Chest Pain, Generalized Anxiety Disorder, Panic
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORALPrimary 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.
BEHAVIORALOnline 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.
BEHAVIORALTherapist-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.
Sponsors
Patient-Centered Outcomes Research Institute
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest Pain | 3 months after enrollment | Chest pain frequency as adjusted for baseline |
| Physical Symptoms | 3 months after enrollment | PHQ-15 total score as adjusted for baseline |
| Depression symptoms | 3 months after enrollment | PHQ-8 total score as adjusted for baseline |
| Panic Symptoms | 3 months after enrollment | PHQ Panic Screener adjusted for baseline |
| Global Anxiety Change | 3 months after enrollment | Patient-rated global anxiety change since enrollment |
| ED Utilization | 12 months prior to enrollment | Number of return visits to ED |
| Adverse Cardiac Events | 3 months after enrollment | Number of major adverse cardiac events (death, myocardial infarction, revascularization) |
| Work/family/social functioning | 3 months after enrollment | Sheehan Disability scale as adjusted for baseline |
Countries
United States
Outcome results
None listed