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

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT02935621
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Study Start: 2017-04-01
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-19
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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 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 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 psychological distress	Baseline, and through 6 months post-treatment	Change in Depression Anxiety Stress Scale from baseline through study completion (6 months post-treatment)

Trial Locations

Locations (1)

George Wahlen VA Hospital; 🇺🇸 Salt Lake City, Utah, United States