame: 9 months after enrollment

    Patient-rated global anxiety change since enrollment

  24. Global Anxiety Change

    Time frame: 12 months after enrollment

    Patient-rated global anxiety change since enrollment

  25. ED Utilization

    Time frame: 12 months prior to enrollment

    Number of return visits to ED

  26. ED Utilization

    Time frame: 3 months after enrollment

    Number of return visits to ED

  27. ED Utilization

    Time frame: 6 months after enrollment

    Number of return visits to ED

  28. ED Utilization

    Time frame: 9 months after enrollment

    Number of return visits to ED

  29. ED Utilization

    Time frame: 12 months after enrollment

    Number of return visits to ED

  30. Adverse Cardiac Events

    Time frame: 3 months after enrollment

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

  31. Adverse Cardiac Events

    Time frame: 6 months after enrollment

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

  32. Adverse Cardiac Events

    Time frame: 9 months after enrollment

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

  33. Adverse Cardiac Events

    Time frame: 12 months after enrollment

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: PACER

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2021
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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