Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mindfulness-Oriented Recovery Enhancement Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. |
Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
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.
|
| Active Comparator: Support Group Participants will attend a support group weekly for eight weeks. |
Behavioral: Support Group
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
|
Outcome Measures
Primary Outcome Measures
- Change in opioid misuse [Baseline, and through 6 months post-treatment]
Change 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
- 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)
Secondary Outcome Measures
- Change in opioid craving [Baseline, during treatment, and through 6 months post-treatment]
Change in opioid craving measure from Wasan et. al 2012 from baseline through study completion (6 months post-treatment)
- 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)
- 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 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)
Other Outcome Measures
- Change in nonreactivity [Baseline, and through 6 months post-treatment]
Change in Five Facet Mindfulness Questionnaire nonreactivity subscale from baseline through study completion (6 months post-treatment)
- Change in reinterpretation of pain sensations [Baseline, and through 6 months post-treatment]
Change in Coping Strategies Questionnaire reinterpretation of pain subscale from baseline through study completion (6 months post-treatment)
- Change in emotion regulation [Baseline, post-treatment (8 weeks from beginning of treatment)]
Change from baseline through post-treatment as measured by responses on the Emotion Regulation Task.
- Change in positive emotion [Baseline, and through 6 months post-treatment]
Change in Positive and Negative Affect Scale from baseline through study completion (6 months post-treatment)
- Change in cue-reactivity [Baseline, post-treatment (8 weeks from beginning of treatment)]
Change from baseline through post-treatment as evidenced by attentional bias and autonomic responses during lab-based task involving rapid presentation of cues designed to measure cue-reactivity
- Change in attention to positive information [Baseline, and through 6 months post-treatment]
Change in Attention to Positive and Negative Information Scale from baseline through study completion (6 months post-treatment)
- Change in interoceptive awareness [Baseline, and through 6 months post-treatment]
Change in Multidimensional Assessment of Interoceptive Awareness from baseline through study completion (6 months post-treatment)
- Change in EEG spectral power during mindfulness [Baseline, post-treatment (8 weeks from beginning of treatment)]
In an ancillary mechanistic sub-study, a subset of participants will be assessed with EEG during a laboratory-based mindfulness meditation practice session. EEG frequency analyses will compute spectral power bands during mindfulness.
- Change in anhedonia [Baseline, and through 6 months follow-up]
Change in Snaith Hamilton Anhedonia and Pleasure Scale from baseline through 6 month follow-up
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | George Wahlen VA Hospital | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Utah
- United States Department of Defense
Investigators
- Principal Investigator: Eric Garland, PhD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00091781