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

Generalized Anxiety Disorder Clinical Trial

— PACER  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04811521
• Other study ID #: 10296
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 375
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Chest Pain
• Emergencies
• Generalized Anxiety Disorder
• Panic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Panic Symptoms	PHQ Panic Screener adjusted for baseline	3 months after enrollment
Secondary	Panic Symptoms	PHQ Panic Screener adjusted for baseline	6 months after enrollment
Secondary	Panic Symptoms	PHQ Panic Screener adjusted for baseline	9 months after enrollment
Secondary	Panic Symptoms	PHQ Panic Screener adjusted for baseline	12 months after enrollment
Secondary	Chest Pain	Chest pain frequency as adjusted for baseline	3 months after enrollment
Secondary	Chest Pain	Chest pain frequency as adjusted for baseline	6 months after enrollment
Secondary	Chest Pain	Chest pain frequency as adjusted for baseline	9 months after enrollment
Secondary	Chest Pain	Chest pain frequency as adjusted for baseline	12 months after enrollment
Secondary	Physical Symptoms	PHQ-15 total score as adjusted for baseline	3 months after enrollment
Secondary	Physical Symptoms	PHQ-15 total score as adjusted for baseline	6 months after enrollment
Secondary	Physical Symptoms	PHQ-15 total score as adjusted for baseline	9 months after enrollment
Secondary	Physical Symptoms	PHQ-15 total score as adjusted for baseline	12 months after enrollment
Secondary	Depression symptoms	PHQ-8 total score as adjusted for baseline	3 months after enrollment
Secondary	Depression symptoms	PHQ-8 total score as adjusted for baseline	6 months after enrollment
Secondary	Depression symptoms	PHQ-8 total score as adjusted for baseline	9 months after enrollment
Secondary	Depression symptoms	PHQ-8 total score as adjusted for baseline	12 months after enrollment
Secondary	Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	3 months after enrollment
Secondary	Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	6 months after enrollment
Secondary	Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	9 months after enrollment
Secondary	Work/family/social functioning	Sheehan Disability scale as adjusted for baseline	12 months after enrollment
Secondary	Global Anxiety Change	Patient-rated global anxiety change since enrollment	3 months after enrollment
Secondary	Global Anxiety Change	Patient-rated global anxiety change since enrollment	6 months after enrollment
Secondary	Global Anxiety Change	Patient-rated global anxiety change since enrollment	9 months after enrollment
Secondary	Global Anxiety Change	Patient-rated global anxiety change since enrollment	12 months after enrollment
Secondary	ED Utilization	Number of return visits to ED	12 months prior to enrollment
Secondary	ED Utilization	Number of return visits to ED	3 months after enrollment
Secondary	ED Utilization	Number of return visits to ED	6 months after enrollment
Secondary	ED Utilization	Number of return visits to ED	9 months after enrollment
Secondary	ED Utilization	Number of return visits to ED	12 months after enrollment
Secondary	Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	3 months after enrollment
Secondary	Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	6 months after enrollment
Secondary	Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	9 months after enrollment
Secondary	Adverse Cardiac Events	Number of major adverse cardiac events (death, myocardial infarction, revascularization)	12 months after enrollment