Healing Track Clinical Trial

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06641102
Status
Recruiting
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Conditions

  • Chronic Back Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Self-Guided Program (Tier 1) — OTHER
    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).
  • Coach Assisted Program (Tier 3) — OTHER
    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.
  • Standard of Care (SOC) — OTHER
    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.

Study Details

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.

Key Dates

Start date
May 12, 2025
Status verified
Jun 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Chronic Back Pain in Self-Guided Program
    Participants with CBP in a self-guided program that includes videos, guided meditations, and worksheets that are delivered to users in 10 different topical modules.
  • Experimental: Participants with Chronic Back Pain in Coach Assisted Program
    Participants with CBP in a one-on-one coaching program that sets users up with trained PRT coaches who will walk them through the program individually.
  • Active Comparator: Participants receiving Standard of Care
    Standard of care (SOC) control group in adults with CBP.

Primary Outcome Measure

Brief Pain Inventory Short Form [ Time Frame: <Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount Sinai - Abilities Research CenterNew YorkNew York10029
David Putrino (PRINCIPAL_INVESTIGATOR)

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By research site
Icahn School of Medicine at Mount Sinai - Abilities Research Center· New York, NY

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