Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

Not Applicable

Recruiting

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

• Registration Number: NCT06387290
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-29
• Study Start: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2028-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chronic Pain	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)	Change in Chronic pain will be measured from baseline through study completion using the Pain, Enjoyment of Life, and General Activity Scale (PEG). Scoring can be determined in one of two ways: 1. A total sum score from 0 to 30, with higher scores indicating more severe pain and pain-related interference with life and activities; 2. Dividing the sum of responses to all three items by 3 to get the mean score on a scale of 0-10, with higher scores indicating more severe pain and pain-related interference with life and activities.
Opioid Misuse	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)	Opioid misuse as evidenced by triangulated aggregate of self-reported Current Opioid Misuse Measure and/or interview via Addiction Behaviors Checklist and/or urine screen

Secondary Outcome Measures

Name	Time	Method
PTSD Symptoms	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)	PTSD Symptoms will be measured from baseline through study completion using the Posttraumatic Stress Disorder Checklist (PCL-5). Scores range from 0-80, with higher scores indicating overall higher PTSD symptom severity.
Opioid Dosing	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)	Opioid dose will be assessed from baseline through study completion by Timeline Follow Back (TLFB) interview. Opioid dose will be converted to morphine-equivalent using equianalgesic conversions.
Generalized Anxiety	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)	Generalized Anxiety will be measured from baseline through study completion using the Generalized Anxiety Disorder 7 (GAD-7). Scores range from 0-21, with higher scores indicating more severe symptoms of anxiety.
Change in Quality of Life	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)	Change in Quality of Life will be measured from baseline through study completion using the Patient Reported Outcomes Measurement Information System (PROMIS-29) to assess physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Scores range from 4-20 in each domain, with higher scores indicating more impairment in that domain.
Opioid Craving	Daily from baseline through month 4	Opioid craving will be assessed with validated numeric rating scale items (Garland et. al, 2022) delivered by ecological momentary assessment.
Depression	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)	Depression symptoms will be measured from baseline through study completion using the nine-item Patient Health Questionnaire (PHQ-9). Scores range from 0-27, with higher scores indicating more severe symptoms of depression.

Trial Locations

Locations (3)

UCSD Health; 🇺🇸 La Jolla, California, United States

Rutgers University Primary Care Clinics; 🇺🇸 New Brunswick, New Jersey, United States

University of Utah Primary Care Clinics; 🇺🇸 Salt Lake City, Utah, United States