Behavioral Exposure for Introceptive Tolerance RCT

Anxiety Clinical Trial

— BE-FIT  

Official title:

A Tailored Exposure Intervention for Exercise Anxiety and Avoidance in Cardiac Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398276
• Other study ID #: 2021000886
• Secondary ID: R01AG070136
• Status: Recruiting
• Phase: Phase 2
• Start date: May 3, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Samantha G Farris, PhD
• Phone: (845) 445-2174
• Email: samantha.farris[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 exercise adherence in CR and (2) its mechanisms of change in individuals 40 years of age and older. One hundred and forty-six patients enrolled in Robert Wood Johnson University Hospital (RWJ) cardiac rehabilitation (CR) program who have elevated exercise anxiety, as indicated by endorsement of much to very much concern about at least 3 items on the Exercise Sensitivity Questionnaire (ESQ; Farris et al., 2020) and meet other eligibility criteria will be randomly assigned to either receive BE-FIT, a tailored intervention specifically for CR patients with high levels of exercise anxiety (n=73), or the health education condition (HEC; n=73), which are matched for contact time. Eligible participants will be stratified based on their risk profile (determined by their electronic health record), age, sex, and ESQ score. These stratification variables were selected because they are associated with anxiety and fitness levels which could impact physical activity (PA) outcomes. Both conditions will be administered by trained doctoral-level students enrolled at Rutgers University and will be supervised throughout the course of the study by Dr. Farris and other listed co-investigators.

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. The alternative type of intervention is the Health Education Control (HEC), which is a time-matched control intervention that will be delivered on the same delivery schedule as BE-FIT. The doctoral-level clinicians who will be delivering HEC will be exclusively trained in order to avoid contamination with the BE-FIT intervention. In this control 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. The HEC protocol has been used in prior studies conducted by Dr. Abrantes (co-investigator).

The overall duration of the study is 24 weeks, or approximately 6 months. Subjects will be involved in 6 individual sessions delivered twice weekly during the initial weeks of outpatient CR. Sessions occur for 45 minutes either immediately before or after regularly scheduled CR sessions. Five independent assessments are conducted at baseline, EOT, and three follow-ups (Weeks 12, 18, 24). Data collection will occur at each visit, with baseline data collected at the initial visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cardiac Rehabilitation
• Hypersensitivity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	RWJ Cardiac Rehab at East Brunswick	East Brunswick	New Jersey
United States	Rutgers Emotion, Health and Behavior Laboratory Department of Psychology	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall minutes of exercise	Objectively measured exercise (moderate-to-vigorous intensity physical activity mins/day) on both CR and non-CR days.	24 weeks
Secondary	Percent of prescribed cardiac rehabilitation attended.		24 weeks
Secondary	Objectively measured Lifestyle PA (steps/day).		24 weeks