Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain Conditions and Opioid Related Problems

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
* Behavioral: Support Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Oriented Recovery Enhancement<br>Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. | Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)<br>* 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.<br>|
| Active Comparator: Support Group<br>Participants will attend a support group weekly for eight weeks. | Behavioral: Support Group<br>* A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |