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

NCT04902339 | Completed

• 1 other identifier: IRB_00129302
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain Syndrome; Opioid Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Opioid misuse

  From baseline to 3-month follow-up.

• Chronic pain symptoms

  From baseline to 3-month follow-up.

• Opioid dose

  From baseline to 3-month follow-up.

• Savoring

  From baseline to 3-month follow-up.

• Distress

  From baseline to 3-month follow-up.

Study Arms (3)

MORE+NF

EXPERIMENTAL

Behavioral: Mindfulness-Oriented Recovery Enhancement; Other: Neurofeedback

MORE

ACTIVE COMPARATOR

Behavioral: Mindfulness-Oriented Recovery Enhancement

Supportive Psychotherapy

ACTIVE COMPARATOR

Behavioral: Supportive Psychotherapy

Interventions

Mindfulness-Oriented Recovery Enhancement BEHAVIORAL

8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills.

MORE; MORE+NF

Neurofeedback OTHER

Near-infrared spectroscopy neurofeedback during savoring practice.

MORE+NF

Supportive Psychotherapy BEHAVIORAL

8 weeks of supportive, process-oriented psychotherapy.

Supportive Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Center on Mindfulness and Integrative Health Intervention Development

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Neurofeedback

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Eric Garland

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 26, 2021
• Study Start: April 3, 2021
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)