Chronic PainPT-IN-MINDNCT05875207
Physical Therapy Integrated With Mindfulness for Patients With Chronic Pain and Opioid Treatment
A study testing Mindfulness based practice in people with Chronic Pain and Pain, Musculoskeletal, run by University of Utah at 2 sites in United States.
Trial summary
This study will use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating mindfulness-based interventions into physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Pain, Musculoskeletal, Opioid Use
- What is being tested?
- Mindfulness based practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2023to 10 Dec 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Aim 2 and 3
- Physical Therapist Inclusion Criteria:
- Employed at least .50 FTE (Full Time Equivalent)
- Self Report managing patients with chronic musculoskeletal conditions
- Physical Therapist Exclusion Criteria:
- -Attended any experiential (i.e., practice sessions with real or simulated patients) mindfulness training to be used for patient care
Show all 20Show fewer
- Attended any patient care specific mindfulness training lasting more than 3 hours.
- Self-report using mindfulness interventions such as savoring and cognitive reappraisal (core components of MORE) as a primary intervention strategy for the majority of their caseload for patients with chronic musculoskeletal conditions.
- Aims 1, 2 and 3
- Patient Inclusion Criteria:
- Age 18-75
- English Speaking
- Diagnosis of musculoskeletal pain condition involving the spine and/or peripheral joint(s)
- Current musculoskeletal pain present for greater than or equal to 3 months.
- Use of prescription opioids for most of the last 90 days (self-report)
- Patient Exclusion Criteria:
- Currently pregnant
- Currently receiving mind-body treatment for musculoskeletal pain from a healthcare provider (e.g. PT, chiropractic, massage therapy, etc)
- Currently receiving treatment for substance use disorder
- Musculoskeletal pain condition related to a fracture or surgical procedure in the past 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32611
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Physical Therapy Integrated With Mindfulness for Patients With Chronic Musculoskeletal Pain and Long-Term Opioid Treatment
This study will use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating mindfulness-based interventions into physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment.
First, researchers will develop a manual for training physical therapists to provide mindfulness-based interventions to patients with chronic musculoskeletal pain and long-term opioid treatment. Next, the researchers will evaluate the competency of physical therapists to provided mindfulness-based interventions after being randomized to one of 3 different mindfulness training arms. Patients scheduled for physical therapy with the randomized physical therapists will be invited to enroll in the study. These patients will be asked to complete a variety of patient reported outcomes including self-reported average pain and the the amount of prescription opioid pain medication taken.
Read the detailed description
Chronic musculoskeletal pain is a leading cause of years lived with disability world-wide and the costliest health condition in the United States. An estimated 20%-30% of persons with chronic musculoskeletal pain use opioids for pain management. In recent years, the prevalence of long-term opioid treatment (LTOT) has increased in patients with musculoskeletal pain. Physical therapy (PT) is a common nonpharmacologic treatment recommended for chronic musculoskeletal pain. Studies suggest PT for musculoskeletal pain may reduce the likelihood of initiating opioid therapy and may protect against LTOT, but the role of PT as part of a multi-modal strategy to manage patients with chronic musculoskeletal pain and LTOT has not been investigated. Combining exercise-based interventions with mindfulness practices is effective for patients with chronic musculoskeletal pain, and engaging in mindfulness practices leads to a reduction in opioid dose in patients with chronic pain and LTOT. This is a feasibility study that will assess effectiveness of physical therapists in managing patients with chronic musculoskeletal pain and LTOT using mindfulness practices. the results of an aim may result in changes to the procedures of a subsequent aim.
This study is organized into three Aims that will be conducted consecutively.
Aim #1: is to refine and manualize physical therapist-led mindfulness-based interventions integrated with evidence-based PT (I-EPT) for patients with chronic musculoskeletal pain and LTOT. Our approach will use semi-structured interviews of 15 patients and 15 physical therapists to refine I-EPT.
Aim #2: Evaluate different intensities of a physical therapist training programs for the refined I-EPT treatment protocol. Our approach will be to randomize 45 physical therapists to 1 of 3 training arms (no training; low-intensity training; high-intensity training).
Aim #3: Evaluate the feasibility of the I-EPT intervention across domains of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. We anticipate 90 patient participants will be enrolled onto the schedules of the randomized physical therapists in Aim 2. Semi-structured qualitative interviews will be conducted. For these interviews there will be separate cohorts of 27 participants from Utah and 27 from Florida. Each cohort will contain approximately 8 physical therapists (4 each from the HIghIT and LowIT programs), 13 patients and 7 between support staff, and clinic managers.
- Conditions
- Chronic Pain, Pain, Musculoskeletal, Opioid Use, Physical Therapy
- Being tested
- Mindfulness based practice, Control/Standard Physical Therapy
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based practiceBehavioural
Physical therapists who are randomized to this arm will receive mindfulness training. This training will teach physical therapists to use the following with their patients: 1) use mindfulness to strengthen self-regulation of habitual and compulsive opioid use, and to mitigate pain by reinterpreting these experiences as innocuous sensory information, 2) use reappraisal to reframe stressors and maladaptive thoughts to decrease negative emotions and engender meaning in life, 3) use savoring of pleasant events and pleasurable sensations to enhance positive emotions and reward and, 4) to integrate mindfulness, reappraisal and savoring with evidence-based physical therapy.
Control/Standard Physical TherapyBehavioural
Physical therapists randomized to this arm will receive no additional training and will provide standard care to patients with chronic musculoskeletal pain and long-term opioid treatment. Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about their pain and opioid use before and after treatment. We plan on enrolling 2 patients for each physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Evidence based physical therapy combined with mindfulness (Low-Intensity) | Experimental | Physical therapists randomized to this arm will receive a manual on how to integrate MORE; mindfulness, mindful reappraisal, and mindful savoring savoring into routine outpatient physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment.
After 4 weeks to review the manual, the physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients.
Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist. Receives: Behavioral: Mindfulness based practice |
| Standard physical therapy | Other | Physical therapists randomized to this arm will deliver routine treatment for someone with chronic musculoskeletal pain and long-term opioid treatment.
Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, during and after treatment. We plan on enrolling 2 patients for each physical therapist. Receives: Behavioral: Control/Standard Physical Therapy |
| Evidence based physical therapy combined with mindfulness (High-Intensity) | Experimental | Physical therapists randomized to this arm will receive 13 hours of training. The first 6 hours consists of prerecorded didactic lectures that the physical therapist can view on their own time. After viewing the lectures, participants will attend 6.25 hours of live experiential instruction to promote trainee competence in providing mindfulness, mindful reappraisal, and mindful savoring after which the participating physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients. .
Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist. Receives: Behavioral: Mindfulness based practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure
Mindfulness Oriented Recovery Enhancement fidelity (Modified MORE-FM) Version 2.0 measure score during post-training competency assessment of physical therapists (physical therapists randomized to High and Low Intensity training groups)
9 item scale - each item scored 0-6. Scores are summed and averaged.
Measured: 6 - 8 weeks after I-EPT live training
Aim #3: Opioid MMEs on Timeline followback (TLFB)
Percentage of TLFBs collected at 12 weeks
The TLFB collects number of morphine milligram equivalents taken by the patient over the past 4 weeks
Measured: 12 weeks
Aim 3: PEG (Pain, Enjoyment, General activity)
Percentage of The Pain, Enjoyment and General Active (PEG) scales collected at 12 weeks
The PEG measures pain intensity, enjoyment of life and general activity each on a 0 - 10 with higher scores indicating worse pain impact. The score is the average of all items.
Measured: 12 weeks
Secondary outcomes (37)
Aim #1 Qualitative Interviews
Semi-structured qualitative interviews will be conducted with patients and physical therapists after they review a mindfulness treatment protocol. Analysis will generate qualitative themes that will be used to modify the treatment protocol in preparation for Aim #2.
Measured: 1 month
Aim #2: Physical therapist retention (competency assessment)
Percent of physical therapists who attend the competency assessment.
Measured: 6 - 8 weeks after I-EPT live training
Aim #2: Randomized physical therapists
Percentage of physical therapists invited who consent to be randomized
Measured: At recruitment
Aim #2: Physical therapist enrollment
Percent of physical therapists presented the study who choose to enroll in the study
Measured: At recruitment
Aim #3: Opioid MMEs on Timeline followback (TLFB)
The TLFB collects number of morphine milligram equivalents taken by the patient over the past 4 weeks
We will calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
Measured: Baseline 6 and 12 weeks
Aim 3: PEG (Pain, Enjoyment, General activity)
The PEG measures pain intensity, enjoyment of life and general activity each on a 0 - 10 with higher scores indicating worse pain impact. The score is the average of all items.
We will calculate the change from baseline to 6 and from baseline to 12 weeks
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Pain Catastrophizing Scale (PCS) short form
Percentage of PCS short form scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
Scores range 0- 24. Higher scores mean greater catastrophizing.
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b (PROMIS-6b)
Percentage of PROMIS-6Bs collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
PROMIS-6b is reported as a T-Score with a mean of 50 and a SD of 10
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported:Patient Reported Outcomes Measurement Information System (PROMIS)PROMIS Sleep Disturbance Short Form 6a
Percentage of PROMIS Sleep Disturbance Short Form 6As collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
Reported as a T-Score with a mean = 50 and a SD = 10
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Patient Health Questionnaire-2 (PHQ-2)
Percentage of PHQ-2 scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
Scores range from 0-6. Higher scores mean greater likelihood of depression
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Generalized Anxiety Disorder-2 (GAD-2)
Percentage of GAD-2s collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
2 items summed range 0 - 6. Higher score mean greater likelihood of anxiety
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Patient Global Impression Scale-Change
Percentage of Patient Global Impression Scale-Change scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
Scores range from 0 - 7 with higher score equating to greater improvement in condition
Measured: 6 and 12 weeks
Aim #3 Patient Reported: Pain Self-Efficacy Questionnaire (PSEQ)
Feasibility: Percentage of PSEQ scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
PSEQ scores range from0 - 60 with higher scores indicating greater levels of confidence in dealing with pain
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Mindfulness-Five Facet Mindfulness Questionnaire (FFMQ)
Feasibility: Percentage of FFMQ scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
FFMQ has15 items and scores range from 15 - 75 higher scores indicate greater mindfulness
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Positive Reappraisal Subscale of Cognitive Emotion Regulation Questionnaire (reappraisal subscale)
Feasibility: Percentage of reappraisal subscale scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
4 items each scored 1 - 5. Higher the score the more positive reappraisal.
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Savoring Beliefs Inventory
Percentage of Savoring Beliefs Inventory scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
24 items - Composite scores are obtained by averaging the subscales after rescoring the negatively worded items. Higher scores equate to greater savoring.
Measured: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Participant-report health care utilization measures
Measure health care use (imaging,, tests, physician visits, medications)
Measured: 4, 8 and 12 weeks
Aim #3 Patient Reported: Short Assessment of Patient Satisfaction
Percentage of Short Assessment of Patient Satisfaction scores collected at 6 and 12 weeks.
We will also calculate the scores at 6 and 12 weeks
7 items. Each item scored 0 - 4 . Reverse score items 1, 3, 5 and 7. Sum scores. Range from 0 (extremely dissatisfied to 7 (extremely satisfied)
Measured: 6 and 12 weeks
Aim #3 Reach: Patients offered and enrolled
The percentage of patients with chronic muscle condition and long-term opioid treatment offered participation who choose to enroll.
Measured: At recruitment
Aim #3 Patient Reported: The International Pain Activity Questionnaire (IPAQ) short form measures physical activity
Percentage of IPAQ scores collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
7 items. Measures metabolic equivalents (METS). Higher score in METS equates to greater activity.
