Behavioral Interventions for Chronic Pain and Opioid-Related Problems

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.

Official Title
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Behavioral Interventions for Chronic Pain and Opioid-Related Problems

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Mindfulness-Oriented Recovery Enhancement
* Behavioral: Supportive Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60+ Current chronic pain condition Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days Exclusion Criteria: Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence) Opioid misuse as determined by Current Opioid Misuse Measure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Oriented Recovery Enhancement<br> | Behavioral: Mindfulness-Oriented Recovery Enhancement<br>* Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.<br>* Other names: MORE;|
| Active Comparator: Supportive Counseling<br> | Behavioral: Supportive Counseling<br>* A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.<br>* Other names: Support Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain symptoms | Pain severity and interference as measured by the Brief Pain Inventory | Change from baseline through study completion (9 months post-treatment) | 
| Change in aberrant drug-related behaviors | Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen | Change from baseline through study completion (9 months post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in emotional distress | Distress measured by the Depression, Anxiety, Stress Scale | Change from baseline through study completion (9 months post-treatment) | 
| Change in opioid dose | Opioid dose converted into morphine equivalents via standardized equianalgesic tables | Change from baseline through study completion (9 months post-treatment) | 
| Change in opioid craving | Craving measured by visual analogue scale | Change from baseline through study completion (9 months post-treatment) | 
| Change in interoceptive awareness | Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness | Change from baseline through 8 weeks | 
| Change in reappraisal | Reappraisal measured by the Emotion Regulation Questionnaire | Change from baseline through 8 weeks | 
| Change in savoring | Savoring measured by the brief Ways of Savoring checklist | Change from baseline through 8 weeks | 
| Change in meditative experiences | As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment | Change from baseline through 8 weeks | 
| Change in body sensations | Change in pleasant, neutral, and unpleasant body sensations as measured by body map | Change from baseline through 8 weeks |