Back to resultsBehavioral Interventions for Chronic Pain and Opioid-Related Problems
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement
Supportive Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Age 18-60+
- Current chronic pain condition
- Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days
Exclusion Criteria:
- Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
- Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)
- Opioid misuse as determined by Current Opioid Misuse Measure
Sites / Locations
- College of Social Work
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-Oriented Recovery Enhancement
Supportive Counseling
Arm Description
Outcomes
Primary Outcome Measures
Change in pain symptoms
Pain severity and interference as measured by the Brief Pain Inventory
Change in aberrant drug-related behaviors
Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen
Secondary Outcome Measures
Change in emotional distress
Distress measured by the Depression, Anxiety, Stress Scale
Change in opioid dose
Opioid dose converted into morphine equivalents via standardized equianalgesic tables
Change in opioid craving
Craving measured by visual analogue scale
Change in interoceptive awareness
Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness
Change in reappraisal
Reappraisal measured by the Emotion Regulation Questionnaire
Change in savoring
Savoring measured by the brief Ways of Savoring checklist
Change in meditative experiences
As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment
Change in body sensations
Change in pleasant, neutral, and unpleasant body sensations as measured by body map
Full Information
NCT ID
NCT03298269
First Posted
September 26, 2017
Last Updated
December 8, 2021
Sponsor
University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT03298269
Brief Title
Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Official Title
Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
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 purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Oriented Recovery Enhancement
Arm Type
Experimental
Arm Title
Supportive Counseling
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement
Other Intervention Name(s)
MORE
Intervention Description
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Counseling
Other Intervention Name(s)
Support Group
Intervention Description
A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.
Primary Outcome Measure Information:
Title
Change in pain symptoms
Description
Pain severity and interference as measured by the Brief Pain Inventory
Time Frame
Change from baseline through study completion (9 months post-treatment)
Title
Change in aberrant drug-related behaviors
Description
Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen
Time Frame
Change from baseline through study completion (9 months post-treatment)
Secondary Outcome Measure Information:
Title
Change in emotional distress
Description
Distress measured by the Depression, Anxiety, Stress Scale
Time Frame
Change from baseline through study completion (9 months post-treatment)
Title
Change in opioid dose
Description
Opioid dose converted into morphine equivalents via standardized equianalgesic tables
Time Frame
Change from baseline through study completion (9 months post-treatment)
Title
Change in opioid craving
Description
Craving measured by visual analogue scale
Time Frame
Change from baseline through study completion (9 months post-treatment)
Title
Change in interoceptive awareness
Description
Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness
Time Frame
Change from baseline through 8 weeks
Title
Change in reappraisal
Description
Reappraisal measured by the Emotion Regulation Questionnaire
Time Frame
Change from baseline through 8 weeks
Title
Change in savoring
Description
Savoring measured by the brief Ways of Savoring checklist
Time Frame
Change from baseline through 8 weeks
Title
Change in meditative experiences
Description
As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment
Time Frame
Change from baseline through 8 weeks
Title
Change in body sensations
Description
Change in pleasant, neutral, and unpleasant body sensations as measured by body map
Time Frame
Change from baseline through 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in cue-reactivity
Description
Change in EEG responses during a cue-reactivity task
Time Frame
Change from baseline through 8 weeks
Title
Change in emotion regulation
Description
Change in EEG responses during an emotion regulation task
Time Frame
Change from baseline through 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-60+
Current chronic pain condition
Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days
Exclusion Criteria:
Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)
Opioid misuse as determined by Current Opioid Misuse Measure
Facility Information:
Facility Name
College of Social Work
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32915027
Citation
Garland EL, Hudak J, Hanley AW, Nakamura Y. Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. Am Psychol. 2020 Sep;75(6):840-852. doi: 10.1037/amp0000638.
Results Reference
derived
PubMed Identifier
31556669
Citation
Garland EL, Hanley AW, Riquino MR, Reese SE, Baker AK, Salas K, Yack BP, Bedford CE, Bryan MA, Atchley R, Nakamura Y, Froeliger B, Howard MO. Mindfulness-oriented recovery enhancement reduces opioid misuse risk via analgesic and positive psychological mechanisms: A randomized controlled trial. J Consult Clin Psychol. 2019 Oct;87(10):927-940. doi: 10.1037/ccp0000390.
Results Reference
derived
Learn more about this trial
Behavioral Interventions for Chronic Pain and Opioid-Related Problems
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