NCT03298269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

3 years

First QC Date

September 26, 2017

Last Update Submit

December 8, 2021

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Change in emotional distress

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

  • Change in opioid dose

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

  • Change in opioid craving

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

  • Change in interoceptive awareness

    Change from baseline through 8 weeks

  • Change in reappraisal

    Change from baseline through 8 weeks

  • +3 more secondary outcomes

Other Outcomes (2)

  • Change in cue-reactivity

    Change from baseline through 8 weeks

  • Change in emotion regulation

    Change from baseline through 8 weeks

Study Arms (2)

Mindfulness-Oriented Recovery Enhancement

EXPERIMENTAL
Behavioral: Mindfulness-Oriented Recovery Enhancement

Supportive Counseling

ACTIVE COMPARATOR
Behavioral: Supportive Counseling

Interventions

Mindfulness-Oriented Recovery EnhancementBEHAVIORAL

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
Mindfulness-Oriented Recovery Enhancement
Supportive CounselingBEHAVIORAL

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

Also known as: Support Group
Supportive Counseling

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Social Work

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

  • 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.

    PMID: 32915027DERIVED

  • 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.

    PMID: 31556669DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 2, 2017

Study Start

September 26, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

December 10, 2021

Record last verified: 2021-12

Locations

US(1)