Chronic PainMAGICNCT06228755
MAGIC Study: More Access to Group Integrative Care
A study testing Integrative Medicine Group Visit and Implementation Strategies in people with Chronic Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. 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?
- Integrative Medicine Group Visit and Implementation Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to Jun 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
- Staff and clinicians at each clinic who are involved in implementation of the IMGV.
- Only patients who have enrolled in the Integrative medical group visit (IMGV) programs for patients with chronic pain at their Federally Qualified Health Center will be eligible for enrollment in the study. Physicians at each clinical site will determine enrollment criteria for their IMGV program specific to their clinical site--patients who are enrolled in the program will then be invited to participate in the research study.
Who cannot join
- All staff, clinicians, and patients who are not involved in the IMGV at the specific clinical sites are excluded from participation.
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
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27517
About this study
Official title: Scaling-Up Integrative Pain Management in Federally-Qualified Health Centers
Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. The Integrative Medical Group Visit (IMGV) program was developed to offer low-income, diverse patients with chronic pain an introduction to integrative pain management approaches, through a model that is covered by health insurance under existing billing codes. An initial pragmatic randomized control trial found that IMGV led to significant improvement in mental health related quality of life and lower use of high-cost care. However, there has been little research investigating the implementation of IMGV, and none in Federally-Qualified Health Centers (FQHCs), where the program was initially designed to be implemented. In this study, the investigators test strategies to implement IMGV in FQHCs, including training and coaching clinic staff, and measure the effectiveness of the IMGV on health outcomes for patients with chronic pain.
- Conditions
- Chronic Pain
- Being tested
- Integrative Medicine Group Visit, Implementation Strategies
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Medicine Group VisitBehavioural
Also called IMGV
Integrative Medicine Group Visit (IMGV) is a 9-week group visit series co-facilitated by a billing primary care provider and a trained co-facilitator (such as a behavioral health provider, mindfulness instructor, or yoga teacher). The IMGV will be delivered virtually over a secure telehealth platform for 2 hours weekly. The IMGV curriculum focuses on principles of mindfulness-based stress reduction, and includes patient education on pain, insomnia, nutrition, yoga, depression, self-massage, and self-acupressure.
Implementation StrategiesOther
Also called Implementation Strategies Package
Package includes:
- Patient strategies will include an orientation session to introduce patients to the IMGV model.
- Provider strategies include training in delivery of IMGV with continuing education credits. Training may be delivered on-line or in-person. Ongoing coaching in the first year of IMGV implementation will also be offered to providers leading IMGV, to increase self-efficacy to deliver the curriculum, and enhance fidelity.
| Study group | Role | What they receive |
|---|---|---|
| Training, Coaching, and Orientation | Experimental | Clinic personnel will receive training for delivering integrative medicine group visits (IMGV) and ongoing coaching in delivering IMGV for patients with chronic pain. Clinic patients will participate in orientation and the 9-week IMGV. Receives: Behavioral: Integrative Medicine Group Visit; Other: Implementation Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach: Total Patients Reached
Number of patients who enroll in IMGV at each clinical site.
Measured: through study completion, a total of up to 3 years
Reach: Race of Patients Reached
Race of patients who enroll in IMGV at each clinical site.
Measured: through study completion, a total of up to 3 years
Reach: Ethnicity of Patients Reached
Ethnicity of patients who enroll in IMGV at each clinical site.
Measured: through study completion, a total of up to 3 years
Reach: Gender of Patients Reached
Gender of patients who enroll in IMGV at each clinical site.
Measured: through study completion, a total of up to 3 years
Reach: Age of Patients Reached
Age of patients who enroll in IMGV at each clinical site.
Measured: through study completion, a total of up to 3 years
Adoption
Number of clinic staff willing to form an implementation team to participate in delivering and implementing the IMGV at each clinical site.
Measured: through study completion, a total of up to 3 years
Acceptability: Patients
Number of patients who perceive the IMGV to be acceptable based on qualitative data analysis.
Measured: within 1 month of final IMGV session participation, approximately 10 weeks
Acceptability: Clinic Personnel
Number of clinic personnel who perceive the implementation of IMGV to be acceptable based on qualitative data analysis.
Measured: within 1 month of final IMGV session participation, approximately 10 weeks
Cost: Patient Perspective
Total cost of participation in the IMGV from the perspective of patients (ie total cost of time, accessing technology, childcare, out-of-pocket costs).
Measured: within 1 month of final IMGV session participation, approximately 10 weeks
Cost: Clinic Perspective
Total cost of implementation in the IMGV from the perspective of the clinic (ie total cost of staff time to implement the program, material costs).
Measured: within 1 month of final IMGV session participation, approximately 10 weeks
Fidelity
Score on the Integrative Medical Group Visit (IMGV) Fidelity rating scale, measuring the extent to which core functions of the IMGV were delivered as intended by the clinic personnel. The scale includes 5 questions using a 0-3 point scale. Questions measure the constructs: fostering a safe and positive environment, fostering social support through the group, providing evidence-based medical advice, fostering collaboration, and providing access to integrative therapy experiential practice. Total range is from 0-15 with 0 representing the lowest and 15 representing the highest possible fidelity.
