Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation

NCT ID: NCT02935465

Last Updated: 2020-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-06-30

Brief Summary

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The overarching aim of this project is to conduct a randomized controlled study to determine whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.

Detailed Description

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Conditions

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Chronic, Non-neuropathic Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness-Oriented Recovery Enhancement

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

Group Type EXPERIMENTAL

Mindfulness-Oriented Recovery Enhancement (MORE)

Intervention Type 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.

Support Group

Participants will attend a support group weekly for eight weeks.

Group Type ACTIVE_COMPARATOR

Support Group

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-Oriented Recovery Enhancement (MORE)

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.

Intervention Type BEHAVIORAL

Support Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. age 21-60 years of age
2. English fluency
3. 20/20 vision with corrective lenses
4. current chronic, non-neuropathic back pain diagnosis determined by physician assessment
5. reporting pain ≥3 on 0-10 scale with opioid medication
6. current use of prescription opioids for ≥3 consecutive months
7. ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria

1. Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation)
2. psychosis
3. untreated, active suicidality in the past month
4. and severe non-opioid substance use disorder in the past year as assessed with the MINI
5. clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain
6. pregnancy
7. inability or unwillingness of individual to give written informed consent
8. physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Eric Garland

Associate Director of Integrative Medicine in Supportive Oncology and Survivorship, Huntsman Cancer Institute; Associate Dean for Research and Associate Professor, College of Social Work

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric L Garland, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Utah

Locations

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College of Social Work

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00093561

Identifier Type: -

Identifier Source: org_study_id

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