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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935621
• Other study ID #: 00091781
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	George Wahlen VA Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in nonreactivity	Change in Five Facet Mindfulness Questionnaire nonreactivity subscale from baseline through study completion (6 months post-treatment)	Baseline, and through 6 months post-treatment
Other	Change in reinterpretation of pain sensations	Change in Coping Strategies Questionnaire reinterpretation of pain subscale from baseline through study completion (6 months post-treatment)	Baseline, and through 6 months post-treatment
Other	Change in emotion regulation	Change from baseline through post-treatment as measured by responses on the Emotion Regulation Task.	Baseline, post-treatment (8 weeks from beginning of treatment)
Other	Change in positive emotion	Change in Positive and Negative Affect Scale from baseline through study completion (6 months post-treatment)	Baseline, and through 6 months post-treatment
Other	Change in cue-reactivity	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	Baseline, post-treatment (8 weeks from beginning of treatment)
Other	Change in attention to positive information	Change in Attention to Positive and Negative Information Scale from baseline through study completion (6 months post-treatment)	Baseline, and through 6 months post-treatment
Other	Change in interoceptive awareness	Change in Multidimensional Assessment of Interoceptive Awareness from baseline through study completion (6 months post-treatment)	Baseline, and through 6 months post-treatment
Other	Change in EEG spectral power during mindfulness	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.	Baseline, post-treatment (8 weeks from beginning of treatment)
Other	Change in anhedonia	Change in Snaith Hamilton Anhedonia and Pleasure Scale from baseline through 6 month follow-up	Baseline, and through 6 months follow-up
Primary	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
Primary	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	Change in opioid craving	Change in EMA opioid craving measure from Wasan et. al 2012 from baseline through study treatment completion	Baseline, during treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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