Behavioral Exposure for Introceptive Tolerance RCT
Recruiting · NCT05398276 · Interventional (participants receive a specific treatment) · Lead sponsor: Rutgers, The State University of New Jersey
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
- Expectation that patient will not live through study periods
Where it is running
3 locations listed across 1 US state.
- RWJ Cardiac Rehab at East Brunswick - East Brunswick, New Jersey, United States
- Robert Wood Johnson University Hospital Somerset Cardiac Rehabilitation Program - Hillsborough, New Jersey, United States
- Rutgers Emotion, Health and Behavior Laboratory Department of Psychology - New Brunswick, New Jersey, United States