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

NCT02935465 | Terminated DMC

• 1 other identifier: 00093561
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic, Non-neuropathic Back Pain

Outcome Measures

Primary Outcomes (2)

• Changes in endogenous opioid system function in response to pain challenge

  PET opioid receptor binding potential from baseline through pain challenge

  Change from week 0 to 8 weeks

• Changes in fMRI activity level during natural reward processing

  Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan.

  Change from week 0 to 8 weeks

Secondary Outcomes (3)

• Pain sensitivity as a measure of volume of hypertonic saline

  Change from week 0 to 8 weeks

• Self-report affect ratings

  Change from week 0 to 8 weeks

• Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use

  Change from week 0 to 8 weeks

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 Group BEHAVIORAL

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

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

College of Social Work

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Eric L Garland, PhD

  The University of Utah

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 17, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

US (1)