Chronic Pain
Conditions
Brief summary
The central aim of this proposed study is to test a multimodal, mindfulness-oriented intervention designed to disrupt the risk chain leading to prescription opioid dose escalation, opioid misuse and opioid addiction, which are mounting threats to active duty service members and Veterans with chronic pain conditions, who may develop disordered opioid use as a consequence of long-term opioid pharmacotherapy.
Interventions
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.
BEHAVIORALSupport Group
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Sponsors
United States Department of Defense
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* men/women ≥18 years of age * ability to understand and speak the English language * current chronic pain diagnosis (including but not limited to ICD-9 diagnoses 338.0, 338.2xx, 338. * current use of prescription opioids for \>3 consecutive months.
Exclusion criteria
* Mindfulness training experience (participation in MBSR/MBRP) * opioid withdrawal evidenced by score ≥13 on the Clinical Opiate Withdrawal Scale * current cancer diagnosis * having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid misuse | Baseline, and through 6 months post-treatment | Change in Current Opioid Misuse Measure from baseline through study completion (6 months post-treatment). Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen |
| Change in pain severity and interference | Baseline, and through 6 months post-treatment | Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid dose (in morphine equivalents) | Baseline, during treatment, and through 6 months post-treatment | Change from baseline through study completion (6 months post-treatment) |
| Change in opioid craving | Baseline, during treatment | Change in EMA opioid craving measure from Wasan et. al 2012 from baseline through study treatment completion |
| Change in resilience | Baseline, and through 6 months post-treatment | Change in Response to Stressful Events Scale from baseline through study completion (6 months post-treatment) |
| Change in post-traumatic stress | Baseline, and through 6 months post-treatment | Change in Post-Traumatic Stress Checklist-Military from baseline through study completion (6 months post-treatment) |
| Change in psychological distress | Baseline, and through 6 months post-treatment | Change in Depression Anxiety Stress Scale from baseline through study completion (6 months post-treatment) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in EEG spectral power during mindfulness | Baseline, post-treatment (8 weeks from beginning of treatment) | In an ancillary mechanistic sub-study, a subset of participants will be assessed with EEG during a laboratory-based mindfulness meditation practice session. EEG frequency analyses will compute spectral power bands during mindfulness. |
| Change in nonreactivity | Baseline, and through 6 months post-treatment | Change in Five Facet Mindfulness Questionnaire nonreactivity subscale from baseline through study completion (6 months post-treatment) |
| Change in anhedonia | Baseline, and through 6 months follow-up | Change in Snaith Hamilton Anhedonia and Pleasure Scale from baseline through 6 month follow-up |
| Change in reinterpretation of pain sensations | Baseline, and through 6 months post-treatment | Change in Coping Strategies Questionnaire reinterpretation of pain subscale from baseline through study completion (6 months post-treatment) |
| Change in emotion regulation | Baseline, post-treatment (8 weeks from beginning of treatment) | Change from baseline through post-treatment as measured by responses on the Emotion Regulation Task. |
| Change in positive emotion | Baseline, and through 6 months post-treatment | Change in Positive and Negative Affect Scale from baseline through study completion (6 months post-treatment) |
| Change in cue-reactivity | Baseline, post-treatment (8 weeks from beginning of treatment) | Change from baseline through post-treatment as evidenced by attentional bias and autonomic responses during lab-based task involving rapid presentation of cues designed to measure cue-reactivity |
| Change in attention to positive information | Baseline, and through 6 months post-treatment | Change in Attention to Positive and Negative Information Scale from baseline through study completion (6 months post-treatment) |
| Change in interoceptive awareness | Baseline, and through 6 months post-treatment | Change in Multidimensional Assessment of Interoceptive Awareness from baseline through study completion (6 months post-treatment) |
Countries
United States
Outcome results
None listed