Chronic Pain SyndromeNCT04902339
Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain
A study testing Mindfulness-Oriented Recovery Enhancement, Neurofeedback and Supportive Psychotherapy in people with Chronic Pain Syndrome and Opioid Use, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain Syndrome, Opioid Use
- What is being tested?
- Mindfulness-Oriented Recovery Enhancement, Neurofeedback and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2021to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age,
- ability to understand and speak the English language
- current chronic pain-related diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112
About this study
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
- Being tested
- Mindfulness-Oriented Recovery Enhancement, Neurofeedback, Supportive Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Oriented Recovery EnhancementBehavioural
8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills.
NeurofeedbackOther
Near-infrared spectroscopy neurofeedback during savoring practice.
Supportive PsychotherapyBehavioural
8 weeks of supportive, process-oriented psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| MORE+NF | Experimental | Not described Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement; Other: Neurofeedback |
| MORE | Active comparator | Not described Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement |
| Supportive Psychotherapy | Active comparator | Not described Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to immediately after the intervention.
Secondary outcomes (10)
Opioid misuse
Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)
Measured: 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).
Measured: From baseline to 3-month follow-up.
Opioid dose
Opioid dose as assessed with Timeline Followback Procedure
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline to immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start3 Apr 2021
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Garland, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902339
- Sponsor's protocol ID
- IRB_00129302
- Status last verified
- Apr 2025
- First submitted
- 20 May 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain
- ClinicalTrials.gov ID
- NCT04902339
- Acronym / sponsor ID
- IRB_00129302
- Conditions
- Chronic Pain Syndrome, Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age,
- ability to understand and speak the English language
- current chronic pain-related diagnosis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills. | Behavioural | MORE, MORE+NF |
| NeurofeedbackNear-infrared spectroscopy neurofeedback during savoring practice. | Other | MORE+NF |
| Supportive Psychotherapy8 weeks of supportive, process-oriented psychotherapy. | Behavioural | Supportive Psychotherapy |
Primary outcome
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.
10 secondary outcomes
Opioid misuse
Time frame: From baseline to 3-month follow-up.
Chronic pain symptoms
Time frame: From baseline to 3-month follow-up.
Opioid dose
Time frame: From baseline to 3-month follow-up.
Savoring
Time frame: From baseline to 3-month follow-up.
Distress
Time frame: From baseline to 3-month follow-up.
Self-transcendence
Time frame: From baseline to 3-month follow-up.
Pleasant sensation ratio
Time frame: From baseline to immediately after intervention.
Opioid craving
Time frame: From baseline to 1-month follow-up.
Positive affect
Time frame: From baseline to 1-month follow-up.
Pleasure ratings
Time frame: From baseline to immediately after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Garland principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Oriented Recovery Enhancement, Neurofeedback and Supportive Psychotherapy in people with Chronic Pain Syndrome and Opioid Use, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygenation level dependent (BOLD) signaling (time frame: From baseline to immediately after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.