Recruiting NCT06387290
Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness Oriented Recovery Enhancement, Patient-Centered Chronic Pain Management Visits.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Prescription Opioid Misuse, Substance-Related Disorders, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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. - 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).
Primary outcome measures
- Opioid Misuse [Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)]
- Chronic Pain [Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)]
Secondary outcome measures (6)
- Change in Quality of Life [Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)]
- Opioid Dosing [Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)]
- Opioid Craving [Time frame: Daily from baseline through month 4]
- PTSD Symptoms [Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)]
- Depression [Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)]
- Generalized Anxiety [Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- UCSD Health — La Jolla
- Rutgers University Primary Care Clinics — New Brunswick
- University of Utah Primary Care Clinics — Salt Lake City
Identifiers
NCT: NCT06387290 · 00172836