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Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602535
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Garland, University of Utah

Study Description
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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
Chronic Pain Opioid Use Disorders Behavioral: Mindfulness-Oriented Recovery Enhancement Behavioral: Support Group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
Study Start Date : January 2016
Actual Primary Completion Date : October 2020
Actual Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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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.
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
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Primary Outcome Measures :
  1. Change in opioid misuse [ Time Frame: 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

  2. Change in pain severity and interference [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    Brief Pain Inventory


Secondary Outcome Measures :
  1. Change in opioid craving [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    Opioid craving measure from Wasan et al. 2012

  2. Change in psychological distress [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    Depression Anxiety Stress Scale

  3. Change in opioid dose [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    Opioid dose converted into morphine equivalents via standardized equianalgesic tables


Other Outcome Measures:
  1. Change in nonreactivity [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
    subscale on Five Facet Mindfulness Questionnaire

  2. Change in interoceptive awareness [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
    Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness

  3. Change in reinterpretation of pain sensations [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
    Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire

  4. Change in emotion regulation [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
    Emotion regulation as evidenced by responses on the Emotion Regulation Task

  5. Change in positive emotion [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
    Positive emotion as evidenced by the PANAS

  6. Change in cue-reactivity [ Time Frame: 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

  7. Change in attention to positive information [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
    Attention to positive information as evidenced by the APNIS

  8. Change in anhedonia [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602535


Locations
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United States, Utah
University of Utah Primary Care Clinics
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Eric Garland, PhD University of Utah
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eric Garland, Ph.D., University of Utah
ClinicalTrials.gov Identifier: NCT02602535    
Other Study ID Numbers: 00078615
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
 Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders