Generalized Anxiety Disorder Clinical Trial
— PACEROfficial title:
Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room
Verified date | June 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Patient-Centered Outcomes Research Institute |
United States,
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* Note: There are 49 references in all — Click here to view all references
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 |
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