Clinical trial NCT04902339: Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain
Official title: Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain Syndrome
Opioid Use
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Blood oxygenation level dependent (BOLD) signaling
timeFrame: From baseline to immediately after the intervention.
Secondary outcomes:
measure: Opioid misuse
timeFrame: From baseline to 3-month follow-up.
measure: Chronic pain symptoms
timeFrame: From baseline to 3-month follow-up.
measure: Opioid dose
timeFrame: From baseline to 3-month follow-up.
measure: Savoring
timeFrame: From baseline to 3-month follow-up.
measure: Distress
timeFrame: From baseline to 3-month follow-up.
measure: Self-transcendence
timeFrame: From baseline to 3-month follow-up.
measure: Pleasant sensation ratio
timeFrame: From baseline to immediately after intervention.
measure: Opioid craving
timeFrame: From baseline to 1-month follow-up.
measure: Positive affect
timeFrame: From baseline to 1-month follow-up.
measure: Pleasure ratings
timeFrame: From baseline to immediately after intervention.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Center on Mindfulness and Integrative Health Intervention Development
state: Utah
Study officials:
affiliation: University of Utah
name: Eric Garland
role: PRINCIPAL_INVESTIGATOR
References: