Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

Utah System of Higher Education (USHE)

Status and phase: Enrolling; Phase 3

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

Treatments: Behavioral: Patient-Centered Chronic Pain Management Visits; Behavioral: Mindfulness Oriented Recovery Enhancement

Study type: Interventional

Funder types: Other

Identifiers

NCT06387290

00172836

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Oriented Recovery Enhancement

Behavioral: Patient-Centered Chronic Pain Management Visits

Patient-centered chronic pain management visits

Active Comparator group

Description:

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

Treatment:

Behavioral: Patient-Centered Chronic Pain Management Visits