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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness-Oriented Recovery Enhancement; Behavioral: Supportive Counseling

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • College of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain symptoms	Pain severity and interference as measured by the Brief Pain Inventory	Change from baseline through study completion (9 months post-treatment)
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	Change from baseline through study completion (9 months post-treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in opioid dose	Opioid dose converted into morphine equivalents via standardized equianalgesic tables	Change from baseline through study completion (9 months post-treatment)
Change in emotional distress	Distress measured by the Depression, Anxiety, Stress Scale	Change from baseline through study completion (9 months post-treatment)
Change in opioid craving	Craving measured by visual analogue scale	Change from baseline through study completion (9 months post-treatment)
Change in interoceptive awareness	Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness	Change from baseline through 8 weeks
Change in reappraisal	Reappraisal measured by the Emotion Regulation Questionnaire	Change from baseline through 8 weeks
Change in savoring	Savoring measured by the brief Ways of Savoring checklist	Change from baseline through 8 weeks
Change in meditative experiences	As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment	Change from baseline through 8 weeks
Change in body sensations	Change in pleasant, neutral, and unpleasant body sensations as measured by body map	Change from baseline through 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cue-reactivity	Change in EEG responses during a cue-reactivity task	Change from baseline through 8 weeks
Change in emotion regulation	Change in EEG responses during an emotion regulation task	Change from baseline through 8 weeks

Collaborators and Investigators

• Sponsor: University of Utah

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 26, 2017
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (ACTUAL): October 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No