Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain

Study Overview
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Brief Summary
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The primary aim of this pilot trial is to enhance the efficacy of the Mindfulness-Oriented Recovery Enhancement (MORE) intervention by adding neurofeedback (NF) of the Orbitofrontal Cortex (OFC) as an adjunct to the savoring component of MORE. We hypothesize that the use of NF to train OFC responses during savoring will amplify patients' ability to savor and thereby increase brain responsivity to natural rewards; such enhanced reward responding will in turn be associated with improvements in clinical outcomes (e.g., pain, analgesic use).

Official Title
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Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain

Conditions
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Chronic Pain Syndrome, Opioid Use

Intervention / Treatment
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* Behavioral: Mindfulness-Oriented Recovery Enhancement
* Other: Neurofeedback
* Behavioral: Supportive Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age, ability to understand and speak the English language current chronic pain-related diagnosis Exclusion Criteria: mindfulness training experience (e.g., participation in MBSR/MBRP) neurofeedback experience current cancer diagnosis having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication) suicidal ideation with a plan in the past week, or a suicide attempt in the past 3 months unwilling, unable, or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier) communication or cognitive impairment that limits participation in group treatment or study procedures

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORE+NF<br> | Behavioral: Mindfulness-Oriented Recovery Enhancement<br>* 8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills.<br>Other: Neurofeedback<br>* Near-infrared spectroscopy neurofeedback during savoring practice.<br>|
| Active Comparator: MORE<br> | Behavioral: Mindfulness-Oriented Recovery Enhancement<br>* 8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills.<br>|
| Active Comparator: Supportive Psychotherapy<br> | Behavioral: Supportive Psychotherapy<br>* 8 weeks of supportive, process-oriented psychotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygenation level dependent (BOLD) signaling | Changes in blood oxygenation levels to reward cues will be assessed, and planned comparisons will be performed between subjects receiving MORE+NF vs the control conditions. | From baseline to immediately after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid misuse | Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68) | From baseline to 3-month follow-up. | 
| Chronic pain symptoms | Chronic pain symptoms will be measured with the Brief Pain Inventory, where higher scores indicate worse pain (min 0, max 10). | From baseline to 3-month follow-up. | 
| Opioid dose | Opioid dose as assessed with Timeline Followback Procedure | From baseline to 3-month follow-up. | 
| Savoring | Savoring as measured by the Brief Savoring Inventory, with higher scores indicating higher savoring (min 4, max 20) | From baseline to 3-month follow-up. | 
| Distress | Emotional distress measured by the Depression Anxiety Stress Scale-21, with higher scores indicating higher distress (min 0, max 63) | From baseline to 3-month follow-up. | 
| Self-transcendence | Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65) | From baseline to 3-month follow-up. | 
| Pleasant sensation ratio | Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations. | From baseline to immediately after intervention. | 
| Opioid craving | Opioid craving measured by numeric rating scale, with higher scores indicating worse craving (min 0, max 10) | From baseline to 1-month follow-up. | 
| Positive affect | Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10) | From baseline to 1-month follow-up. | 
| Pleasure ratings | Positive affect measured by numeric rating scale, with higher scores indicating higher pleasure (min 0, max 10) | From baseline to immediately after intervention. |