NCT02935621

Brief Summary

The central aim of this proposed study is to test a multimodal, mindfulness-oriented intervention designed to disrupt the risk chain leading to prescription opioid dose escalation, opioid misuse and opioid addiction, which are mounting threats to active duty service members and Veterans with chronic pain conditions, who may develop disordered opioid use as a consequence of long-term opioid pharmacotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

5.7 years

First QC Date

October 11, 2016

Last Update Submit

March 19, 2023

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

  • Change in opioid misuse

    Change in Current Opioid Misuse Measure from baseline through study completion (6 months post-treatment). Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen

    Baseline, and through 6 months post-treatment

  • Change in pain severity and interference

    Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment)

    Baseline, and through 6 months post-treatment

Secondary Outcomes (5)

  • Change in opioid craving

    Baseline, during treatment

  • Change in psychological distress

    Baseline, and through 6 months post-treatment

  • Change in opioid dose (in morphine equivalents)

    Baseline, during treatment, and through 6 months post-treatment

  • Change in post-traumatic stress

    Baseline, and through 6 months post-treatment

  • Change in resilience

    Baseline, and through 6 months post-treatment

Other Outcomes (9)

  • Change in nonreactivity

    Baseline, and through 6 months post-treatment

  • Change in reinterpretation of pain sensations

    Baseline, and through 6 months post-treatment

  • Change in emotion regulation

    Baseline, post-treatment (8 weeks from beginning of treatment)

  • +6 more other outcomes

Study Arms (2)

Mindfulness-Oriented Recovery Enhancement

EXPERIMENTAL

Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.

Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

Support Group

ACTIVE COMPARATOR

Participants will attend a support group weekly for eight weeks.

Behavioral: Support Group

Interventions

Mindfulness-Oriented Recovery Enhancement (MORE)BEHAVIORAL

Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.

Mindfulness-Oriented Recovery Enhancement
Support GroupBEHAVIORAL

A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Support Group

Eligibility Criteria

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

You may qualify if:

  • men/women ≥18 years of age
  • ability to understand and speak the English language
  • current chronic pain diagnosis (including but not limited to ICD-9 diagnoses 338.0, 338.2xx, 338.
  • current use of prescription opioids for \>3 consecutive months.

You may not qualify if:

  • Mindfulness training experience (participation in MBSR/MBRP)
  • opioid withdrawal evidenced by score ≥13 on the Clinical Opiate Withdrawal Scale
  • current cancer diagnosis
  • having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Wahlen VA Hospital

Salt Lake City, Utah, 84112, United States

Location

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 Officials

  • Eric Garland, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 17, 2016

Study Start

April 1, 2017

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

US(1)