Back to resultsMindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
Primary Purpose
Chronic Pain, Opioid Use Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement
Support Group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Age 18-60+
- Current back pain diagnosis as determined from ICD-9 codes in claims data (including but not limited to ICD-9 diagnoses 724.x, or 847.x) or current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)
- Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days, and evidence of opioid misuse as indicated by the Current Opioid Misuse Measure
- Willingness to participate in study interventions and assessments
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 substance dependence (other than opioid dependence)
- Presence of clinically unstable systemic illness judged to interfere with treatment
Sites / Locations
- University of Utah Primary Care Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
M.O.R.E.
Support Group
Arm Description
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Participants will attend a support group weekly for eight weeks.
Outcomes
Primary Outcome Measures
Change in opioid misuse
Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen
Change in pain severity and interference
Brief Pain Inventory
Secondary Outcome Measures
Change in opioid craving
Opioid craving measure from Wasan et al. 2012
Change in psychological distress
Depression Anxiety Stress Scale
Change in opioid dose
Opioid dose converted into morphine equivalents via standardized equianalgesic tables
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02602535
Brief Title
Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
Official Title
Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
5. Study Description
Brief Summary
The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic pain to prescription opioid misuse and addiction. The investigators plan to conduct a full scale clinical trial to determine whether MORE (relative to a support group control condition) can reduce symptoms of chronic pain and opioid misuse among patients who are receiving pain management in primary care via long-term opioid analgesic therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M.O.R.E.
Arm Type
Experimental
Arm Description
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Arm Title
Support Group
Arm Type
Active Comparator
Arm Description
Participants will attend a support group weekly for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement
Intervention Description
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.
Intervention Type
Behavioral
Intervention Name(s)
Support Group
Intervention Description
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Primary Outcome Measure Information:
Title
Change in opioid misuse
Description
Opioid misuse 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)
Title
Change in pain severity and interference
Description
Brief Pain Inventory
Time Frame
Change from baseline through study completion (9 months post-treatment)
Secondary Outcome Measure Information:
Title
Change in opioid craving
Description
Opioid craving measure from Wasan et al. 2012
Time Frame
Change from baseline through study completion (9 months post-treatment)
Title
Change in psychological distress
Description
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)
Other Pre-specified Outcome Measures:
Title
Change in nonreactivity
Description
subscale on Five Facet Mindfulness Questionnaire
Time Frame
Change from baseline through post-treatment (8 weeks from beginning of treatment)
Title
Change in interoceptive awareness
Description
Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness
Time Frame
Change from baseline through post-treatment (8 weeks from beginning of treatment)
Title
Change in reinterpretation of pain sensations
Description
Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire
Time Frame
Change from baseline through post-treatment (8 weeks from beginning of treatment)
Title
Change in emotion regulation
Description
Emotion regulation as evidenced by responses on the Emotion Regulation Task
Time Frame
Change from baseline through post-treatment (8 weeks from beginning of treatment)
Title
Change in positive emotion
Description
Positive emotion as evidenced by the PANAS
Time Frame
Change from baseline through post-treatment (8 weeks from beginning of treatment)
Title
Change in cue-reactivity
Description
Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure
Time Frame
Change from baseline through post-treatment (8 weeks from beginning of treatment)
Title
Change in attention to positive information
Description
Attention to positive information as evidenced by the APNIS
Time Frame
Change from baseline through post-treatment (8 weeks from beginning of treatment)
Title
Change in anhedonia
Description
Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia.
Time Frame
Change from baseline through study completion (9 months post-treatment)
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 back pain diagnosis as determined from ICD-9 codes in claims data (including but not limited to ICD-9 diagnoses 724.x, or 847.x) or current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)
Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days, and evidence of opioid misuse as indicated by the Current Opioid Misuse Measure
Willingness to participate in study interventions and assessments
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 substance dependence (other than opioid dependence)
Presence of clinically unstable systemic illness judged to interfere with treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Garland, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Primary Care Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35226053
Citation
Garland EL, Hanley AW, Nakamura Y, Barrett JW, Baker AK, Reese SE, Riquino MR, Froeliger B, Donaldson GW. Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy for Co-occurring Opioid Misuse and Chronic Pain in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):407-417. doi: 10.1001/jamainternmed.2022.0033.
Results Reference
derived
Learn more about this trial
Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
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