Chronic PainNCT02935621
Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain
A study testing Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group in people with Chronic Pain, run by University of Utah at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Wahlen VA Hospital
Salt Lake City, Utah, 84112
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Mindfulness-Oriented Recovery Enhancement (MORE), Support Group
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Oriented Recovery Enhancement (MORE)Behavioural
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 GroupBehavioural
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental | Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) |
| Support Group | Active comparator | Participants will attend a support group weekly for eight weeks. Receives: Behavioral: Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, and through 6 months post-treatment
Change in pain severity and interference
Change on Brief Pain Inventory items from baseline through study completion (6 months post-treatment)
Measured: Baseline, and through 6 months post-treatment
Secondary outcomes (5)
Change in opioid craving
Change in EMA opioid craving measure from Wasan et. al 2012 from baseline through study treatment completion
Measured: Baseline, during treatment
Change in psychological distress
Change in Depression Anxiety Stress Scale from baseline through study completion (6 months post-treatment)
Measured: Baseline, and through 6 months post-treatment
Change in opioid dose (in morphine equivalents)
Change from baseline through study completion (6 months post-treatment)
Measured: Baseline, during treatment, and through 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)
Measured: Baseline, and through 6 months post-treatment
Change in resilience
Change in Response to Stressful Events Scale from baseline through study completion (6 months post-treatment)
Measured: Baseline, and through 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start1 Apr 2017
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Eric Garland, University of Utah
- Investigators
- Eric Garland, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935621
- Sponsor's protocol ID
- 00091781
- Status last verified
- Mar 2023
- First submitted
- 11 Oct 2016
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain Conditions and Opioid Related Problems
- ClinicalTrials.gov ID
- NCT02935621
- Acronym / sponsor ID
- 00091781
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental | Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. |
| Support Group | Active comparator | Behavioral: Support GroupParticipants will attend a support group weekly for eight weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-Oriented Recovery Enhancement |
| Support GroupA conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist. | Behavioural | Support Group |
Primary outcome
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
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)
5 secondary outcomes
Change in opioid craving
Time frame: Baseline, during treatment
Change in psychological distress
Time frame: 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 in post-traumatic stress
Time frame: Baseline, and through 6 months post-treatment
Change in resilience
Time frame: Baseline, and through 6 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Garland, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group in people with Chronic Pain, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in opioid misuse (time frame: Baseline, and through 6 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.