Chronic Musculoskeletal PainBrief ReliefNCT07193095
This Project is a Three-arm RCT Evaluating Two, Single-session Behavioral Interventions for Adults With Chronic Musculoskeletal Pain (CMP) -- 1) Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) vs. Empowered Relief (ER) -- Relative to the Traditional 8-week Version of MORE.
A study testing Brief Mindfulness Oriented Recovery Enhancement, Empowered Relief and Mindfulness Oriented Recovery Enhancement in people with Chronic Musculoskeletal Pain, run by Florida State University at 1 site in United States.
Trial summary
Researchers at Florida State University are investigating how the length of treatment influences outcomes for individuals with chronic musculoskeletal pain. The goal is to identify the most effective balance between treatment duration and pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Brief Mindfulness Oriented Recovery Enhancement, Empowered Relief and Mindfulness Oriented Recovery Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- (1) having a chronic musculoskeletal pain condition, (2) average pain of ≥ 3 in the previous week, (3) willingness to engage with study assessments and interventions, (4) understanding English instructions fluently, and (5) being 18 and above.
Who cannot join
- (1) unable to consent because of physical or mental incapacity, (2) have previous, formal mindfulness training (e.g., MBSR) or previously receiving Empowered Relief, (3) have pain from a current cancer diagnosis or cancer-related treatment, (4) unstable illness that may interfere with treatment, (5) had surgery within the previous three months, and (6) had pain relieving injections, such as cortisone or hyaluronate, within the previous three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Research Building B
Tallahassee, Florida, 32310
About this study
Official title: Brief MORE: A Mindfulness Intervention For Chronic Musculoskeletal Pain
Researchers at Florida State University are investigating how the length of treatment influences outcomes for individuals with chronic musculoskeletal pain. The goal is to identify the most effective balance between treatment duration and pain relief. There are three treatment conditions in this study: two different brief pain management trainings and one standard-length training. Participants will be randomized to either of the brief trainings, attending a single, 2-hour, online training session, in which a trained facilitator will teach pain management techniques that are backed by research. If randomized to receive the standard-length training, participants will attend eight, 2-hour, online training session over eight weeks, in which a trained facilitator will also teach research-backed pain management techniques. Short surveys will be required at seven different time points: before starting treatment, immediately after the pain-management training, and then 2, 6, 12, 24, and 36 weeks after the training.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Brief Mindfulness Oriented Recovery Enhancement, Empowered Relief, Mindfulness Oriented Recovery Enhancement
- Keywords
- Chronic pain, Brief intervention, Remote
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Mindfulness Oriented Recovery EnhancementBehavioural
B-MORE is a 2-hour, single session adaptation of the traditional MORE program.
Empowered ReliefBehavioural
ER is an evidence-based 2-hour single session intervention for chronic pain.
Mindfulness Oriented Recovery EnhancementBehavioural
MORE is an 8-week evidence-based treatment for chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| Brief Mindfulness Oriented Recovery Enhancement (B-MORE) | Experimental | B-MORE is a 2-hour, single session adaptation of the traditional MORE program. Receives: Behavioral: Brief Mindfulness Oriented Recovery Enhancement |
| Empowered Relief (ER) | Experimental | ER is an evidence-based 2-hour single session intervention for chronic pain Receives: Behavioral: Empowered Relief |
| Mindfulness Oriented Recovery Enhancement (MORE) | Experimental | MORE is an 8-week evidence-based treatment for chronic pain. Receives: Behavioral: Mindfulness Oriented Recovery Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Recruitment feasibility will be assessed via total enrollment and randomization numbers within the first 6 months of the study. Study team projects that it will be feasible to recruit and randomize 30 adults with CMP within 6 months.
Measured: 6 months
Treatment Adherence & Acceptability
Adherence (percentage of total treatment time attended) will be better for the single-session interventions, but all three conditions will be rated as highly acceptable (as measured by the Theoretical Framework of Acceptability; TFA).
Measured: From baseline to 9-month follow-up
Secondary outcomes (2)
PROMIS - Pain Intensity
A 3-item questionnaire using a 5-point Likert-like scale (1- had no pain to 5- very severe). Questions include "In the past 7 days, How intense was your pain at its worst?"
