Skip to main content
OpenTrials
Completed

NCT Number: NCT02935621

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Wahlen VA Hospital

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 group

Behavioral

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

Primary outcomes

  1. Change in opioid misuse

    Time frame: 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

  2. Change in pain severity and interference

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

    Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment)

Secondary outcomes

  1. Change in opioid craving

    Time frame: Baseline, during treatment

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

  2. Change in psychological distress

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

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

  3. Change in opioid dose (in morphine equivalents)

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

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

  4. Change in post-traumatic stress

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

    Change in Post-Traumatic Stress Checklist-Military from baseline through study completion (6 months post-treatment)

  5. Change in resilience

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

    Change in Response to Stressful Events Scale from baseline through study completion (6 months post-treatment)

Other outcomes

  1. Change in nonreactivity

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

    Change in Five Facet Mindfulness Questionnaire nonreactivity subscale from baseline through study completion (6 months post-treatment)

  2. Change in reinterpretation of pain sensations

    Time frame: 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)

  3. Change in emotion regulation

    Time frame: Baseline, post-treatment (8 weeks from beginning of treatment)

    Change from baseline through post-treatment as measured by responses on the Emotion Regulation Task.

  4. Change in positive emotion

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

    Change in Positive and Negative Affect Scale from baseline through study completion (6 months post-treatment)

  5. Change in cue-reactivity

    Time frame: 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

  6. Change in attention to positive information

    Time frame: 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)

  7. Change in interoceptive awareness

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

    Change in Multidimensional Assessment of Interoceptive Awareness from baseline through study completion (6 months post-treatment)

  8. Change in EEG spectral power during mindfulness

    Time frame: 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.

  9. Change in anhedonia

    Time frame: Baseline, and through 6 months follow-up

    Change in Snaith Hamilton Anhedonia and Pleasure Scale from baseline through 6 month follow-up

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2016
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.