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

Not Applicable

Completed

• Conditions: Opioid Use; Chronic Pain Syndrome

• Registration Number: NCT04902339
• Lead Sponsor: University of Utah

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-03
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Status Verified: 2025-04
• Primary Completion: 2025-04-03
• Study Completion: 2025-04-03
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. ≥18 years of age,
2. ability to understand and speak the English language
3. current chronic pain-related diagnosis

Exclusion Criteria

1. mindfulness training experience (e.g., participation in MBSR/MBRP)
2. neurofeedback experience
3. current cancer diagnosis
4. 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)
5. suicidal ideation with a plan in the past week, or a suicide attempt in the past 3 months
6. unwilling, unable, or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
7. communication or cognitive impairment that limits participation in group treatment or study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood oxygenation level dependent (BOLD) signaling	From baseline to immediately after the intervention.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center on Mindfulness and Integrative Health Intervention Development; 🇺🇸 Salt Lake City, Utah, United States