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Behavioral Interventions for Chronic Pain and Opioid-Related Problems

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: NCT03298269
Recruitment Status : Active, not recruiting
First Posted : October 2, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Garland, University of Utah

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Mindfulness-Oriented Recovery Enhancement Behavioral: Supportive Counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Mindfulness-Oriented Recovery Enhancement Behavioral: Mindfulness-Oriented Recovery Enhancement
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.
Other Name: MORE

Active Comparator: Supportive Counseling Behavioral: Supportive Counseling
A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.
Other Name: Support Group




Primary Outcome Measures :
  1. Change in pain symptoms [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    Pain severity and interference as measured by the Brief Pain Inventory

  2. Change in aberrant drug-related behaviors [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    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 :
  1. Change in emotional distress [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    Distress measured by the Depression, Anxiety, Stress Scale

  2. 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

  3. Change in opioid craving [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
    Craving measured by visual analogue scale

  4. Change in interoceptive awareness [ Time Frame: Change from baseline through 8 weeks ]
    Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness

  5. Change in reappraisal [ Time Frame: Change from baseline through 8 weeks ]
    Reappraisal measured by the Emotion Regulation Questionnaire

  6. Change in savoring [ Time Frame: Change from baseline through 8 weeks ]
    Savoring measured by the brief Ways of Savoring checklist

  7. Change in meditative experiences [ Time Frame: Change from baseline through 8 weeks ]
    As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment

  8. Change in body sensations [ Time Frame: Change from baseline through 8 weeks ]
    Change in pleasant, neutral, and unpleasant body sensations as measured by body map


Other Outcome Measures:
  1. Change in cue-reactivity [ Time Frame: Change from baseline through 8 weeks ]
    Change in EEG responses during a cue-reactivity task

  2. Change in emotion regulation [ Time Frame: Change from baseline through 8 weeks ]
    Change in EEG responses during an emotion regulation task



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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 substance dependence (other than opioid dependence)
  • Opioid misuse as determined by Current Opioid Misuse Measure

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): NCT03298269


Locations
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United States, Utah
College of Social Work
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Garland, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03298269    
Other Study ID Numbers: 1618
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms