Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06641102

Conditions

Chronic Back Pain

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Self-Guided Program (Tier 1)

Coach Assisted Program (Tier 3)

Standard of Care (SOC)

Study Details

Brief 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

Study ID

NCT06641102

Start date

May 12, 2025

Status verified date

Jun, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 21 to 70
  • Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force
  • Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months.
  • Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week).
  • Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner.
  • Able to use a smartphone

Exclusion Criteria:

  • Back pain associated with compensation or litigation issues as determined by self-report within the past year
  • Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
  • Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
  • Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder
  • Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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).

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.

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.

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 and Locations

Central contacts

Devanshi Patel

Devanshi.Patel@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai - Abilities Research Center

Recruiting

New York, New York, United States, 10029

Contacts

Devanshi Patel

Devanshi.Patel@mountsinai.org

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 18, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-07-18.