Behavioral Exposure for Introceptive Tolerance RCT
United States146 participantsStarted 2022-05-03
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 40 years of age
. Elevated exercise anxiety (score of ≥ 30 on ESQ-18)
. Low active (\< 90 min self-reported moderate-to-vigorous intensity physical activity/day in past three months)
. Medically approved cardiac rehabilitation
. English proficiency
Exclusion criteria
. Evidence of cognitive impairment (≤ 23 on Montreal Cognitive Assessment; MoCA)
. Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to focus on helping people with anxiety about physical sensations tolerate exercise better — could this kind of behavioral exposure approach actually help me increase my exercise time, and is that something worth discussing given my specific situation in cardiac rehab?
2Since this trial is listed as 'Phase NA,' it sounds like it's more of a behavioral or psychological intervention rather than a drug study — can you help me understand what that means for what's already known about its safety and whether it's been tested enough for someone in my condition?
3The trial is measuring overall minutes of exercise as its main outcome — does that align with what my care team is actually trying to improve for me, or would standard cardiac rehabilitation already address that goal in a more established way?
4I've read that this study involves something called interoceptive exposure, which means intentionally triggering physical sensations like a faster heartbeat — given my heart condition, is it safe for me to participate in exercises designed to provoke those kinds of sensations?
5Since the trial is currently recruiting, what would participating actually look like week to week, and would the time and visits required fit realistically into my current treatment schedule?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall minutes of exercise
Timeframe: 24 weeks
Trial details
NCT IDNCT05398276
SponsorRutgers, The State University of New Jersey