Back to resultsBehavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Oriented Recovery Enhancement (MORE)
Support Group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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
Sites / Locations
- George Wahlen VA Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-Oriented Recovery Enhancement
Support Group
Arm Description
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Participants will attend a support group weekly for eight weeks.
Outcomes
Primary Outcome Measures
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
Change in pain severity and interference
Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment)
Secondary Outcome Measures
Change in opioid craving
Change in EMA opioid craving measure from Wasan et. al 2012 from baseline through study treatment completion
Change in psychological distress
Change in Depression Anxiety Stress Scale from baseline through study completion (6 months post-treatment)
Change in opioid dose (in morphine equivalents)
Change from baseline through study completion (6 months post-treatment)
Change in post-traumatic stress
Change in Post-Traumatic Stress Checklist-Military from baseline through study completion (6 months post-treatment)
Change in resilience
Change in Response to Stressful Events Scale from baseline through study completion (6 months post-treatment)
Full Information
NCT ID
NCT02935621
First Posted
October 11, 2016
Last Updated
March 19, 2023
Sponsor
University of Utah
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT02935621
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Oriented Recovery Enhancement
Arm Type
Experimental
Arm Description
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Arm Title
Support Group
Arm Type
Active Comparator
Arm Description
Participants will attend a support group weekly for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Oriented Recovery Enhancement (MORE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Support Group
Intervention Description
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Primary Outcome Measure Information:
Title
Change in opioid misuse
Description
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
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in pain severity and interference
Description
Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Secondary Outcome Measure Information:
Title
Change in opioid craving
Description
Change in EMA opioid craving measure from Wasan et. al 2012 from baseline through study treatment completion
Time Frame
Baseline, during treatment
Title
Change in psychological distress
Description
Change in Depression Anxiety Stress Scale from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in opioid dose (in morphine equivalents)
Description
Change from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, during treatment, and through 6 months post-treatment
Title
Change in post-traumatic stress
Description
Change in Post-Traumatic Stress Checklist-Military from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in resilience
Description
Change in Response to Stressful Events Scale from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Other Pre-specified Outcome Measures:
Title
Change in nonreactivity
Description
Change in Five Facet Mindfulness Questionnaire nonreactivity subscale from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in reinterpretation of pain sensations
Description
Change in Coping Strategies Questionnaire reinterpretation of pain subscale from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in emotion regulation
Description
Change from baseline through post-treatment as measured by responses on the Emotion Regulation Task.
Time Frame
Baseline, post-treatment (8 weeks from beginning of treatment)
Title
Change in positive emotion
Description
Change in Positive and Negative Affect Scale from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in cue-reactivity
Description
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
Time Frame
Baseline, post-treatment (8 weeks from beginning of treatment)
Title
Change in attention to positive information
Description
Change in Attention to Positive and Negative Information Scale from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in interoceptive awareness
Description
Change in Multidimensional Assessment of Interoceptive Awareness from baseline through study completion (6 months post-treatment)
Time Frame
Baseline, and through 6 months post-treatment
Title
Change in EEG spectral power during mindfulness
Description
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.
Time Frame
Baseline, post-treatment (8 weeks from beginning of treatment)
Title
Change in anhedonia
Description
Change in Snaith Hamilton Anhedonia and Pleasure Scale from baseline through 6 month follow-up
Time Frame
Baseline, and through 6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Garland, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Wahlen VA Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain
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