NCT06641102

Healing Track Clinical Trial

Healing Track Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP). The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for CBP. This study will assess changes in pain intensity from PRT intervention compared to a standard of care (SOC) control group in adults with CBP. SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual. The research team plans to enroll 180 participants who will be randomized into one of three groups.

Conditions

• Chronic Back Pain

Interventions

Type	Name	Description
OTHER	Self-Guided Program (Tier 1)	The study intervention is a smartphone application. Tier 1: self-guided program, includes videos, guided meditations, and worksheets that are delivered to users in 10 different topical modules. Two modules are delivered per week, with email reminders. It will emphasize that PRT is a practice that requires users to come back to the material regularly to help retrain the brain often (just like how you need to practice and complete exercises between PT sessions).
OTHER	Coach Assisted Program (Tier 3)	The study intervention is a smartphone application. Tier 3: one-on-one coaching program that sets users up with trained PRT coaches who will walk them through the program individually. Users will meet with the assigned coaches once per week for an hour-long Zoom-hosted session that covers the same information as Tier 1, however in a completely personal and individualized way, focusing on the content that is most relevant for the user/patient at the time of the session. Tier 3 users will also receive materials from their coaches (e.g. videos, meditations, etc.) to support their own practice between session.
OTHER	Standard of Care (SOC)	SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual.

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-10-15
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States