Back to resultsNear-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain
Primary Purpose
Chronic Pain Syndrome, Opioid Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement
Neurofeedback
Supportive Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain Syndrome
Eligibility Criteria
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
Sites / Locations
- Center on Mindfulness and Integrative Health Intervention DevelopmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
MORE+NF
MORE
Supportive Psychotherapy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Opioid misuse
Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)
Chronic pain symptoms
Chronic pain symptoms will be measured with the Brief Pain Inventory, where higher scores indicate worse pain (min 0, max 10).
Opioid dose
Opioid dose as assessed with Timeline Followback Procedure
Savoring
Savoring as measured by the Brief Savoring Inventory, with higher scores indicating higher savoring (min 4, max 20)
Distress
Emotional distress measured by the Depression Anxiety Stress Scale-21, with higher scores indicating higher distress (min 0, max 63)
Self-transcendence
Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)
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.
Opioid craving
Opioid craving measured by numeric rating scale, with higher scores indicating worse craving (min 0, max 10)
Positive affect
Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10)
Pleasure ratings
Positive affect measured by numeric rating scale, with higher scores indicating higher pleasure (min 0, max 10)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04902339
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Syndrome, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MORE+NF
Arm Type
Experimental
Arm Title
MORE
Arm Type
Active Comparator
Arm Title
Supportive Psychotherapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement
Intervention Description
8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills.
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Intervention Description
Near-infrared spectroscopy neurofeedback during savoring practice.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
8 weeks of supportive, process-oriented psychotherapy.
Primary Outcome Measure Information:
Title
Blood oxygenation level dependent (BOLD) signaling
Description
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.
Time Frame
From baseline to immediately after the intervention.
Secondary Outcome Measure Information:
Title
Opioid misuse
Description
Scores on Current Opioid Misuse Measure, with higher scores indicating higher opioid misuse (min 0, max 68)
Time Frame
From baseline to 3-month follow-up.
Title
Chronic pain symptoms
Description
Chronic pain symptoms will be measured with the Brief Pain Inventory, where higher scores indicate worse pain (min 0, max 10).
Time Frame
From baseline to 3-month follow-up.
Title
Opioid dose
Description
Opioid dose as assessed with Timeline Followback Procedure
Time Frame
From baseline to 3-month follow-up.
Title
Savoring
Description
Savoring as measured by the Brief Savoring Inventory, with higher scores indicating higher savoring (min 4, max 20)
Time Frame
From baseline to 3-month follow-up.
Title
Distress
Description
Emotional distress measured by the Depression Anxiety Stress Scale-21, with higher scores indicating higher distress (min 0, max 63)
Time Frame
From baseline to 3-month follow-up.
Title
Self-transcendence
Description
Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)
Time Frame
From baseline to 3-month follow-up.
Title
Pleasant sensation ratio
Description
Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations.
Time Frame
From baseline to immediately after intervention.
Title
Opioid craving
Description
Opioid craving measured by numeric rating scale, with higher scores indicating worse craving (min 0, max 10)
Time Frame
From baseline to 1-month follow-up.
Title
Positive affect
Description
Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10)
Time Frame
From baseline to 1-month follow-up.
Title
Pleasure ratings
Description
Positive affect measured by numeric rating scale, with higher scores indicating higher pleasure (min 0, max 10)
Time Frame
From baseline to immediately after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
8015813826
Email
Utahpainstudy@utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Garland
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Mindfulness and Integrative Health Intervention Development
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Email
eric.garland@socwk.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain
We'll reach out to this number within 24 hrs