Clinical trial NCT06387290: Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
Official title: Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Prescription Opioid Misuse
Substance-Related Disorders
Pain
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opioid-Related Disorders
Neurologic Manifestations
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2024-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid implementation-effectiveness trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 18 +
* Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment
* Current use of opioids for ≥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 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

Primary outcomes:
measure: Opioid Misuse
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Chronic Pain
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Opioid Dosing
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Opioid Craving
timeFrame: Daily from baseline through month 4
measure: PTSD Symptoms
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Depression
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Generalized Anxiety
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Other outcomes:
measure: Decentering
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Mindful Reappraisal of Pain Sensations
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Savoring
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
measure: Reappraisal
timeFrame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Locations:
city: La Jolla
country: United States
facility: UCSD Health
state: California
city: New Brunswick
country: United States
facility: Rutgers University Primary Care Clinics
state: New Jersey
city: Salt Lake City
country: United States
facility: University of Utah Primary Care Clinics
state: Utah
Study officials:
References: