Chronic PainNCT06316713
One MORE for Chronic Pain in Latinos
A study testing One MORE (Spanish Adaptation) in people with Chronic Pain, run by University of Utah at 1 site in United States.
Trial summary
This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- One MORE (Spanish Adaptation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spanish-speaking
- Age 18+
- Diagnosed with a chronic pain condition
- Average pain in the previous week > or = 3
- Willingness to participate in study interventions and assessments.
Who cannot join
- Non Spanish-speaking
- Score of 10 or greater ('high risk') on the suicidality subsection of the MINI
- Psychotic episode within the last 12 months as deemed by the corresponding subsection of the MINI
- Presence of clinically unstable illness judged to interfere with treatment or study procedures
- Unable or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
- Communication or cognitive impairment that limits participation in treatment or study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Eric Garland, PhD, 801-581-3826, eric.garland@socwk.utah.edu
About this study
Official title: Spanish Language Adaptation of One MORE for Chronic Pain in Latinos
This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform.
- Conditions
- Chronic Pain
- Being tested
- One MORE (Spanish Adaptation)
- Keywords
- Mindfulness
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One MORE (Spanish Adaptation)Behavioural
One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into two, 1-hour segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Participants will also be guided through a mindful pain management practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The second segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, as well as learning to focus on increasing the positive emotions that can attenuate pain with mindful savoring.
| Study group | Role | What they receive |
|---|---|---|
| One MORE (Spanish Adaptation) | Experimental | Not described Receives: Behavioral: One MORE (Spanish Adaptation) |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity & Interference
Change in pain intensity and interference from baseline through 6-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 30, with higher scores reflecting greater pain intensity/interference.
Measured: Will be completed at baseline, week 2, and week 6.
Secondary outcomes (2)
Acute Pain
Change in acute pain will be measured with two individual items ("How much pain are you in, right now?", and "How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain.
Measured: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
Acceptability
Acceptability will be measured with two individual items ("How acceptable did you find the strategies for managing your pain?") and ("How likely would you be to recommend this therapy to someone else dealing with chronic pain?") Scores range from 0 to 10, with higher scores indicating greater program acceptability.
Measured: Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start8 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
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
- NCT06316713
- Sponsor's protocol ID
- IRB_00166637
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Minnick C, Hanley AW, Garland EL. Evaluation of a Spanish-language Adaptation of Brief Mindfulness-Oriented Recovery Enhancement for Chronic Pain: A Pilot Randomized Controlled Trial. Int J Behav Med. 2026 Jun 12. doi: 10.1007/s12529-026-10464-4. Online ahead of print.
PubMed 42284007
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Language Adaptation of One MORE for Chronic Pain in Latinos
- ClinicalTrials.gov ID
- NCT06316713
- Acronym / sponsor ID
- IRB_00166637
- Conditions
- Chronic Pain
- Keywords
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Mar 2024 (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.
This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One MORE (Spanish Adaptation) | Experimental | Behavioral: One MORE (Spanish Adaptation) |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spanish-speaking
- Age 18+
- Diagnosed with a chronic pain condition
- Average pain in the previous week > or = 3
- Willingness to participate in study interventions and assessments.
Key exclusion criteria (6 listed)
- Non Spanish-speaking
- Score of 10 or greater ('high risk') on the suicidality subsection of the MINI
- Psychotic episode within the last 12 months as deemed by the corresponding subsection of the MINI
- Presence of clinically unstable illness judged to interfere with treatment or study procedures
- Unable or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
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 |
|---|---|---|
| One MORE (Spanish Adaptation)One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into two, 1-hour segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Participants will also be guided through a mindful pain management practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The second segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, as well as learning to focus on increasing the positive emotions that can attenuate pain with mindful savoring. | Behavioural | One MORE (Spanish Adaptation) |
Primary outcome
Pain Intensity & Interference
Time frame: Will be completed at baseline, week 2, and week 6.
Change in pain intensity and interference from baseline through 6-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 30, with higher scores reflecting greater pain intensity/interference.
2 secondary outcomes
Acute Pain
Time frame: Will be completed immediately before and after each of the two, 1-hour sessions of the One MORE intervention.
Acceptability
Time frame: Will be completed immediately after the second of the two, 1-hour sessions of the One MORE intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 42284007Minnick C, Hanley AW, Garland EL. Evaluation of a Spanish-language Adaptation of Brief Mindfulness-Oriented Recovery Enhancement for Chronic Pain: A Pilot Randomized Controlled Trial. Int J Behav Med. 2026 Jun 12. doi: 10.1007/s12529-026-10464-4. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One MORE (Spanish Adaptation) 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Garland, PhD (801-581-3826, eric.garland@socwk.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity & Interference (time frame: Will be completed at baseline, week 2, and week 6.). 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 NCT06316713, which also lists 1 linked publication.
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 17 Apr 2024.