Behavioral Exposure for Introceptive Tolerance RCT

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorRutgers, The State University of New Jersey

About this trial

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

Qualifiers

≥ 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Behavioral Exposure For Introceptive Tolerance
  • Health Education Control

Treatment groups

146 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rutgers, The State University of New Jersey

Lead sponsor

National Institute on Aging (NIA)

Collaborator