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Behavioral Intervention

Anxiety Management for Anxiety Disorders (PACER Trial)

N/A
Waitlist Available
Led By Paul Musey, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate to severe anxiety as defined by a GAD-7 score ≥ 8 or a PHQ panic screener score ≥ 2.
Be older than 18 years old
Must not have
Traumatic reason for chest pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the benefits and risks of three different anxiety treatments to see which is most effective.

Who is the study for?
This trial is for adults who visited the ER with low-risk chest pain and have moderate to severe anxiety. They must have a certain score on heart risk and anxiety assessments, be expected to leave the ER within 24 hours, and speak English. People admitted as inpatients or with active psychosis, traumatic chest pain, unstable vital signs, homelessness, or inability to follow up are excluded.
What is being tested?
The study compares three treatments for anxiety after experiencing chest pain: therapist-led cognitive behavioral therapy (CBT), standard primary care follow-up, and an online self-help program with peer support. The aim is to see which method works best for reducing anxiety in this setting.
What are the potential side effects?
While not explicitly listed here, common side effects of CBT may include temporary increases in distress due to confronting fears or anxieties. Online programs might lead to feelings of isolation without proper guidance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate to severe anxiety.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My chest pain is due to an injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety
Secondary study objectives
Adverse Cardiac Events
Chest Pain
Depression symptoms
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Primary care follow-upActive Control1 Intervention
Enhanced primary care coordination
Group II: Online Cognitive Behavioral TherapyActive Control1 Intervention
Online Self-Administered Anxiety Management Program plus Peer Support Guidance
Group III: Therapist-Administered Cognitive Behavioral TherapyActive Control1 Intervention
Telehealth 8 one-hour sessions over the course of 8 to 10 weeks

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,035 Previous Clinical Trials
1,218,604 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
573 Previous Clinical Trials
27,077,857 Total Patients Enrolled
Paul Musey, MDPrincipal InvestigatorIndiana University

Media Library

Online Self-Administered Anxiety Management Program plus Peer Support Guidance (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04811521 — N/A
Spinal Cord Injury Research Study Groups: Primary care follow-up, Online Cognitive Behavioral Therapy, Therapist-Administered Cognitive Behavioral Therapy
Spinal Cord Injury Clinical Trial 2023: Online Self-Administered Anxiety Management Program plus Peer Support Guidance Highlights & Side Effects. Trial Name: NCT04811521 — N/A
Online Self-Administered Anxiety Management Program plus Peer Support Guidance (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04811521 — N/A
~65 spots leftby Aug 2025