Recruiting

Behavioral Exposure

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05398276

Conditions

Exercise Sensitivity

Introceptive Exposure

Anxiety

Cardiac Rehabilitation

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Behavioral Exposure For Introceptive Tolerance

Health Education Control

Study Details

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.

Conditions

Exercise Sensitivity

Introceptive Exposure

Anxiety

Cardiac Rehabilitation

Study ID

NCT05398276

Start date

May 3, 2022

Status verified date

Jun, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not 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

Study Design

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Behavioral Exposure For Introceptive Tolerance

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

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.

Primary outcome measure

  • Overall minutes of exercise [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Samantha G Farris, PhD

(845) 445-2174samantha.farris@rutgers.edu

Isabelle C Barb, BA

6095752169icb24@psych.rutgers.edu

Locations

RWJ Cardiac Rehab at East Brunswick

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Victoria Larkin, DPT

(732) 7272229Victoria.larkin@rwjbh.org

Robert Wood Johnson University Hospital Somerset Cardiac Rehabilitation Program

Recruiting

Hillsborough, New Jersey, United States, 08844

Contacts

Theresa Venditti

9086852453theresa.venditti@RWJBH.org

Rutgers Emotion, Health and Behavior Laboratory Department of Psychology

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Samantha Farris, PhD

(845) 445-2174samantha.farris@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Exercise Sensitivity
  • Introceptive Exposure
  • Kinesiophobia
  • Acceptance and Commitment Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-06-12.