RECRUITING

Behavioral Exposure for Introceptive Tolerance RCT

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-03
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05398276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥ 40 years of age
  2. 2. Elevated exercise anxiety (score of ≥ 30 on ESQ-18)
  3. 3. Low active (\< 90 min self-reported moderate-to-vigorous intensity physical activity/day in past three months)
  4. 4. Medically approved cardiac rehabilitation
  5. 5. English proficiency
  1. 1. Evidence of cognitive impairment (≤ 23 on Montreal Cognitive Assessment; MoCA)
  2. 2. Severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevents safe or adequate participation
  3. 3. Expectation that patient will not live through study periods

Contacts and Locations

Study Contact

Samantha G Farris, PhD
CONTACT
(845) 445-2174
samantha.farris@rutgers.edu
Mindy Kibbey, MS
CONTACT
(732) 289-5036
mmk192@psych.rutgers.edu

Study Locations (Sites)

RWJ Cardiac Rehab at East Brunswick
East Brunswick, New Jersey, 08816
United States
Rutgers Emotion, Health and Behavior Laboratory Department of Psychology
New Brunswick, New Jersey, 08901
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-03
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2022-05-03
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Exercise Sensitivity
  • Introceptive Exposure
  • Anxiety
  • Cardiac Rehabilitation