Behavioral Exposure for Introceptive Tolerance RCT
BE-FIT
A Tailored Exposure Intervention for Exercise Anxiety and Avoidance in Cardiac Rehabilitation
2 other identifiers
interventional
146
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2022
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2022
CompletedFirst Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
March 27, 2024
March 1, 2024
4.2 years
May 26, 2022
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall minutes of exercise
Objectively measured exercise (moderate-to-vigorous intensity physical activity mins/day) on both CR and non-CR days.
24 weeks
Secondary Outcomes (2)
Percent of prescribed cardiac rehabilitation attended.
24 weeks
Objectively measured Lifestyle PA (steps/day).
24 weeks
Study Arms (2)
Behavioral Exposure For Introceptive Tolerance
EXPERIMENTALThe BE-FIT intervention is a cognitive-behavioral intervention and is designed to target exercise anxiety. The three main 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 (Fitbit) for PA feedback and activity goal setting.
Health Education Control
ACTIVE COMPARATORHEC is a time-matched control intervention that will be delivered on the same delivery schedule as BE-FIT. In this arm, participants will be provided educational information about health topics relevant to healthy aging delivered through PowerPoint lectures and handouts and use a Fitbit for PA monitoring.
Interventions
BE-FIT will consist of a 6-session one-on one program with a clinician that are approximately 45 minutes delivered, over the course of 3 weeks (twice/week). Sessions will coincide with scheduled cardiac rehabilitation sessions at RWJ Cardiac Rehabilitation Program. The elements of BE-FIT are (1) psychoeducation about avoidance/anxiety and values clarification and committed action for exercise and lifestyle PA; (2) graded, repeated exposure to bodily sensations and exercise to build tolerance of discomfort; (3) fading safety behaviors and elimination of exercise avoidance behaviors to promote tolerance of uncertainty and reduce catastrophizing; and (4) use of Fitbit activity tracker to facilitate physical activity monitoring and provide physical activity feedback and goal-setting.
HEC is a time-matched control intervention that will be administered on the same delivery schedule as BE-FIT. The intervention content includes: (1) educational information about health topics relevant to healthy aging, and (2) Use of the Fitbit activity watch for PA monitoring. The 6 topics introduced in the HEC include: nutrition, sleep, brain health, emotional health, living with chronic conditions, how to be a smart patient. The health information will be conveyed through lectures and handouts. The goal of sessions will be to provide education, particularly as it relates to healthy aging. Patients will be given the same Fitbit as in the BE-FIT but will not be given PA goals.
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
RWJ Cardiac Rehab at East Brunswick
East Brunswick, New Jersey, 08816, United States
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, New Jersey, 08901, United States
Related Publications (1)
Farris SG, Kibbey MM, Derby L, Keller B, Leyro TM, Alderman BL, Steinberg MB, Abrantes AM, DiBello AM. A Confirmatory Factory Analysis of the Exercise Sensitivity Questionnaire (ESQ). J Cardiopulm Rehabil Prev. 2025 May 1;45(3):207-214. doi: 10.1097/HCR.0000000000000933. Epub 2025 Feb 28.
PMID: 40014001DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 26, 2022
First Posted
May 31, 2022
Study Start
May 3, 2022
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
March 27, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share