Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06387290

Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

Led by University of Utah · Updated on 2026-02-03

300

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

R

Rutgers University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) combined with patient-centered chronic pain management visits to reduce chronic pain, improve quality of life, and lower opioid-related harms in adults with chronic pain who are on long-term opioid therapy. This Phase 3 trial focuses on managing chronic pain and opioid misuse in a primary care setting. Participants are randomly assigned to one of two groups: one group attends weekly MORE behavioral therapy sessions for eight weeks alongside patient-centered chronic pain management visits with their primary care provider, while the other group receives only the patient-centered chronic pain management visits. MORE integrates mindfulness training, cognitive reappraisal, and positive psychology into a group therapy format. Throughout the study, participants will be assessed at 3, 6, 9, and 12 months for changes in opioid misuse, chronic pain levels, quality of life, opioid dosing, opioid craving, PTSD symptoms, depression, and anxiety. The study uses double masking and includes various evaluations to monitor these outcomes over time. Participants can expect regular follow-up visits and questionnaires as part of their involvement.

CONDITIONS

Brief Title

Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Current diagnosis of chronic pain lasting at least 3 months as determined by a physician
  • Prescribed long-term opioid therapy for 3 months or more
  • Score of 3 or higher on the Pain Enjoyment General Activity scale
  • Score of 9 or higher on the Current Opioid Misuse Measure OR history of psychiatric or substance use disorder OR benzodiazepine use OR history of overdose OR patient or physician determination that opioid risks may outweigh benefits
Not Eligible

You will not qualify if you...

  • Chronic pain caused by cancer
  • Active suicidal intent, schizophrenia, or psychotic disorder
  • Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants attend weekly Mindfulness-Oriented Recovery Enhancement (MORE) group sessions for eight weeks, and all participants meet with their primary care provider for patient-centered chronic pain management visits.

Weekly visits for 8 weeks

Follow-up

Duration - Up to 12 months

Participants are followed to assess changes in opioid misuse, chronic pain, quality of life, PTSD symptoms, depression, and anxiety at multiple timepoints after treatment.

Visits at 3, 6, 9, and 12 months

Trial Site Locations

Total: 3 locations

1

UCSD Health

La Jolla, California, United States, 92037

Actively Recruiting

2

Rutgers University Primary Care Clinics

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

3

University of Utah Primary Care Clinics

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

H

Hannah Pfeffer, MSW

T

Thanusha Puvananayagam, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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