Chronic PainNCT03298269
Behavioral Interventions for Chronic Pain and Opioid-Related Problems
A study testing Mindfulness-Oriented Recovery Enhancement and Supportive Counseling in people with Chronic Pain, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain. 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 and Supportive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 1 Oct 2020
- 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
- Age 18-60+
- Current chronic pain condition
- Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days
Who cannot join
- Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
- Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)
- Opioid misuse as determined by Current Opioid Misuse Measure
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.
- Conditions
- Chronic Pain
- Being tested
- Mindfulness-Oriented Recovery Enhancement, Supportive Counseling
- 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 EnhancementBehavioural
Also called MORE
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.
Supportive CounselingBehavioural
Also called Support Group
A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental | Not described Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement |
| Supportive Counseling | Active comparator | Not described Receives: Behavioral: Supportive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain symptoms
Pain severity and interference as measured by the Brief Pain Inventory
Measured: Change from baseline through study completion (9 months post-treatment)
Change in aberrant drug-related behaviors
Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen
Measured: Change from baseline through study completion (9 months post-treatment)
Secondary outcomes (8)
Change in emotional distress
Distress measured by the Depression, Anxiety, Stress Scale
Measured: Change from baseline through study completion (9 months post-treatment)
Change in opioid dose
Opioid dose converted into morphine equivalents via standardized equianalgesic tables
Measured: Change from baseline through study completion (9 months post-treatment)
Change in opioid craving
Craving measured by visual analogue scale
Measured: Change from baseline through study completion (9 months post-treatment)
Change in interoceptive awareness
Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness
Measured: Change from baseline through 8 weeks
Change in reappraisal
Reappraisal measured by the Emotion Regulation Questionnaire
Measured: Change from baseline through 8 weeks
Change in savoring
Savoring measured by the brief Ways of Savoring checklist
Measured: Change from baseline through 8 weeks
Change in meditative experiences
As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment
Measured: Change from baseline through 8 weeks
Change in body sensations
Change in pleasant, neutral, and unpleasant body sensations as measured by body map
Measured: Change from baseline through 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start26 Sep 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Garland, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298269
- Sponsor's protocol ID
- 1618
- Status last verified
- Dec 2021
- First submitted
- 26 Sep 2017
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garland EL, Hudak J, Hanley AW, Nakamura Y. Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. Am Psychol. 2020 Sep;75(6):840-852. doi: 10.1037/amp0000638.
PubMed 32915027Garland EL, Hanley AW, Riquino MR, Reese SE, Baker AK, Salas K, Yack BP, Bedford CE, Bryan MA, Atchley R, Nakamura Y, Froeliger B, Howard MO. Mindfulness-oriented recovery enhancement reduces opioid misuse risk via analgesic and positive psychological mechanisms: A randomized controlled trial. J Consult Clin Psychol. 2019 Oct;87(10):927-940. doi: 10.1037/ccp0000390.
PubMed 31556669
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions for Chronic Pain and Opioid-Related Problems
- ClinicalTrials.gov ID
- NCT03298269
- Acronym / sponsor ID
- 1618
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 2 Oct 2017 (actual)
- 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 purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement | Experimental | Behavioral: Mindfulness-Oriented Recovery Enhancement |
| Supportive Counseling | Active comparator | Behavioral: Supportive Counseling |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-60+
- Current chronic pain condition
- Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days
Key exclusion criteria (3 listed)
- Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
- Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)
- Opioid misuse as determined by Current Opioid Misuse Measure
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 EnhancementAlso: MOREMindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills. | Behavioural | Mindfulness-Oriented Recovery Enhancement |
| Supportive CounselingAlso: Support GroupA support group led by a therapist will allow participants to express emotions, share experiences, and receive social support. | Behavioural | Supportive Counseling |
Primary outcome
Change in pain symptoms
Time frame: Change from baseline through study completion (9 months post-treatment)
Pain severity and interference as measured by the Brief Pain Inventory
Change in aberrant drug-related behaviors
Time frame: Change from baseline through study completion (9 months post-treatment)
Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen
8 secondary outcomes
Change in emotional distress
Time frame: Change from baseline through study completion (9 months post-treatment)
Change in opioid dose
Time frame: Change from baseline through study completion (9 months post-treatment)
Change in opioid craving
Time frame: Change from baseline through study completion (9 months post-treatment)
Change in interoceptive awareness
Time frame: Change from baseline through 8 weeks
Change in reappraisal
Time frame: Change from baseline through 8 weeks
Change in savoring
Time frame: Change from baseline through 8 weeks
Change in meditative experiences
Time frame: Change from baseline through 8 weeks
Change in body sensations
Time frame: Change from baseline through 8 weeks
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 10 Dec 2021.
- Derived from this study: PubMed 32915027Garland EL, Hudak J, Hanley AW, Nakamura Y. Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. Am Psychol. 2020 Sep;75(6):840-852. doi: 10.1037/amp0000638.
- Derived from this study: PubMed 31556669Garland EL, Hanley AW, Riquino MR, Reese SE, Baker AK, Salas K, Yack BP, Bedford CE, Bryan MA, Atchley R, Nakamura Y, Froeliger B, Howard MO. Mindfulness-oriented recovery enhancement reduces opioid misuse risk via analgesic and positive psychological mechanisms: A randomized controlled trial. J Consult Clin Psychol. 2019 Oct;87(10):927-940. doi: 10.1037/ccp0000390.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Supportive Counseling 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 3 inclusion and 3 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 10 Dec 2021. 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 pain symptoms (time frame: Change from baseline through study completion (9 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?
On the ClinicalTrials.gov record for NCT03298269, which also lists 2 linked publications.
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 10 Dec 2021.