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Generalized Anxiety DisorderPACERNCT04811521

Patient-centered Treatment of Anxiety After Low-Risk Chest Pain in the Emergency Room

A study testing Primary care follow-up, Online Self-Administered Anxiety Management Program plus Peer Support Guidance and Therapist-Administered Cognitive Behavioral Therapy in people with Generalized Anxiety Disorder and Chest Pain, run by Indiana University at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Generalized Anxiety Disorder, Chest Pain, Panic
What is being tested?
Primary care follow-up, Online Self-Administered Anxiety Management Program plus Peer Support Guidance and Therapist-Administered Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
5 sitesUnited States
Study dates
1 Apr 2021to 17 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • > 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Indiana University Health West Hospital

    Avon, Indiana, 46123

  • Indiana University Health North Hospital

    Carmel, Indiana, 46032

  • Indiana University Health Saxony Hospital

    Fishers, Indiana, 46037

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health Ball Memorial Hosptial

    Muncie, Indiana, 47303

Other trials in United States

About this study

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.

Read the 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.

Being tested
Primary care follow-up, Online Self-Administered Anxiety Management Program plus Peer Support Guidance, Therapist-Administered Cognitive Behavioral Therapy
Medical subject headings
Generalized Anxiety Disorder, Chest Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary care follow-upBehavioural

    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 GuidanceBehavioural

    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 TherapyBehavioural

    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.

Study groups in NCT04811521
Study groupRoleWhat they receive
Primary care follow-upActive comparatorEnhanced primary care coordination
Receives: Behavioral: Primary care follow-up
Online Cognitive Behavioral TherapyActive comparatorOnline Self-Administered Anxiety Management Program plus Peer Support Guidance
Receives: Behavioral: Online Self-Administered Anxiety Management Program plus Peer Support Guidance
Therapist-Administered Cognitive Behavioral TherapyActive comparatorTelehealth 8 one-hour sessions over the course of 8 to 10 weeks
Receives: Behavioral: Therapist-Administered Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months after enrollment

  2. 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

    Measured: 6 months after enrollment

  3. 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

    Measured: 9 months after enrollment

  4. 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

    Measured: 12 months after enrollment

Secondary outcomes (33)

  1. Panic Symptoms

    PHQ Panic Screener adjusted for baseline

    Measured: 3 months after enrollment

  2. Panic Symptoms

    PHQ Panic Screener adjusted for baseline

    Measured: 6 months after enrollment

  3. Panic Symptoms

    PHQ Panic Screener adjusted for baseline

    Measured: 9 months after enrollment

  4. Panic Symptoms

    PHQ Panic Screener adjusted for baseline

    Measured: 12 months after enrollment

  5. Chest Pain

    Chest pain frequency as adjusted for baseline

    Measured: 3 months after enrollment

  6. Chest Pain

    Chest pain frequency as adjusted for baseline

    Measured: 6 months after enrollment

  7. Chest Pain

    Chest pain frequency as adjusted for baseline

    Measured: 9 months after enrollment

  8. Chest Pain

    Chest pain frequency as adjusted for baseline

    Measured: 12 months after enrollment

  9. Physical Symptoms

    PHQ-15 total score as adjusted for baseline

    Measured: 3 months after enrollment

  10. Physical Symptoms

    PHQ-15 total score as adjusted for baseline

    Measured: 6 months after enrollment

  11. Physical Symptoms

    PHQ-15 total score as adjusted for baseline

    Measured: 9 months after enrollment

  12. Physical Symptoms

    PHQ-15 total score as adjusted for baseline

    Measured: 12 months after enrollment

  13. Depression symptoms

    PHQ-8 total score as adjusted for baseline

    Measured: 3 months after enrollment

  14. Depression symptoms

    PHQ-8 total score as adjusted for baseline

    Measured: 6 months after enrollment

  15. Depression symptoms

    PHQ-8 total score as adjusted for baseline

    Measured: 9 months after enrollment

  16. Depression symptoms

    PHQ-8 total score as adjusted for baseline

    Measured: 12 months after enrollment

  17. Work/family/social functioning

    Sheehan Disability scale as adjusted for baseline

    Measured: 3 months after enrollment

  18. Work/family/social functioning

    Sheehan Disability scale as adjusted for baseline

    Measured: 6 months after enrollment

  19. Work/family/social functioning

    Sheehan Disability scale as adjusted for baseline

    Measured: 9 months after enrollment

  20. Work/family/social functioning

    Sheehan Disability scale as adjusted for baseline

    Measured: 12 months after enrollment

  21. Global Anxiety Change

    Patient-rated global anxiety change since enrollment

    Measured: 3 months after enrollment

  22. Global Anxiety Change

    Patient-rated global anxiety change since enrollment

    Measured: 6 months after enrollment

  23. Global Anxiety Change

    Patient-rated global anxiety change since enrollment

    Measured: 9 months after enrollment

  24. Global Anxiety Change

    Patient-rated global anxiety change since enrollment

    Measured: 12 months after enrollment

  25. ED Utilization

    Number of return visits to ED

    Measured: 12 months prior to enrollment

  26. ED Utilization

    Number of return visits to ED

    Measured: 3 months after enrollment

  27. ED Utilization

    Number of return visits to ED

    Measured: 6 months after enrollment

  28. ED Utilization

    Number of return visits to ED

    Measured: 9 months after enrollment

  29. ED Utilization

    Number of return visits to ED

    Measured: 12 months after enrollment

  30. Adverse Cardiac Events

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

    Measured: 3 months after enrollment

  31. Adverse Cardiac Events

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

    Measured: 6 months after enrollment

  32. Adverse Cardiac Events

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

    Measured: 9 months after enrollment

  33. Adverse Cardiac Events

    Number of major adverse cardiac events (death, myocardial infarction, revascularization)

