CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 375 target
Drug / intervention
Primary care follow-up +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04811521
NCT04811521N/AActiveUpdate OverdueUpdated 23mo ago · Completion was 10mo ago
Enrollment Stalled

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

Indiana University·interventional·Posted Mar 23, 2021·Updated Jul 30, 2024

In Brief

A clinical study evaluating Primary care follow-up, Online Self-Administered Anxiety Management Program plus Peer Support Guidance, and 1 other intervention for Generalized Anxiety Disorder and 2 related conditions. Active but no longer recruiting, targeting 375 participants across 5 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/AActiveOverdue
20222023202420252026
First PostedMar 23, 2021
Enrollment StartApr 1, 2021
Primary CompletionAug 17, 2025
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 5.3 years ago

Interventions

Primary care follow-upbehavioral

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 Guidancebehavioral

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 Therapybehavioral

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.