Behavioral Exposure for Introceptive Tolerance RCT

Part of paid clinical trials in East Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05398276
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anxiety
  • Cardiac Rehabilitation
  • Exercise Sensitivity
  • Introceptive Exposure

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Exposure For Introceptive Tolerance — BEHAVIORAL
    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.
  • Health Education Control — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 3, 2022
Status verified
Mar 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Behavioral Exposure For Introceptive Tolerance
    The 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.
  • Active Comparator: Health Education Control
    HEC 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.

Primary Outcome Measure

Overall minutes of exercise [ Time Frame: 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
RWJ Cardiac Rehab at East BrunswickEast BrunswickNew Jersey08816
Victoria Larkin, DPT
[email protected]
732-727-2229
Rutgers Emotion, Health and Behavior Laboratory Department of PsychologyNew BrunswickNew Jersey08901
Samantha Farris, PhD
[email protected]
845-445-2174

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By research site
RWJ Cardiac Rehab at East Brunswick· East Brunswick, NJRutgers Emotion, Health and Behavior Laboratory Department of Psychology· New Brunswick, NJ

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