Behavioral Interventions for Chronic Pain and Opioid-Related Problems

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Mindfulness-Oriented Recovery Enhancement; Behavioral: Supportive Counseling

• Registration Number: NCT03298269
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-26
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-02
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Age 18-60+
• Current chronic pain condition
• Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Oriented Recovery Enhancement	Mindfulness-Oriented Recovery Enhancement	-
Supportive Counseling	Supportive Counseling	-

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
Change in opioid craving	Change from baseline through study completion (9 months post-treatment)	Craving measured by visual analogue scale
Change in interoceptive awareness	Change from baseline through 8 weeks	Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness
Change in emotional distress	Change from baseline through study completion (9 months post-treatment)	Distress measured by the Depression, Anxiety, Stress Scale
Change in opioid dose	Change from baseline through study completion (9 months post-treatment)	Opioid dose converted into morphine equivalents via standardized equianalgesic tables
Change in savoring	Change from baseline through 8 weeks	Savoring measured by the brief Ways of Savoring checklist
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
Change in reappraisal	Change from baseline through 8 weeks	Reappraisal measured by the Emotion Regulation Questionnaire
Change in body sensations	Change from baseline through 8 weeks	Change in pleasant, neutral, and unpleasant body sensations as measured by body map

Trial Locations

Locations (1)

College of Social Work; 🇺🇸 Salt Lake City, Utah, United States