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Completed

NCT Number: NCT03298269

Behavioral Interventions for Chronic Pain and Opioid-Related Problems

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Social Work

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Oriented Recovery Enhancement

Behavioral

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

Supportive Counseling

Behavioral

A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.

Other names: Support Group

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2017
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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