Behavioral Exposure for Introceptive Tolerance RCT

RECRUITING

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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.

Conditions:

Exercise Sensitivity Introceptive Exposure Anxiety Cardiac Rehabilitation

Study Start (Actual) 2022-05-03

Primary Completion (Estimated) 2026-07-31

Study Completion (Estimated) 2026-07-31

Enrollment (Estimated) 146

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 East Brunswick, New Jersey, United States

📍 New Brunswick, New Jersey, United States

Eligibility Criteria

Description

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

Ages Eligible for Study: 40 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-05-26
First Submitted that Met QC Criteria2022-05-26
First Posted2022-05-31

Study Record Updates

Last Update Submitted that Met QC Criteria2024-03-25
Last Update Posted2024-03-27
Last Verified2024-03