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Completed

NCT Number: NCT04902339

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).

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Key information

Conditions

Chronic Pain Syndrome Opioid Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center on Mindfulness and Integrative Health Intervention Development

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Oriented Recovery Enhancement

Behavioral

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

Neurofeedback

Other

Near-infrared spectroscopy neurofeedback during savoring practice.

supportive psychotherapy

Behavioral

8 weeks of supportive, process-oriented psychotherapy.

Primary outcomes

  1. Blood oxygenation level dependent (BOLD) signaling

    Time frame: 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 outcomes

  1. Opioid misuse

    Time frame: From baseline to 3-month follow-up.

    Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)

  2. Chronic pain symptoms

    Time frame: 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).

  3. Opioid dose

    Time frame: From baseline to 3-month follow-up.

    Opioid dose as assessed with Timeline Followback Procedure

  4. Savoring

    Time frame: 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)

  5. Distress

    Time frame: 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)

  6. Self-transcendence

    Time frame: 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)

  7. Pleasant sensation ratio

    Time frame: 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.

  8. Opioid craving

    Time frame: From baseline to 1-month follow-up.

    Opioid craving measured by numeric rating scale, with higher scores indicating worse craving (min 0, max 10)

  9. Positive affect

    Time frame: 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)

  10. Pleasure ratings

    Time frame: From baseline to immediately after intervention.

    Positive affect measured by numeric rating scale, with higher scores indicating higher pleasure (min 0, max 10)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 26, 2021
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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