Chronic PainNCT05194241
One MORE for Chronic Pain
A study testing One MORE 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 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 27 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men/women ≥18 years of age
- current chronic pain diagnosis
- reporting pain ≥3 on 0-10 scale
Who cannot join
- unstable illness judged by clinician to interfere with study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Efficacy of a Single Session Mindfulness Oriented Recovery Enhancement Intervention: One MORE
This study will be a single-site, two-arm randomized controlled trial conducted among 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 via a HIPAA compliant virtual meeting platform.
- Conditions
- Chronic Pain
- Being tested
- One MORE
- 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 MOREBehavioural
One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute 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. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring.
| Study group | Role | What they receive |
|---|---|---|
| One MORE | Experimental | Not described Receives: Behavioral: One MORE |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing
Change in pain catastrophizing from baseline through 3-month follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing.
Measured: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Secondary outcomes (2)
Pain Intensity
Change in pain intensity from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity.
Measured: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Pain Interference
Change in pain interference from baseline through 3-month follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 20, with higher scores reflecting greater pain interference.
Measured: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start18 Nov 2021
- Primary completion27 Nov 2022
- Study completion27 Nov 2022
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194241
- Sponsor's protocol ID
- 00146987
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hanley AW, Lingard A, Garland EL. A Single-Session, 2-Hour Version of Mindfulness-Oriented Recovery Enhancement (One MORE) Improves Chronic Pain Patients' Pain-Related Outcomes Through 3-Month Follow-Up in a Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):869-877. doi: 10.1089/jicm.2023.0501. Epub 2024 Apr 8.
PubMed 38588552
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Single Session Mindfulness Oriented Recovery Enhancement Intervention: One MORE
- ClinicalTrials.gov ID
- NCT05194241
- Acronym / sponsor ID
- 00146987
- Conditions
- Chronic Pain
- Keywords
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Nov 2022 (actual)
- First posted
- 18 Jan 2022 (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 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 via a HIPAA compliant virtual meeting platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One MORE | Experimental | Behavioral: One MORE |
| 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 (3 listed)
- men/women ≥18 years of age
- current chronic pain diagnosis
- reporting pain ≥3 on 0-10 scale
Key exclusion criteria (1 listed)
- unstable illness judged by clinician to interfere with study participation
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 MOREOne MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute 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. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring. | Behavioural | One MORE |
Primary outcome
Pain Catastrophizing
Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Change in pain catastrophizing from baseline through 3-month follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing.
2 secondary outcomes
Pain Intensity
Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
Pain Interference
Time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.
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 15 Mar 2023.
- Derived from this study: PubMed 38588552Hanley AW, Lingard A, Garland EL. A Single-Session, 2-Hour Version of Mindfulness-Oriented Recovery Enhancement (One MORE) Improves Chronic Pain Patients' Pain-Related Outcomes Through 3-Month Follow-Up in a Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):869-877. doi: 10.1089/jicm.2023.0501. Epub 2024 Apr 8.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Not yet recruiting
Effects of Expectancy and Mindfulness Instructions on Chronic Pain
Chronic Pain
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Chronic Pain, Low Back Pain
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 One MORE 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 1 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 15 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?
Pain Catastrophizing (time frame: Will be completed at baseline, week 2, and 1, 2, and 3 months after baseline.). 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 NCT05194241, 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 15 Mar 2023.