Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

NCT ID: NCT06387290

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2028-05-01

Brief Summary

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The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.

Detailed Description

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Conditions

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Chronic Pain Prescription Opioid Misuse Substance-Related Disorders Pain Narcotic-Related Disorders Chemically-Induced Disorders Mental Disorders Opioid-Related Disorders Neurologic Manifestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Hybrid implementation-effectiveness trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigators, study staff, and statistician will be blinded to treatment condition.

Study Groups

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Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits

Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks, in addition to patient-centered chronic pain management visits led by their primary care provider.

Group Type EXPERIMENTAL

Mindfulness Oriented Recovery Enhancement

Intervention Type BEHAVIORAL

Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative therapeutic approach.

Patient-Centered Chronic Pain Management Visits

Intervention Type BEHAVIORAL

Participant will meet with their primary care provider for patient-centered care and shared decision making while discussing their chronic pain management strategy (e.g., opioid analgesics).

Patient-centered chronic pain management visits

Participants will attend patient-centered chronic pain management visits led by their primary care provider.

Group Type ACTIVE_COMPARATOR

Patient-Centered Chronic Pain Management Visits

Intervention Type BEHAVIORAL

Participant will meet with their primary care provider for patient-centered care and shared decision making while discussing their chronic pain management strategy (e.g., opioid analgesics).

Interventions

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Mindfulness Oriented Recovery Enhancement

Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative therapeutic approach.

Intervention Type BEHAVIORAL

Patient-Centered Chronic Pain Management Visits

Participant will meet with their primary care provider for patient-centered care and shared decision making while discussing their chronic pain management strategy (e.g., opioid analgesics).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 +
* Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment
* Prescribed long-term opioid therapy (≥3 months)
* Score \>=3 on the Pain Enjoyment General Activity scale
* Score \>=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR patient or physician determination that risks of opioid use may outweigh the benefits of opioid use

Exclusion Criteria

* Chronic pain due to a cancer diagnosis
* Active suicidal intent, schizophrenia, psychotic disorder
* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers University

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Eric Garland

Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCSD Health

La Jolla, California, United States

Site Status RECRUITING

Rutgers University Primary Care Clinics

New Brunswick, New Jersey, United States

Site Status RECRUITING

University of Utah Primary Care Clinics

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hannah Pfeffer, MSW

Role: CONTACT

619-500-4668

Thanusha Puvananayagam, MPH

Role: CONTACT

732.235.4341

Facility Contacts

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Hannah Pfeffer, MSW

Role: primary

619-500-4668

Kelly Hendrickson, MS

Role: backup

619-500-4668

Thanusha Puvananayagam, MPH

Role: primary

732-235-4341

Hannah A Pfeffer, MSW

Role: primary

619-500-4668

Other Identifiers

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00172836

Identifier Type: -

Identifier Source: org_study_id

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