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

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).

Study Overview

• Status: Recruiting
• Conditions: Opioid Use; Chronic Pain Syndrome
• Intervention / Treatment: Behavioral: Mindfulness-Oriented Recovery Enhancement; Other: Neurofeedback; Behavioral: Supportive Psychotherapy

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 8015813826; Email: Utahpainstudy@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Center on Mindfulness and Integrative Health Intervention Development
      • Contact: Research Coordinator; Email: eric.garland@socwk.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
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 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.
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.

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Eric Garland, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Estimated): August 30, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: IRB_00129302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No