Measured: Baseline, 6 and 12 weeks
Aim #3. Patient Reported: Working Alliance Inventory - Short Short Revised (WAI-SR) Client Version
Percentage of WAI-SR scores collected at 4, 8 and 12 weeks
We will also calculate the change from 4 to 8 weeks and the change from 4 to 12 weeks.
12 items. Higher scores indicate better therapeutic alliance.
Measured: 4, 8 and 12 weeks
Aim #3 Reach: Physical therapists with enrolled patients
The percentage of physical therapists who have a patient enrolled on their schedule
Measured: At recruitment
Aim #3 Effectiveness: REDCap Outcomes Collected
The percentage of all patient reported outcome measures collected using REDCap
Measured: 12 weeks
Aim #3 Adoption: Qualitative interviews
Semi-structured qualitative interviews will be conducted with patient, PT, support staff interviews regarding their lived experience integrating mindfulness and physical therapy. Analysis will generate qualitative themes that will be used to plan for a fully-powered trial.
Measured: 12 weeks
Aim #3 Adoption: Mindfulness Oriented Recovery Enhancement component (MORE)
Percentage of patients enrolled after I-EPT training that report receiving any MORE component.
Measured: 12 weeks
Aim #3 Implementation: Fidelity
Mindfulness Oriented Recovery Enhancement _functional measure (Modified MORE-FM) fidelity measure during patient encounters.
The MORE FM will be completed by a rater which entails the reviewer listening to audio recordings of all patient encounters at the end of the 12 week patient management period.
18-item scale - total scores range from 0 - 114. Scores are summed and averaged.
Measured: 12 weeks
Aim #3 Implementation: Percentage of patients managed by PT
The percentage of patients managed by a single trained physical therapist (don't cross over between physical therapists)
Measured: 12 weeks
Aim #3: Adoption, Maintenance and Implementation: Qualitative Interviews
Semi-structured qualitative interviews will be conducted with patient, PT, support staff, managers and clinic leadership interviews regarding their lived experience integrating mindfulness and physical therapy. These interviews will be used to understand potential barriers and facilitators for future adoption, implementation and maintenance of I-EPT
Measured: 12 weeks
Aim #3: Physical therapist retention
The percentage of physical therapists who participate in the fidelity assessments
Measured: 12 weeks
Aim #3: Patient retention
Percentage of patients managed by study physical therapists who are retained at baseline, 6- and 12-week follow-up.
Measured: baseline, 6 weeks, 12 weeks
Aim #3: Screened patients
Percentage of patients screened who are eligible
Measured: At recruitment
Sleep duration
hours and minutes of actual sleep during past month collected at baseline, 6 and 12 weeks
We will also calculate the change from baseline to 6 weeks and the change from baseline to 12 weeks.
Measured: baseline, 6 and 12 weeks
Aim # 3: Adoption: Patient retention
Percentage of patients managed by study PTs who are retained at baseline, 6- and 12-week follow-up
Measured: baseline, 6 and 12 weeks.
Aim # 3 implementation: Modified version of the Mindfulness Oriented Recovery Enhancement - Functional Measure during patient encounters.
18 items. Scores range from 0 to 216. Higher scores equate to greater fidelity.
Percentage of PTs who score an average of 3 on fidelity assessments
Measured: 12 weeks
Aim #3: Adherence
THe number of recommended patient visits attended
Measured: 12 weeks
Aim # 3 Adherence
Number of minutes spent practicing mindfulness, reappraisal or savoring each day
Measured: weekly for 12 weeks
Aim # 3 Adoption: Patients receiving MORE Components
Percentage of patients enrolled that report receiving any MORE component
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start14 Aug 2023
- Primary completion1 Oct 2025
- Study completion10 Dec 2025
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-site feasibility randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jake Magel, University of Utah
- Investigators
- Jake Magel, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875207
- Sponsor's protocol ID
- 159762
- Other IDs
- 1R01AT012229-01
- Acronym
- PT-IN-MIND
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. The PI will provide data to outside researchers working under an institution with a federal wide assurance 2. De-identified limited access data sets will be created and available for delivery through encrypted, password protected files 3. To protect the confidentiality and privacy of the subjects, investigators granted access to these data must adhere to strict requirements. The Universities of Utah and Florida will define these requirements and establish criteria for access to data by outside researchers (as defined by current NIH regulations). 4. We will make detailed versions of our standard operating procedures available to the scientific and clinical research community. 5. Scientific publications will be the primary means of realeasing the analyses.
