Going Remote: A Revised Study Protocol for a Pilot Randomized Controlled Trial for Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Adults with spinal cord injury/disorder (SCI/D) experience anxiety more often than the general population. Heart rate variability (HRV) biofeedback training is a possible way to reduce anxiety for people with tetraplegia. Due to the COVID-19 pandemic, the study protocol was modified to ensure the safety of participants and staff by moving the treatment setting to the participant's home.

• 1
  The modified protocol utilizes HIPAA-compliant technologies, such as Zoom, DocuSign, and a commercially available HRV sensor and smartphone application, to facilitate implementation of the intervention at home.
• 2
  Participants are allocated into either a treatment arm or a control arm using the minimization method, balancing the arms based on baseline anxiety levels.
• 3
  The intervention involves eight sessions of self-administered physiological monitoring at home, with the treatment arm completing biofeedback HRV training using a smartphone app.