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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Chronic Pain Syndrome; Opioid Use

Treatments: Behavioral: Supportive Psychotherapy; Other: Neurofeedback; Behavioral: Mindfulness-Oriented Recovery Enhancement

Study type: Interventional

Funder types: Other

Identifiers

NCT04902339

IRB_00129302

Details and patient eligibility

About

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).

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 3 patient groups

MORE+NF

Experimental group

Treatment:

Behavioral: Mindfulness-Oriented Recovery Enhancement

Other: Neurofeedback

MORE

Active Comparator group

Treatment:

Behavioral: Mindfulness-Oriented Recovery Enhancement

Supportive Psychotherapy

Active Comparator group

Treatment:

Behavioral: Supportive Psychotherapy