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| ID | Type | Description | Link |
|---|---|---|---|
| R03DA032517 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Fahs Beck Fund for Research and Experimentation | UNKNOWN |
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Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.
Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental |
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| Conventional Support Group (SG) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Behavioral | MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity, pain functional interference | Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form. | Baseline, immediately following treatment, and at 3 month follow-up |
| Opioid craving | Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving. | Baseline, immediately following treatment, and at 3 month follow-up |
| Opioid misuse behaviors | Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure | Baseline, immediately following treatment, and at 3 month follow-up |
| Well-being | Change in well-being as measured by the WHO-5 | Baseline, immediately following treatment, and at 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Attentional bias | Change in attentional bias as measured by a dot probe task | Baseline and immediately following treatment |
| Psychophysiological cue-reactivity | Change in psychophysiological cue-reactivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric L Garland, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSU College of Social Work | Tallahassee | Florida | 32306-2570 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional Support Group (SG) | Behavioral | The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions. |
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| Baseline and immediately following treatment |
| Emotional response inhibition | Change in emotional response inhibition | Baseline and immediately following treatment |
| Pain coping strategies | Change in reinterpretation of pain sensations, catastrophizing, and suppression. | Baseline, intervention midpoint, and immediately following treatment |
| Anhedonia | Change in anhedonia | Baseline and immediately following treatment |
| Fear of pain | Change in fear of pain | Baseline and immediately following treatment |
| Mindfulness | Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale | Baseline, intervention midpoint, and immediately following treatment |
| Positive reappraisal | Change in positive reappraisal | Baseline and immediately following treatment |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |