Recruiting

Integrative Mindfulness

Sponsor:

Boston Medical Center

Code:

NCT06106191

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness meditation

Perspectives on pain

Discussion

Study Details

Brief summary:

This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain.

The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment.

The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.

Conditions

Chronic Low-back Pain

Study ID

NCT06106191

Start date

Jul 25, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
  • Willing and able to provide online or telephone informed consent
  • Speak English as the intervention manual is currently written in English

Exclusion Criteria:

  • Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
  • Pregnancy
  • Metastatic cancer
  • Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months

Study Design

Enrollment

350 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness based stress reduction (MBSR) program

Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care.

Interventions

Mindfulness meditation

Ordinary activities like breathing, eating, and walking are turned into a meditation by creating greater awareness of the moment-to-moment sensations, emotions, thoughts and behaviors that arise during these activities.

Perspectives on pain

Understanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior.

Discussion

Discussion on patients' use of mindfulness to work with pain and pain-themed meditations.

Primary outcome measure

  • Pain, Enjoyment, General activity (PEG) composite score [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Natalia Morone, MD MS

617-414-6652Natalia.Morone@bmc.org

Jose Baez, MD

617-272-6848Jose.Baez@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02116

Contacts

Natalia Morone, MD MS

617-414-6652Natalia.Morone@bmc.org

Jose Baez, MD

617-272-6848Jose.Baez@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Mindfulness based stress reduction (MBSR)
  • Machine learning (ML)
  • Biopsychosocial data
  • PEG (Pain, Enjoyment, General activity)
  • Pain interference
  • Pain intensity
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-06-30.