Measured: From baseline to 9-month follow-up
PROMIS - Pain Interference
An 8-item questionnaire using a 5-point Likert-like scale (1- not at all to 5- very much). Questions include "In the past 7 days, how much did pain interfere with work around the home?".
Measured: From baseline to 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start14 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193095
- Sponsor's protocol ID
- 00006036
- Acronym
- Brief Relief
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon request from qualified individuals.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief MORE: A Mindfulness Intervention For Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT07193095
- Acronym / sponsor ID
- Brief Relief / 00006036
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- Chronic pain, Brief intervention, Remote
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
Researchers at Florida State University are investigating how the length of treatment influences outcomes for individuals with chronic musculoskeletal pain. The goal is to identify the most effective balance between treatment duration and pain relief. There are three treatment conditions in this study: two different brief pain management trainings and one standard-length training. Participants will be randomized to either of the brief trainings, attending a single, 2-hour, online training session, in which a trained facilitator will teach pain management techniques that are backed by research. If randomized to receive the standard-length training, participants will attend eight, 2-hour, online training session over eight weeks, in which a trained facilitator will also teach research-backed pain management techniques. Short surveys will be required at seven different time points: before starting treatment, immediately after the pain-management training, and then 2, 6, 12, 24, and 36 weeks after the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Mindfulness Oriented Recovery Enhancement (B-MORE) | Experimental | Behavioral: Brief Mindfulness Oriented Recovery EnhancementB-MORE is a 2-hour, single session adaptation of the traditional MORE program. |
| Empowered Relief (ER) | Experimental | Behavioral: Empowered ReliefER is an evidence-based 2-hour single session intervention for chronic pain |
| Mindfulness Oriented Recovery Enhancement (MORE) | Experimental | Behavioral: Mindfulness Oriented Recovery EnhancementMORE is an 8-week evidence-based treatment for chronic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) having a chronic musculoskeletal pain condition, (2) average pain of ≥ 3 in the previous week, (3) willingness to engage with study assessments and interventions, (4) understanding English instructions fluently, and (5) being 18 and above.
Key exclusion criteria (1 listed)
- (1) unable to consent because of physical or mental incapacity, (2) have previous, formal mindfulness training (e.g., MBSR) or previously receiving Empowered Relief, (3) have pain from a current cancer diagnosis or cancer-related treatment, (4) unstable illness that may interfere with treatment, (5) had surgery within the previous three months, and (6) had pain relieving injections, such as cortisone or hyaluronate, within the previous three months.
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 |
|---|---|---|
| Brief Mindfulness Oriented Recovery EnhancementB-MORE is a 2-hour, single session adaptation of the traditional MORE program. | Behavioural | Brief Mindfulness Oriented Recovery Enhancement (B-MORE) |
| Empowered ReliefER is an evidence-based 2-hour single session intervention for chronic pain. | Behavioural | Empowered Relief (ER) |
| Mindfulness Oriented Recovery EnhancementMORE is an 8-week evidence-based treatment for chronic pain. | Behavioural | Mindfulness Oriented Recovery Enhancement (MORE) |
Primary outcome
Recruitment Feasibility
Time frame: 6 months
Recruitment feasibility will be assessed via total enrollment and randomization numbers within the first 6 months of the study. Study team projects that it will be feasible to recruit and randomize 30 adults with CMP within 6 months.
Treatment Adherence & Acceptability
Time frame: From baseline to 9-month follow-up
Adherence (percentage of total treatment time attended) will be better for the single-session interventions, but all three conditions will be rated as highly acceptable (as measured by the Theoretical Framework of Acceptability; TFA).
2 secondary outcomes
PROMIS - Pain Intensity
Time frame: From baseline to 9-month follow-up
PROMIS - Pain Interference
Time frame: From baseline to 9-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon request from qualified individuals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Mindfulness Oriented Recovery Enhancement, Empowered Relief and Mindfulness Oriented Recovery Enhancement in people with Chronic Musculoskeletal Pain, run by Florida State University 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 1 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Hanley, PhD (850-270-7844, adam.hanley@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: 6 months). 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 25 Sep 2025.