    Measured: 12 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start1 Apr 2021
  3. Primary completion17 Aug 2025 (estimated)
  4. Study completion17 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811521
Sponsor's protocol ID
10296
Acronym
PACER
Status last verified
Jul 2024
First submitted
19 Mar 2021
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 24120629

  • Eslick GD, Talley NJ. Natural history and predictors of outcome for non-cardiac chest pain: a prospective 4-year cohort study. Neurogastroenterol Motil. 2008 Sep;20(9):989-97. doi: 10.1111/j.1365-2982.2008.01133.x. Epub 2008 May 6.

    PubMed 18466221

  • Musey PI Jr, Patel R, Fry C, Jimenez G, Koene R, Kline JA. Anxiety Associated With Increased Risk for Emergency Department Recidivism in Patients With Low-Risk Chest Pain. Am J Cardiol. 2018 Oct 1;122(7):1133-1141. doi: 10.1016/j.amjcard.2018.06.044. Epub 2018 Jul 5.

    PubMed 30086878

  • Webster R, Norman P, Goodacre S, Thompson AR, McEachan RR. Illness representations, psychological distress and non-cardiac chest pain in patients attending an emergency department. Psychol Health. 2014;29(11):1265-82. doi: 10.1080/08870446.2014.923885. Epub 2014 Jun 18.

    PubMed 24831735

  • Foldes-Busque G, Marchand A, Chauny JM, Poitras J, Diodati J, Denis I, Lessard MJ, Pelland ME, Fleet R. Unexplained chest pain in the ED: could it be panic? Am J Emerg Med. 2011 Sep;29(7):743-51. doi: 10.1016/j.ajem.2010.02.021. Epub 2010 May 1.

    PubMed 20825891

  • Demiryoguran NS, Karcioglu O, Topacoglu H, Kiyan S, Ozbay D, Onur E, Korkmaz T, Demir OF. Anxiety disorder in patients with non-specific chest pain in the emergency setting. Emerg Med J. 2006 Feb;23(2):99-102. doi: 10.1136/emj.2005.025163.

    PubMed 16439735

  • Eken C, Oktay C, Bacanli A, Gulen B, Koparan C, Ugras SS, Cete Y. Anxiety and depressive disorders in patients presenting with chest pain to the emergency department: a comparison between cardiac and non-cardiac origin. J Emerg Med. 2010 Aug;39(2):144-50. doi: 10.1016/j.jemermed.2007.11.087. Epub 2008 Aug 23.

    PubMed 18722737

  • Aikens JE, Michael E, Levin T, Myers TC, Lowry E, McCracken LM. Cardiac exposure history as a determinant of symptoms and emergency department utilization in noncardiac chest pain patients. J Behav Med. 1999 Dec;22(6):605-17. doi: 10.1023/a:1018745813664.

    PubMed 10650539

  • Hunot V, Churchill R, Silva de Lima M, Teixeira V. Psychological therapies for generalised anxiety disorder. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD001848. doi: 10.1002/14651858.CD001848.pub4.

    PubMed 17253466

  • Kisely SR, Campbell LA, Yelland MJ, Paydar A. Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD004101. doi: 10.1002/14651858.CD004101.pub4.

    PubMed 22696339

  • Nault Connors JD, Prittie A, Musey PI. Why an Algorithmic "Rule-Out MI" Order Set Is Necessary But Not Sufficient Care for Chest Pain in the Emergency Department Setting. J Patient Exp. 2020 Oct;7(5):685-687. doi: 10.1177/2374373519881279. Epub 2019 Oct 15. No abstract available.

    PubMed 33294601

  • Napoli AM, Baird J, Tran S, Wang J. Low Adverse Event Rates But High Emergency Department Utilization in Chest Pain Patients Treated in an Emergency Department Observation Unit. Crit Pathw Cardiol. 2017 Mar;16(1):15-21. doi: 10.1097/HPC.0000000000000099.

    PubMed 28195938

  • Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.

    PubMed 23465250

  • Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.

    PubMed 17339617

Questions about this trial

What is this clinical trial studying?

A study testing Primary care follow-up, Online Self-Administered Anxiety Management Program plus Peer Support Guidance and Therapist-Administered Cognitive Behavioral Therapy in people with Generalized Anxiety Disorder and Chest Pain, run by Indiana University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety Symptoms (time frame: 3 months after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04811521, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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