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

University of Utah230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

230

Conditions

Chronic Pain

Interventions

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.

Support GroupBEHAVIORAL

A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

George Wahlen VA Hospital

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: Baseline, and through 6 months post-treatment

Secondary Outcomes

Change in opioid craving

Change in EMA opioid craving measure from Wasan et. al 2012 from baseline through study treatment completion

Time frame: Baseline, during treatment

Change in psychological distress

Change in Depression Anxiety Stress Scale from baseline through study completion (6 months post-treatment)

Time frame: Baseline, and through 6 months post-treatment

Change in opioid dose (in morphine equivalents)

Change from baseline through study completion (6 months post-treatment)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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