Publications
Magel JS, Beneciuk JM, Siantz E, Fritz J, Garland EL, Hanley A, Shen J, Blosser P, Matev T, Gordon AJ. PT-IN-MIND: study protocol for a multisite randomised feasibility trial investigating physical therapy with integrated mindfulness (PT-IN-MIND) for patients with chronic musculoskeletal pain and long-term opioid treatment who attend outpatient physical therapy. BMJ Open. 2024 Jul 30;14(7):e082611. doi: 10.1136/bmjopen-2023-082611.
PubMed 39079926
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy Integrated With Mindfulness for Patients With Chronic Musculoskeletal Pain and Long-Term Opioid Treatment
- ClinicalTrials.gov ID
- NCT05875207
- Acronym / sponsor ID
- PT-IN-MIND / 159762
- Conditions
- Chronic Pain, Pain, Musculoskeletal, Opioid Use, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Florida, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 25 May 2023 (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 use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating mindfulness-based interventions into physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment.
First, researchers will develop a manual for training physical therapists to provide mindfulness-based interventions to patients with chronic musculoskeletal pain and long-term opioid treatment. Next, the researchers will evaluate the competency of physical therapists to provided mindfulness-based interventions after being randomized to one of 3 different mindfulness training arms. Patients scheduled for physical therapy with the randomized physical therapists will be invited to enroll in the study. These patients will be asked to complete a variety of patient reported outcomes including self-reported average pain and the the amount of prescription opioid pain medication taken.
Detailed description
Chronic musculoskeletal pain is a leading cause of years lived with disability world-wide and the costliest health condition in the United States. An estimated 20%-30% of persons with chronic musculoskeletal pain use opioids for pain management. In recent years, the prevalence of long-term opioid treatment (LTOT) has increased in patients with musculoskeletal pain. Physical therapy (PT) is a common nonpharmacologic treatment recommended for chronic musculoskeletal pain. Studies suggest PT for musculoskeletal pain may reduce the likelihood of initiating opioid therapy and may protect against LTOT, but the role of PT as part of a multi-modal strategy to manage patients with chronic musculoskeletal pain and LTOT has not been investigated. Combining exercise-based interventions with mindfulness practices is effective for patients with chronic musculoskeletal pain, and engaging in mindfulness practices leads to a reduction in opioid dose in patients with chronic pain and LTOT. This is a feasibility study that will assess effectiveness of physical therapists in managing patients with chronic musculoskeletal pain and LTOT using mindfulness practices. the results of an aim may result in changes to the procedures of a subsequent aim.
This study is organized into three Aims that will be conducted consecutively.
Aim #1: is to refine and manualize physical therapist-led mindfulness-based interventions integrated with evidence-based PT (I-EPT) for patients with chronic musculoskeletal pain and LTOT. Our approach will use semi-structured interviews of 15 patients and 15 physical therapists to refine I-EPT.
Aim #2: Evaluate different intensities of a physical therapist training programs for the refined I-EPT treatment protocol. Our approach will be to randomize 45 physical therapists to 1 of 3 training arms (no training; low-intensity training; high-intensity training).
