Clinical trial NCT02935621: Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain
Official title: Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain Conditions and Opioid Related Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-10-17
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in opioid misuse
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in pain severity and interference
timeFrame: Baseline, and through 6 months post-treatment
Secondary outcomes:
measure: Change in opioid craving
timeFrame: Baseline, during treatment
measure: Change in psychological distress
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in opioid dose (in morphine equivalents)
timeFrame: Baseline, during treatment, and through 6 months post-treatment
measure: Change in post-traumatic stress
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in resilience
timeFrame: Baseline, and through 6 months post-treatment
Other outcomes:
measure: Change in nonreactivity
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in reinterpretation of pain sensations
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in emotion regulation
timeFrame: Baseline, post-treatment (8 weeks from beginning of treatment)
measure: Change in positive emotion
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in cue-reactivity
timeFrame: Baseline, post-treatment (8 weeks from beginning of treatment)
measure: Change in attention to positive information
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in interoceptive awareness
timeFrame: Baseline, and through 6 months post-treatment
measure: Change in EEG spectral power during mindfulness
timeFrame: Baseline, post-treatment (8 weeks from beginning of treatment)
measure: Change in anhedonia
timeFrame: Baseline, and through 6 months follow-up
Locations:
city: Salt Lake City
country: United States
facility: George Wahlen VA Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Eric Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References: