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Behavioral Interventions for Chronic Pain and Opioid-Related Problems

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT03298269
Collaborator
(none)
95
Enrollment
1
Location
2
Arms
36.2
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Oriented Recovery Enhancement
  • Behavioral: Supportive Counseling
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 26, 2017
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • Support Group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in pain symptoms [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 [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 [Change from baseline through study completion (9 months post-treatment)]

      Distress measured by the Depression, Anxiety, Stress Scale

    2. Change in opioid dose [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 [Change from baseline through study completion (9 months post-treatment)]

      Craving measured by visual analogue scale

    4. Change in interoceptive awareness [Change from baseline through 8 weeks]

      Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness

    5. Change in reappraisal [Change from baseline through 8 weeks]

      Reappraisal measured by the Emotion Regulation Questionnaire

    6. Change in savoring [Change from baseline through 8 weeks]

      Savoring measured by the brief Ways of Savoring checklist

    7. Change in meditative experiences [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 [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 [Change from baseline through 8 weeks]

      Change in EEG responses during a cue-reactivity task

    2. Change in emotion regulation [Change from baseline through 8 weeks]

      Change in EEG responses during an emotion regulation task

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 College of Social Work Salt Lake City Utah United States 84112

    Sponsors and Collaborators

    • University of Utah

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric Garland, Professor, University of Utah
    ClinicalTrials.gov Identifier:
    NCT03298269
    Other Study ID Numbers:
    • 1618
    First Posted:
    Oct 2, 2017
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chronic Pain

    Study Results

    No Results Posted as of Dec 10, 2021