Aim #3: Evaluate the feasibility of the I-EPT intervention across domains of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. We anticipate 90 patient participants will be enrolled onto the schedules of the randomized physical therapists in Aim 2. Semi-structured qualitative interviews will be conducted. For these interviews there will be separate cohorts of 27 participants from Utah and 27 from Florida. Each cohort will contain approximately 8 physical therapists (4 each from the HIghIT and LowIT programs), 13 patients and 7 between support staff, and clinic managers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This is a multi-site feasibility randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Evidence based physical therapy combined with mindfulness (Low-Intensity) | Experimental | Behavioral: Mindfulness based practicePhysical therapists randomized to this arm will receive a manual on how to integrate MORE; mindfulness, mindful reappraisal, and mindful savoring savoring into routine outpatient physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment. After 4 weeks to review the manual, the physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients. Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist. |
| Standard physical therapy | Other | Behavioral: Control/Standard Physical TherapyPhysical therapists randomized to this arm will deliver routine treatment for someone with chronic musculoskeletal pain and long-term opioid treatment. Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, during and after treatment. We plan on enrolling 2 patients for each physical therapist. |
| Evidence based physical therapy combined with mindfulness (High-Intensity) | Experimental | Behavioral: Mindfulness based practicePhysical therapists randomized to this arm will receive 13 hours of training. The first 6 hours consists of prerecorded didactic lectures that the physical therapist can view on their own time. After viewing the lectures, participants will attend 6.25 hours of live experiential instruction to promote trainee competence in providing mindfulness, mindful reappraisal, and mindful savoring after which the participating physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients. . Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Aim 2 and 3
- Employed at least .50 FTE (Full Time Equivalent)
- Self Report managing patients with chronic musculoskeletal conditions
- -Attended any experiential (i.e., practice sessions with real or simulated patients) mindfulness training to be used for patient care
- Attended any patient care specific mindfulness training lasting more than 3 hours.
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 based practicePhysical therapists who are randomized to this arm will receive mindfulness training. This training will teach physical therapists to use the following with their patients: 1) use mindfulness to strengthen self-regulation of habitual and compulsive opioid use, and to mitigate pain by reinterpreting these experiences as innocuous sensory information, 2) use reappraisal to reframe stressors and maladaptive thoughts to decrease negative emotions and engender meaning in life, 3) use savoring of pleasant events and pleasurable sensations to enhance positive emotions and reward and, 4) to integrate mindfulness, reappraisal and savoring with evidence-based physical therapy. | Behavioural | Evidence based physical therapy combined with mindfulness (High-Intensity), Evidence based physical therapy combined with mindfulness (Low-Intensity) |
| Control/Standard Physical TherapyPhysical therapists randomized to this arm will receive no additional training and will provide standard care to patients with chronic musculoskeletal pain and long-term opioid treatment. Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about their pain and opioid use before and after treatment. We plan on enrolling 2 patients for each physical therapist. | Behavioural | Standard physical therapy |
Primary outcome
Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure
Time frame: 6 - 8 weeks after I-EPT live training
Mindfulness Oriented Recovery Enhancement fidelity (Modified MORE-FM) Version 2.0 measure score during post-training competency assessment of physical therapists (physical therapists randomized to High and Low Intensity training groups) 9 item scale - each item scored 0-6. Scores are summed and averaged.
Aim #3: Opioid MMEs on Timeline followback (TLFB)
Time frame: 12 weeks
Percentage of TLFBs collected at 12 weeks The TLFB collects number of morphine milligram equivalents taken by the patient over the past 4 weeks
Aim 3: PEG (Pain, Enjoyment, General activity)
Time frame: 12 weeks
Percentage of The Pain, Enjoyment and General Active (PEG) scales collected at 12 weeks The PEG measures pain intensity, enjoyment of life and general activity each on a 0 - 10 with higher scores indicating worse pain impact. The score is the average of all items.
