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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental | Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. |
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| Support Group | Active Comparator | Participants will attend a support group weekly for eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in opioid misuse | 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 | Baseline, and through 6 months post-treatment |
| Change in pain severity and interference | Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment) | Baseline, and through 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in opioid craving | Change in EMA opioid craving measure from Wasan et. al 2012 from baseline through study treatment completion | Baseline, during treatment |
| Change in psychological distress |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nonreactivity | Change in Five Facet Mindfulness Questionnaire nonreactivity subscale from baseline through study completion (6 months post-treatment) | Baseline, and through 6 months post-treatment |
| Change in reinterpretation of pain sensations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Garland, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Wahlen VA Hospital | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| 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. |
|
Change in Depression Anxiety Stress Scale from baseline through study completion (6 months post-treatment)
| Baseline, and through 6 months post-treatment |
| Change in opioid dose (in morphine equivalents) | Change from baseline through study completion (6 months post-treatment) | Baseline, during treatment, and through 6 months post-treatment |
| Change in post-traumatic stress | Change in Post-Traumatic Stress Checklist-Military from baseline through study completion (6 months post-treatment) | Baseline, and through 6 months post-treatment |
| Change in resilience | Change in Response to Stressful Events Scale from baseline through study completion (6 months post-treatment) | 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)
| Baseline, and through 6 months post-treatment |
| Change in emotion regulation | Change from baseline through post-treatment as measured by responses on the Emotion Regulation Task. | Baseline, post-treatment (8 weeks from beginning of treatment) |
| Change in positive emotion | Change in Positive and Negative Affect Scale from baseline through study completion (6 months post-treatment) | Baseline, and through 6 months post-treatment |
| Change in cue-reactivity | 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 | Baseline, post-treatment (8 weeks from beginning of treatment) |
| Change in attention to positive information | Change in Attention to Positive and Negative Information Scale from baseline through study completion (6 months post-treatment) | Baseline, and through 6 months post-treatment |
| Change in interoceptive awareness | Change in Multidimensional Assessment of Interoceptive Awareness from baseline through study completion (6 months post-treatment) | Baseline, and through 6 months post-treatment |
| Change in EEG spectral power during mindfulness | 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. | Baseline, post-treatment (8 weeks from beginning of treatment) |
| Change in anhedonia | Change in Snaith Hamilton Anhedonia and Pleasure Scale from baseline through 6 month follow-up | Baseline, and through 6 months follow-up |