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Behavioral Exposure for Introceptive Tolerance RCT

RECRUITINGPhase 2Sponsored by Rutgers, The State University of New Jersey
Actively Recruiting
PhasePhase 2
SponsorRutgers, The State University of New Jersey
Started2022-05-03
Est. completion2026-07-31
Eligibility
Age40 Years+
Healthy vol.Accepted
Locations2 sites

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.

Eligibility

Age: 40 Years+Healthy volunteers accepted
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

Conditions5

AnxietyCardiac RehabilitationExercise SensitivityHeart DiseaseIntroceptive Exposure

Locations2 sites

RWJ Cardiac Rehab at East Brunswick
East Brunswick, New Jersey, 08816
Victoria Larkin, DPT732-727-2229Victoria.larkin@rwjbh.org
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, New Jersey, 08901
Samantha Farris, PhD845-445-2174samantha.farris@rutgers.edu

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