Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy

Study Overview
=================
Brief Summary
-----------------
Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.

Detailed Description
-----------------
Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.

Official Title
-----------------
Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms

Conditions
-----------------
Chronic Pain, Opioid Abuse, Unspecified Use

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Oriented Recovery Enhancement
* Behavioral: Conventional Support Group (SG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic pain diagnosis (ICD-9 diagnoses 338.xx) treatment with prescription opioids for > 3 months Exclusion Criteria: prior mindfulness training persons who are experiencing acute opioid withdrawal suicidal ideation psychosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>* MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.<br>|
| Active Comparator: Conventional Support Group (SG)<br> | Behavioral: Conventional Support Group (SG)<br>* The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity, pain functional interference | Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form. | Baseline, immediately following treatment, and at 3 month follow-up | 
| Opioid craving | Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving. | Baseline, immediately following treatment, and at 3 month follow-up | 
| Opioid misuse behaviors | Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure | Baseline, immediately following treatment, and at 3 month follow-up | 
| Well-being | Change in well-being as measured by the WHO-5 | Baseline, immediately following treatment, and at 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attentional bias | Change in attentional bias as measured by a dot probe task | Baseline and immediately following treatment | 
| Psychophysiological cue-reactivity | Change in psychophysiological cue-reactivity | Baseline and immediately following treatment | 
| Emotional response inhibition | Change in emotional response inhibition | Baseline and immediately following treatment | 
| Pain coping strategies | Change in reinterpretation of pain sensations, catastrophizing, and suppression. | Baseline, intervention midpoint, and immediately following treatment | 
| Anhedonia | Change in anhedonia | Baseline and immediately following treatment | 
| Fear of pain | Change in fear of pain | Baseline and immediately following treatment | 
| Mindfulness | Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale | Baseline, intervention midpoint, and immediately following treatment | 
| Positive reappraisal | Change in positive reappraisal | Baseline and immediately following treatment |