Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: M.O.R.E. Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. |
Behavioral: Mindfulness-Oriented Recovery Enhancement
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.
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| Active Comparator: Support Group Participants will attend a support group weekly for eight weeks. |
Behavioral: Support Group
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
|
Outcome Measures
Primary Outcome Measures
- Change in opioid misuse [Change from baseline through study completion (9 months post-treatment)]
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 [Change from baseline through study completion (9 months post-treatment)]
Brief Pain Inventory
Secondary Outcome Measures
- Change in opioid craving [Change from baseline through study completion (9 months post-treatment)]
Opioid craving measure from Wasan et al. 2012
- Change in psychological distress [Change from baseline through study completion (9 months post-treatment)]
Depression Anxiety Stress Scale
- Change in opioid dose [Change from baseline through study completion (9 months post-treatment)]
Opioid dose converted into morphine equivalents via standardized equianalgesic tables
Other Outcome Measures
- Change in nonreactivity [Change from baseline through post-treatment (8 weeks from beginning of treatment)]
subscale on Five Facet Mindfulness Questionnaire
- Change in interoceptive awareness [Change from baseline through post-treatment (8 weeks from beginning of treatment)]
Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness
- Change in reinterpretation of pain sensations [Change from baseline through post-treatment (8 weeks from beginning of treatment)]
Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire
- Change in emotion regulation [Change from baseline through post-treatment (8 weeks from beginning of treatment)]
Emotion regulation as evidenced by responses on the Emotion Regulation Task
- Change in positive emotion [Change from baseline through post-treatment (8 weeks from beginning of treatment)]
Positive emotion as evidenced by the PANAS
- Change in cue-reactivity [Change from baseline through post-treatment (8 weeks from beginning of treatment)]
Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure
- Change in attention to positive information [Change from baseline through post-treatment (8 weeks from beginning of treatment)]
Attention to positive information as evidenced by the APNIS
- Change in anhedonia [Change from baseline through study completion (9 months post-treatment)]
Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-60+
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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)
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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:
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Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
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Active suicidality, schizophrenia, psychotic disorder, and/or substance dependence (other than opioid dependence)
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Presence of clinically unstable systemic illness judged to interfere with treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Utah Primary Care Clinics | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Eric Garland, PhD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00078615