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Behavioral Exposure for Introceptive Tolerance RCT

RecruitingNAAges 40 Years - anyAllRutgers, The State University of New Jersey
NCT05398276 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 thi

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📋 Eligibility rules (as published)
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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What it tests

  • Behavioral Exposure For Introceptive Tolerance
  • Health Education Control
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Where

3 sites
RWJ Cardiac Rehab at East Brunswick
East Brunswick, United States
Robert Wood Johnson University Hospital Somerset Cardiac Rehabilitation Program
Hillsborough, United States
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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