CClinicalTrials.gg
CompletedNCT03298269Updated Dec 10, 2021

Behavioral Interventions for Chronic Pain and Opioid-Related Problems

An interventional study of Mindfulness-Oriented Recovery Enhancement and Supportive Counseling in Chronic Pain, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-10.

Sponsored by University of Utah · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Pain

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    Mindfulness-Oriented Recovery Enhancement

    Behavioral: Mindfulness-Oriented Recovery Enhancement

  • Active comparator
    Supportive Counseling

    Behavioral: Supportive Counseling

Interventions

  • BehavioralMindfulness-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.

    Also known as: MORE

  • BehavioralSupportive Counseling

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

    Also known as: Support Group

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What researchers measure

Primary outcomes

  1. Change in pain symptoms

    Pain severity and interference as measured by the Brief Pain Inventory

    Time frame: Change from baseline through study completion (9 months post-treatment)

  2. Change in aberrant drug-related behaviors

    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

    Time frame: Change from baseline through study completion (9 months post-treatment)

Secondary outcomes

  1. Change in emotional distress

    Distress measured by the Depression, Anxiety, Stress Scale

    Time frame: Change from baseline through study completion (9 months post-treatment)

  2. Change in opioid dose

    Opioid dose converted into morphine equivalents via standardized equianalgesic tables

    Time frame: Change from baseline through study completion (9 months post-treatment)

  3. Change in opioid craving

    Craving measured by visual analogue scale

    Time frame: Change from baseline through study completion (9 months post-treatment)

  4. Change in interoceptive awareness

    Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness

    Time frame: Change from baseline through 8 weeks

  5. Change in reappraisal

    Reappraisal measured by the Emotion Regulation Questionnaire

    Time frame: Change from baseline through 8 weeks

  6. Change in savoring

    Savoring measured by the brief Ways of Savoring checklist

    Time frame: Change from baseline through 8 weeks

  7. Change in meditative experiences

    As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment

    Time frame: Change from baseline through 8 weeks

  8. Change in body sensations

    Change in pleasant, neutral, and unpleasant body sensations as measured by body map

    Time frame: Change from baseline through 8 weeks

Other outcomes

  1. Change in cue-reactivity

    Change in EEG responses during a cue-reactivity task

    Time frame: Change from baseline through 8 weeks

  2. Change in emotion regulation

    Change in EEG responses during an emotion regulation task

    Time frame: Change from baseline through 8 weeks

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Study locations

1 site
  • College of Social Work
    Salt Lake City, Utah 84112, United States
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References and documents

Publications

  • Garland EL, Hudak J, Hanley AW, Nakamura Y. Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. Am Psychol. 2020 Sep;75(6):840-852. doi: 10.1037/amp0000638. PubMed 32915027 ↗
  • Garland EL, Hanley AW, Riquino MR, Reese SE, Baker AK, Salas K, Yack BP, Bedford CE, Bryan MA, Atchley R, Nakamura Y, Froeliger B, Howard MO. Mindfulness-oriented recovery enhancement reduces opioid misuse risk via analgesic and positive psychological mechanisms: A randomized controlled trial. J Consult Clin Psychol. 2019 Oct;87(10):927-940. doi: 10.1037/ccp0000390. PubMed 31556669 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT03298269
Lead sponsor
University of Utah
Responsible party
Eric Garland (Professor, University of Utah) — Principal investigator
First posted
Oct 2, 2017
Start date
Sep 26, 2017
Primary completion
Oct 1, 2020
Completion
Oct 1, 2020
Last update
Dec 10, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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