Chronic PainB-MORE v B-CBTNCT07207174
Brief Mindfulness-Oriented Recovery Enhancement vs Brief Cognitive-Behavioral Therapy for Chronic Pain
A study testing Brief Mindfulness Oriented Recovery Enhancement and Brief Cognitive-Behavioral Therapy in people with Chronic Pain, run by Florida State University at 1 site in United States.
Trial summary
This randomized controlled trial aims to test both English and Spanish versions of two, benign behavioral interventions for adults with chronic pain -- 1) Brief Mindfulness-Oriented Recovery Enhancement (B-MORE), and 2) Brief Cognitive- Behavioral Therapy (B-CBT). 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?
- Brief Mindfulness Oriented Recovery Enhancement and Brief Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2025to 22 Sep 2027
- 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
- Having a chronic pain condition
- Average pain of > 3 in the last week
- Willingness to engage with study assessments and interventions
- Understanding English or Spanish instructions fluently
- Age 18 and above.
Who cannot join
- Unable to consent because of physical or mental incapacity
- Have previous, formal mindfulness or CBT training (e.g., MBSR)
- Have pain from a current cancer diagnosis
- Unstable illness that may interfere with treatment
- Had surgery within the previous three months
- 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
Adam Hanley, PhD, 850-270-7844, adam.hanley@fsu.edu
About this study
Official title: Dual-Language Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) vs Brief Cognitive-Behavioral Therapy (B-CBT) for Chronic Pain
This randomized controlled trial aims to test both English and Spanish versions of two, benign behavioral interventions for adults with chronic pain -- 1) Brief Mindfulness-Oriented Recovery Enhancement (B-MORE), and 2) Brief Cognitive- Behavioral Therapy (B-CBT).
- Conditions
- Chronic Pain
- Being tested
- Brief Mindfulness Oriented Recovery Enhancement, Brief Cognitive-Behavioral Therapy
- Keywords
- Chronic pain, Spanish-language intervention, Mindfulness, Cognitive-behavioral Therapy, Brief intervention
- 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 adaptation of the traditional MORE program.
Brief Cognitive-Behavioral TherapyBehavioural
B-CBT is a 2-hour adaptation of a traditional 8-week CBT for Chronic Pain manual.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Intervention #1 | Experimental | Brief Mindfulness Oriented Recovery Enhancement (B-MORE) Receives: Behavioral: Brief Mindfulness Oriented Recovery Enhancement |
| Brief Behavioral Intervention #2 | Experimental | Brief Cognitive-Behavioral Therapy (B-CBT) Receives: Behavioral: Brief Cognitive-Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feasibility
Feasibility will be assessed by intervention adherence rates (percentage of treatment sessions completed).
Measured: At the first treatment session [1 hour] and the final treatment session [1 hour]
Treatment Acceptability
Treatment acceptability will be assessed by an adaptation of the Theoretical Framework of Acceptability scale (TFA).
Measured: Upon completion of the final treatment session [1 hour]
Secondary outcomes (5)
Chronic Pain Symptoms
Chronic Pain Symptoms will be measured via the Pain, Enjoyment, and General Activity scale (PEG-3).
Measured: Baseline and 2, 6, and 12-week post-treatment follow-ups
Depressive Symptoms
Depressive Symptoms will be measured with the Patient Health Questionnaire (PHQ-2).
Measured: Baseline and 2, 6, and 12-week post-treatment follow-ups
Anxiety Symptoms
Anxiety Symptoms will be measured with the Generalized Anxiety Disorder questionnaire (GAD-2).
Measured: Baseline and 2, 6, and 12-week post-treatment follow-ups
Wellbeing
Wellbeing will be measured with the World Health Organization Wellbeing Index (WHO-5).
Measured: Baseline and 2, 6, and 12-week post-treatment follow-ups
Pain Catastrophizing
Pain Catastrophizing will be measured with a validated 4-item adaptation of the Pain Catastrophizing scale (PCS-4).
Measured: Baseline and 2, 6, and 12-week post-treatment follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start26 Sep 2025
- Primary completion22 Sep 2027 (estimated)
- Study completion22 Sep 2027 (estimated)
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 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
- 120 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
- NCT07207174
- Sponsor's protocol ID
- 00006512
- Acronym
- B-MORE v B-CBT
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, SAP, ICF, and de-identified IPD will be shared with qualified individuals upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Language Brief Mindfulness-Oriented Recovery Enhancement (B-MORE) vs Brief Cognitive-Behavioral Therapy (B-CBT) for Chronic Pain
- ClinicalTrials.gov ID
- NCT07207174
- Acronym / sponsor ID
- B-MORE v B-CBT / 00006512
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Spanish-language intervention, Mindfulness, Cognitive-behavioral Therapy, Brief intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 3 Oct 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.
This randomized controlled trial aims to test both English and Spanish versions of two, benign behavioral interventions for adults with chronic pain -- 1) Brief Mindfulness-Oriented Recovery Enhancement (B-MORE), and 2) Brief Cognitive- Behavioral Therapy (B-CBT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Intervention #1 | Experimental | Behavioral: Brief Mindfulness Oriented Recovery EnhancementBrief Mindfulness Oriented Recovery Enhancement (B-MORE) |
| Brief Behavioral Intervention #2 | Experimental | Behavioral: Brief Cognitive-Behavioral TherapyBrief Cognitive-Behavioral Therapy (B-CBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having a chronic pain condition
- Average pain of > 3 in the last week
- Willingness to engage with study assessments and interventions
- Understanding English or Spanish instructions fluently
- Age 18 and above.
Key exclusion criteria (6 listed)
- Unable to consent because of physical or mental incapacity
- Have previous, formal mindfulness or CBT training (e.g., MBSR)
- Have pain from a current cancer diagnosis
- Unstable illness that may interfere with treatment
- Had surgery 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 adaptation of the traditional MORE program. | Behavioural | Brief Behavioral Intervention #1 |
| Brief Cognitive-Behavioral TherapyB-CBT is a 2-hour adaptation of a traditional 8-week CBT for Chronic Pain manual. | Behavioural | Brief Behavioral Intervention #2 |
Primary outcome
Program Feasibility
Time frame: At the first treatment session [1 hour] and the final treatment session [1 hour]
Feasibility will be assessed by intervention adherence rates (percentage of treatment sessions completed).
Treatment Acceptability
Time frame: Upon completion of the final treatment session [1 hour]
Treatment acceptability will be assessed by an adaptation of the Theoretical Framework of Acceptability scale (TFA).
5 secondary outcomes
Chronic Pain Symptoms
Time frame: Baseline and 2, 6, and 12-week post-treatment follow-ups
Depressive Symptoms
Time frame: Baseline and 2, 6, and 12-week post-treatment follow-ups
Anxiety Symptoms
Time frame: Baseline and 2, 6, and 12-week post-treatment follow-ups
Wellbeing
Time frame: Baseline and 2, 6, and 12-week post-treatment follow-ups
Pain Catastrophizing
Time frame: Baseline and 2, 6, and 12-week post-treatment follow-ups
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 3 Nov 2025.
- Individual participant dataSharing planned: Yes. The study protocol, SAP, ICF, and de-identified IPD will be shared with qualified individuals upon request.
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.
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 and Brief Cognitive-Behavioral Therapy in people with Chronic 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 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: looking for participants now, as of the sponsor's last update on 3 Nov 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?
Program Feasibility (time frame: At the first treatment session [1 hour] and the final treatment session [1 hour]). 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 3 Nov 2025.