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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04811521
Other study ID # 10296
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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 allClick 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
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