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

Not Applicable

Terminated

• Conditions: Chronic, Non-neuropathic Back Pain
• Interventions: Behavioral: Support Group; Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

• Registration Number: NCT02935465
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Support Group	Support Group	Participants will attend a support group weekly for eight weeks.
Mindfulness-Oriented Recovery Enhancement	Mindfulness-Oriented Recovery Enhancement (MORE)	Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.

Primary Outcome Measures

Name	Time	Method
Changes in fMRI activity level during natural reward processing	Change from week 0 to 8 weeks	Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan.
Changes in endogenous opioid system function in response to pain challenge	Change from week 0 to 8 weeks	PET opioid receptor binding potential from baseline through pain challenge

Secondary Outcome Measures

Name	Time	Method
Pain sensitivity as a measure of volume of hypertonic saline	Change from week 0 to 8 weeks	Volume of hypertonic saline to maintain pain at 40 out of 100 on a VAS
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

Trial Locations

Locations (1)

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