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NCT05398276 · ClinicalTrials.gov registry record · Phase 2
Behavioral Exposure for Introceptive Tolerance RCT
A Phase 2 study of Anxiety and Cardiac Rehabilitation, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
- 2
- Study locations
NCT05398276: Recruiting Phase 2 study of Anxiety and Cardiac Rehabilitation, sponsored by Rutgers, The State University of New Jersey.
NCT05398276 is a Phase 2 study of Anxiety and Cardiac Rehabilitation that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 146 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05398276, a Phase 2 study of Anxiety and Cardiac Rehabilitation, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
- 2
- Study locations
Study Summary
Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is a mechanism-informed behavioral intervention to target exercise anxiety. The three primary components of BE-FIT include: (1) exposure to feared bodily sensations and exercise; (2) prevention of safety behavior use before/during/after exercise, and (3) use of a wrist-worn activity monitor for physical activity (PA) feedback and activity goal setting. Evidence from the investigators' Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and produced reductions in exercise anxiety and increased exercise outcomes (short-term moderate-to-vigorous intensity physical activity and steps/day). The investigators' present aim is to conduct a Stage II randomized-controlled trial to further evaluate the efficacy of BE-FIT in decreasing exercise anxiety in cardiac rehabilitation (CR) patients and examine whether changes in this target yield successive changes in exercise adherence outcomes.
Primary Outcome
Objectively measured exercise (moderate-to-vigorous intensity physical activity mins/day) on both CR and non-CR days.
Conditions Studied
Interventions
- BEHAVIORAL Health Education Control
- BEHAVIORAL Behavioral Exposure For Introceptive Tolerance
Study Locations (2)
New Jersey
- RWJ Cardiac Rehab at East Brunswick - East Brunswick
- Rutgers Emotion, Health and Behavior Laboratory Department of Psychology - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What NCT05398276 shows while recruiting
NCT05398276 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (67% lower).
The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Health Education Control is the first listed.
NCT05398276 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05398276 about?
NCT05398276 is a clinical study titled "Behavioral Exposure for Introceptive Tolerance RCT". Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is a mechanism-informed behavioral intervention to target exercise anxiety. The three primary components of BE-FIT include: (1) exposure to feared bodily sensations and exercise; (2) prevention of safety behavior use before/during/after exerci...
What is the current status of trial NCT05398276?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2022-05-03. Estimated completion is 2026-07-31.
What conditions does trial NCT05398276 study?
This clinical trial studies the following conditions: Anxiety, Cardiac Rehabilitation, Exercise Sensitivity, Introceptive Exposure.
What interventions are being tested in trial NCT05398276?
The interventions under investigation include: Health Education Control (BEHAVIORAL), Behavioral Exposure For Introceptive Tolerance (BEHAVIORAL).
Who is sponsoring clinical trial NCT05398276?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05398276 being conducted?
This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05398276's enrollment target sits among peer trials
146 124th of 364 higher than 240 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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