- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02935621
Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain
March 19, 2023 updated by: Eric Garland, University of Utah
Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain Conditions and Opioid Related Problems
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amy Watson
- Phone Number: 801-581-6276
- Email: amy.watson@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- George Wahlen VA Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Support Group
Participants will attend a support group weekly for eight weeks.
|
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
|
Experimental: Mindfulness-Oriented Recovery Enhancement
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline, and through 6 months post-treatment
|
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
|
Baseline, and through 6 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline, and through 6 months post-treatment
|
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)
|
Baseline, during treatment, and through 6 months post-treatment
|
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)
|
Baseline, and through 6 months post-treatment
|
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)
|
Baseline, and through 6 months post-treatment
|
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
|
Baseline, during treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline, and through 6 months post-treatment
|
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)
|
Baseline, and through 6 months post-treatment
|
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.
|
Baseline, post-treatment (8 weeks from beginning of treatment)
|
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)
|
Baseline, and through 6 months post-treatment
|
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
|
Baseline, post-treatment (8 weeks from beginning of treatment)
|
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)
|
Baseline, and through 6 months post-treatment
|
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)
|
Baseline, and through 6 months post-treatment
|
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.
|
Baseline, post-treatment (8 weeks from beginning of treatment)
|
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
|
Baseline, and through 6 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 15, 2022
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
October 13, 2016
First Posted (Estimate)
October 17, 2016
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 19, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00091781
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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