Status:
RECRUITING
Behavioral Exposure for Introceptive Tolerance RCT
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Exercise Sensitivity
Introceptive Exposure
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 fea...
Detailed Description
This study is a Stage II randomized-controlled trial of a novel behavioral intervention, titled Behavioral Exposure for Interoceptive Tolerance (BE-FIT), to evaluate (1) its efficacy in improving exer...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT05398276
Start Date
May 3 2022
End Date
July 31 2026
Last Update
March 27 2024
Active Locations (2)
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1
RWJ Cardiac Rehab at East Brunswick
East Brunswick, New Jersey, United States, 08816
2
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, New Jersey, United States, 08901