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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary care follow-up | Active Comparator | Enhanced primary care coordination |
|
| Online Cognitive Behavioral Therapy | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Panic Symptoms | PHQ Panic Screener adjusted for baseline | 3 months after enrollment |
| Panic Symptoms | PHQ Panic Screener adjusted for baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Musey, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health West Hospital | Avon | Indiana | 46123 | United States | ||
| Indiana University Health North Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Rui P, Kang K. National Hospital Ambulatory Medical Care Survey: 2015 Emergency Department Summary Tables. CDC, US Centers for Disease Control and Prevention; 2015:34. | ||
| 24120629 | Background | Kline JA, Shapiro NI, Jones AE, Hernandez J, Hogg MM, Troyer J, Nelson RD. Outcomes and radiation exposure of emergency department patients with chest pain and shortness of breath and ultralow pretest probability: a multicenter study. Ann Emerg Med. 2014 Mar;63(3):281-8. doi: 10.1016/j.annemergmed.2013.09.009. Epub 2013 Oct 10. | |
| 18466221 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 13, 2026 | |
| Reset | May 1, 2026 | |
| Release | Jun 2, 2026 |
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|
| 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. |
|
| 6 months after enrollment |
| Panic Symptoms | PHQ Panic Screener adjusted for baseline | 9 months after enrollment |
| Panic Symptoms | PHQ Panic Screener adjusted for baseline | 12 months after enrollment |
| Chest Pain | Chest pain frequency as adjusted for baseline | 3 months after enrollment |
| Chest Pain | Chest pain frequency as adjusted for baseline | 6 months after enrollment |
| Chest Pain | Chest pain frequency as adjusted for baseline | 9 months after enrollment |
| Chest Pain | Chest pain frequency as adjusted for baseline | 12 months after enrollment |
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 3 months after enrollment |
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 6 months after enrollment |
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 9 months after enrollment |
| Physical Symptoms | PHQ-15 total score as adjusted for baseline | 12 months after enrollment |
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 3 months after enrollment |
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 6 months after enrollment |
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 9 months after enrollment |
| Depression symptoms | PHQ-8 total score as adjusted for baseline | 12 months after enrollment |
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 3 months after enrollment |
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 6 months after enrollment |
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 9 months after enrollment |
| Work/family/social functioning | Sheehan Disability scale as adjusted for baseline | 12 months after enrollment |
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 3 months after enrollment |
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 6 months after enrollment |
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 9 months after enrollment |
| Global Anxiety Change | Patient-rated global anxiety change since enrollment | 12 months after enrollment |
| ED Utilization | Number of return visits to ED | 12 months prior to enrollment |
| ED Utilization | Number of return visits to ED | 3 months after enrollment |
| ED Utilization | Number of return visits to ED | 6 months after enrollment |
| ED Utilization | Number of return visits to ED | 9 months after enrollment |
| ED Utilization | Number of return visits to ED | 12 months after enrollment |
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 3 months after enrollment |
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 6 months after enrollment |
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 9 months after enrollment |
| Adverse Cardiac Events | Number of major adverse cardiac events (death, myocardial infarction, revascularization) | 12 months after enrollment |
| Carmel |
| Indiana |
| 46032 |
| United States |
| Indiana University Health Saxony Hospital | Fishers | Indiana | 46037 | United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health Ball Memorial Hosptial | Muncie | Indiana | 47303 | United States |
| Background |
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| Reset | Jun 25, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 13, 2026 | May 1, 2026 | |||
| Jun 2, 2026 | Jun 25, 2026 |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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