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Recruiting Phase 2 NCT05398276

Behavioral Exposure for Introceptive Tolerance RCT

◆ AI Clinical Summary

This study tests a new treatment called BE-FIT that helps people overcome anxiety related to exercise and uncomfortable body sensations during physical activity. The treatment uses gradual exposure to feared sensations and exercise while teaching you to avoid safety behaviors that might reinforce anxiety.

Key Objective: The trial is testing whether learning to tolerate bodily sensations through guided exercise exposure can reduce exercise anxiety and improve physical activity participation.

Who to Consider: People who experience significant anxiety during or in anticipation of exercise, or who have concerns about physical sensations like rapid heartbeat or shortness of breath during activity, should consider enrolling.

Trial Parameters

Condition Exercise Sensitivity
Sponsor Rutgers, The State University of New Jersey
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 146
Sex ALL
Min Age 40 Years
Max Age N/A
Start Date 2022-05-03
Completion 2026-07-31
Interventions
Behavioral Exposure For Introceptive ToleranceHealth Education Control

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. ≥ 40 years of age 2. Elevated exercise anxiety (score of ≥ 30 on ESQ-18) 3. Low active (\< 90 min self-reported moderate-to-vigorous intensity physical activity/day in past three months) 4. Medically approved cardiac rehabilitation 5. English proficiency Exclusion Criteria: 1. Evidence of cognitive impairment (≤ 23 on Montreal Cognitive Assessment; MoCA) 2. Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation 3. Expectation that patient will not live through study periods

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