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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after enrollment
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 moreAwards & 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
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,683 Total Patients Enrolled
2 Trials studying Chest Pain
926 Patients Enrolled for Chest Pain
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,684 Total Patients Enrolled
1 Trials studying Chest Pain
898 Patients Enrolled for Chest Pain
Paul Musey, MDPrincipal InvestigatorIndiana University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your HEART score is between 0 and 3, which means your risk of heart problems is low.I was discharged from the emergency department more than a week ago.I am an adult who went to the emergency department within the last week.Your blood pressure and heart rate are not stable, according to your doctor.I went to the doctor because of chest pain to check for heart problems.My heart risk score is moderate, and tests show my heart is functioning well.You have ongoing serious mental health issues that need regular monitoring or consultation with a psychiatrist.I have moderate to severe anxiety.My chest pain is due to an injury.
Research Study Groups:
This trial has the following groups:- Group 1: Primary care follow-up
- Group 2: Online Cognitive Behavioral Therapy
- Group 3: Therapist-Administered Cognitive Behavioral Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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