Chronic Pain
Conditions
Brief summary
The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.
Interventions
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.
BEHAVIORALSupportive Counseling
A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60+ * Current chronic pain condition * Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \>90 days
Exclusion criteria
* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention * Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence) * Opioid misuse as determined by Current Opioid Misuse Measure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain symptoms | Change from baseline through study completion (9 months post-treatment) | Pain severity and interference as measured by the Brief Pain Inventory |
| Change in aberrant drug-related behaviors | Change from baseline through study completion (9 months post-treatment) | Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid dose | Change from baseline through study completion (9 months post-treatment) | Opioid dose converted into morphine equivalents via standardized equianalgesic tables |
| Change in opioid craving | Change from baseline through study completion (9 months post-treatment) | Craving measured by visual analogue scale |
| Change in interoceptive awareness | Change from baseline through 8 weeks | Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness |
| Change in savoring | Change from baseline through 8 weeks | Savoring measured by the brief Ways of Savoring checklist |
| Change in meditative experiences | Change from baseline through 8 weeks | As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment |
| Change in body sensations | Change from baseline through 8 weeks | Change in pleasant, neutral, and unpleasant body sensations as measured by body map |
| Change in reappraisal | Change from baseline through 8 weeks | Reappraisal measured by the Emotion Regulation Questionnaire |
| Change in emotional distress | Change from baseline through study completion (9 months post-treatment) | Distress measured by the Depression, Anxiety, Stress Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in cue-reactivity | Change from baseline through 8 weeks | Change in EEG responses during a cue-reactivity task |
| Change in emotion regulation | Change from baseline through 8 weeks | Change in EEG responses during an emotion regulation task |
Countries
United States
Outcome results
None listed