Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol.

Area of Science:

• Behavioral medicine
• Cardiac rehabilitation
• Psychological interventions

Background:

• Exercise anxiety is a novel mechanism linked to poor adherence to exercise and physical activity.
• Behavioral Exposure For Interoceptive Tolerance (BE-FIT) is a manualized, values-based exposure intervention targeting exercise anxiety.
• BE-FIT is delivered as a supplement to outpatient cardiac rehabilitation (CR).

Purpose of the Study:

• To test the efficacy of BE-FIT compared to a Health Education Control (HEC) intervention.
• To evaluate the impact of BE-FIT on exercise and physical activity outcomes.
• To examine the mechanisms of change, specifically reductions in exercise anxiety.

Main Methods:

• A Stage II randomized controlled trial (RCT) was conducted.
• 146 adults (≥40 years) cleared for CR, low active, and with elevated exercise anxiety were recruited.
• Outcomes were assessed at end-of-treatment (EOT) and follow-ups (Weeks 12, 18, 24).

Main Results:

• Primary hypothesis: BE-FIT will lead to higher overall exercise and lifestyle physical activity levels compared to HEC at EOT and follow-ups.
• Secondary hypothesis: BE-FIT will result in greater reductions in exercise anxiety at EOT and Week 12.
• Exploratory hypothesis: Reductions in exercise anxiety will mediate the effect of BE-FIT on activity outcomes.

Conclusions:

• The study is expected to yield knowledge on BE-FIT's efficacy and mechanisms of action.
• Understanding how and why BE-FIT is effective is a key goal.
• The findings aim to enhance collective knowledge and reproducibility in behavior change research.