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

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Chronic, Non-neuropathic Back Pain

Treatments: Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE); Behavioral: Support Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02935465

00093561

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Mindfulness-Oriented Recovery Enhancement

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

Support Group

Active Comparator group

Description:

Participants will attend a support group weekly for eight weeks.

Treatment:

Behavioral: Support Group