37 secondary outcomes
Aim #1 Qualitative Interviews
Time frame: 1 month
Aim #2: Physical therapist retention (competency assessment)
Time frame: 6 - 8 weeks after I-EPT live training
Aim #2: Randomized physical therapists
Time frame: At recruitment
Aim #2: Physical therapist enrollment
Time frame: At recruitment
Aim #3: Opioid MMEs on Timeline followback (TLFB)
Time frame: Baseline 6 and 12 weeks
Aim 3: PEG (Pain, Enjoyment, General activity)
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Pain Catastrophizing Scale (PCS) short form
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b (PROMIS-6b)
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported:Patient Reported Outcomes Measurement Information System (PROMIS)PROMIS Sleep Disturbance Short Form 6a
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Patient Health Questionnaire-2 (PHQ-2)
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Generalized Anxiety Disorder-2 (GAD-2)
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Patient Global Impression Scale-Change
Time frame: 6 and 12 weeks
Aim #3 Patient Reported: Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Mindfulness-Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Positive Reappraisal Subscale of Cognitive Emotion Regulation Questionnaire (reappraisal subscale)
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Savoring Beliefs Inventory
Time frame: baseline, 6 and 12 weeks
Aim #3 Patient Reported: Participant-report health care utilization measures
Time frame: 4, 8 and 12 weeks
Aim #3 Patient Reported: Short Assessment of Patient Satisfaction
Time frame: 6 and 12 weeks
Aim #3 Reach: Patients offered and enrolled
Time frame: At recruitment
Aim #3 Patient Reported: The International Pain Activity Questionnaire (IPAQ) short form measures physical activity
Time frame: Baseline, 6 and 12 weeks
Aim #3. Patient Reported: Working Alliance Inventory - Short Short Revised (WAI-SR) Client Version
Time frame: 4, 8 and 12 weeks
Aim #3 Reach: Physical therapists with enrolled patients
Time frame: At recruitment
Aim #3 Effectiveness: REDCap Outcomes Collected
Time frame: 12 weeks
Aim #3 Adoption: Qualitative interviews
Time frame: 12 weeks
Aim #3 Adoption: Mindfulness Oriented Recovery Enhancement component (MORE)
Time frame: 12 weeks
Aim #3 Implementation: Fidelity
Time frame: 12 weeks
Aim #3 Implementation: Percentage of patients managed by PT
Time frame: 12 weeks
Aim #3: Adoption, Maintenance and Implementation: Qualitative Interviews
Time frame: 12 weeks
Aim #3: Physical therapist retention
Time frame: 12 weeks
Aim #3: Patient retention
Time frame: baseline, 6 weeks, 12 weeks
Aim #3: Screened patients
Time frame: At recruitment
Sleep duration
Time frame: baseline, 6 and 12 weeks
Aim # 3: Adoption: Patient retention
Time frame: baseline, 6 and 12 weeks.
Aim # 3 implementation: Modified version of the Mindfulness Oriented Recovery Enhancement - Functional Measure during patient encounters.
Time frame: 12 weeks
Aim #3: Adherence
Time frame: 12 weeks
Aim # 3 Adherence
Time frame: weekly for 12 weeks
Aim # 3 Adoption: Patients receiving MORE Components
Time frame: 12 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 21 Jan 2026.
- Derived from this study: PubMed 39079926Magel JS, Beneciuk JM, Siantz E, Fritz J, Garland EL, Hanley A, Shen J, Blosser P, Matev T, Gordon AJ. PT-IN-MIND: study protocol for a multisite randomised feasibility trial investigating physical therapy with integrated mindfulness (PT-IN-MIND) for patients with chronic musculoskeletal pain and long-term opioid treatment who attend outpatient physical therapy. BMJ Open. 2024 Jul 30;14(7):e082611. doi: 10.1136/bmjopen-2023-082611.
- Individual participant dataSharing planned: Yes. 1. The PI will provide data to outside researchers working under an institution with a federal wide assurance 2. De-identified limited access data sets will be created and available for delivery through encrypted, password protected files 3. To protect the confidentiality and privacy of the subjects, investigators granted access to these data must adhere to strict requirements. The Universities of Utah and Florida will define these requirements and establish criteria for access to data by outside researchers (as defined by current NIH regulations). 4. We will make detailed versions of our standard operating procedures available to the scientific and clinical research community. 5. Scientific publications will be the primary means of realeasing the analyses.
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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.
Jake Magel, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based practice in people with Chronic Pain and Pain, Musculoskeletal, run by University of Utah at 2 sites 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 0 inclusion and 20 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure (time frame: 6 - 8 weeks after I-EPT live training). The study lists 3 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 NCT05875207, 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 21 Jan 2026.