Actively Recruiting
Behavioral Exposure for Introceptive Tolerance RCT
Led by Rutgers, The State University of New Jersey · Updated on 2024-03-27
146
Participants Needed
2
Research Sites
221 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Behavioral Exposure for Introceptive Tolerance RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years of age or older
- Elevated exercise anxiety with a score of 30 or higher on the Exercise Sensitivity Questionnaire (ESQ-18)
- Low physical activity, defined as less than 90 minutes of moderate-to-vigorous intensity exercise per day in the past three months
- Medically approved to participate in cardiac rehabilitation
- Proficient in English
You will not qualify if you...
- Evidence of cognitive impairment, defined as a score of 23 or lower on the Montreal Cognitive Assessment (MoCA)
- Severe disabling chronic medical or psychiatric conditions preventing safe or adequate participation
- Expected inability to survive through the study period
AI-Screening
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Trial Site Locations
Total: 2 locations
1
RWJ Cardiac Rehab at East Brunswick
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
2
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
S
Samantha G Farris, PhD
CONTACT
M
Mindy Kibbey, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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