Measured: Through completion of IMGV delivery, a total of up to two years
Maintenance: 6 months
Number of IMGV sessions held at the clinic at 6 months since the first IMGV session at that clinic.
Measured: Six months after the first IMGV session at clinic
Maintenance: 12 months
Number of IMGV sessions held at the clinic at 12 months since the first IMGV session at that clinic.
Measured: Twelve months after the first IMGV session at clinic
Secondary outcomes (9)
Change in Physical Function
Patient report of physical function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 Physical Function Short Form 4-a. This includes 4 questions assessing chores, ability to use stairs, walking, and running errands on a 5-point scale with end points of "without any difficulty" and "unable to do." Raw total scores range from 4-20, where a higher score correlates to a better outcome for physical function.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Anxiety
Patient report of anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Anxiety Short Form 4-a. This includes 4 questions assessing feeling fearful, ability to focus on anything other than anxiety, worries, and feeling uneasy in the past 7 days on a 5-point scale with end points of "never" and "always." Higher scores reflect more difficulty. Raw total scores range from 4-20, where a higher score correlates to a worse outcome for anxiety.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Depression
Patient report of depression will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a. This includes 4 questions assessing feeling worthless, helpless, depressed, or hopeless in the past 7 days on a 5-point scale with end points of "never" and "always." Raw total scores range from 4-20, where a higher score correlates to a worse outcome for depression.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Fatigue
Patient report of fatigue will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 -Fatigue - Short Form 4a. This includes 4 questions assessing feeling fatigued, had trouble starting things because of feeling tired, run-down, and fatigued on average in the past 7 days on a 5-point scale with end points of "not at all" and "very much." Raw total scores range from 4-20, where a higher score correlates to a worse outcome for fatigue.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Sleep Disturbance
Patient report of sleep disturbance will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 -Sleep Disturbance - Short form 4a. This includes 4 questions assessing sleep quality, sleep was refreshing, problem with sleep, or difficulty falling asleep on average in the past 7 days on a 5-point scale with end points of "very poor" "very good" sleep quality and "not at all" and "very much" for all other questions. Raw total scores range from 4-20, where a higher score correlates to a worse outcome for sleep disturbance.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Ability to Participate in Social Roles and Activities
Patient report of ability to participate in social roles and activities will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Ability to Participate in Social Roles and Activities- Short Form 4a. This includes 4 questions assessing trouble doing regular leisure activities with others, trouble doing family activities, trouble doing usual activities at work, and trouble doing activities with friend on a 5-point scale with end points of "never" and "always." Raw total scores range from 4-20, where a higher score correlates to a better outcome for ability to participate in social roles and activities.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Pain Interference
Patient report of pain interference will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.1 - Pain Interference - Short Form 4a. This includes 4 questions assessing pain interfering with day to day activities, work around the home, ability to participate in social activities, and household chores in the past 7 days on a 5-point scale with end points of "not at all" and "very much." Higher scores reflect more difficulty. Raw total scores range from 4-20, where a higher score correlates to a better outcome for pain interference.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Pain Intensity
Change in pain intensity will be measured before and after participation in the IMGV and assessed by the Pain Intensity sub-scale of the PROMIS-29 instrument. Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome.
Measured: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Pain Medication Use
Total pain medication use will be compared through data from the electronic health record (comparing medications listed before initiating and after participation in IMGV).
Measured: Assessments will be conducted within 4 weeks of the final IMGV session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start26 Jan 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Isabel J Roth, DrPH, MS, Principal investigator, University of North Carolina at Chapel Hill School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228755
- Sponsor's protocol ID
- 23-2481
- Other IDs
- 5K01AT011578-02
- Acronym
- MAGIC
- Status last verified
- May 2026
- First submitted
- 16 Jan 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling-Up Integrative Pain Management in Federally-Qualified Health Centers
- ClinicalTrials.gov ID
- NCT06228755
- Acronym / sponsor ID
- MAGIC / 23-2481
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jan 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.
Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. The Integrative Medical Group Visit (IMGV) program was developed to offer low-income, diverse patients with chronic pain an introduction to integrative pain management approaches, through a model that is covered by health insurance under existing billing codes. An initial pragmatic randomized control trial found that IMGV led to significant improvement in mental health related quality of life and lower use of high-cost care. However, there has been little research investigating the implementation of IMGV, and none in Federally-Qualified Health Centers (FQHCs), where the program was initially designed to be implemented. In this study, the investigators test strategies to implement IMGV in FQHCs, including training and coaching clinic staff, and measure the effectiveness of the IMGV on health outcomes for patients with chronic pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training, Coaching, and Orientation | Experimental | Behavioral: Integrative Medicine Group Visit, Other: Implementation StrategiesClinic personnel will receive training for delivering integrative medicine group visits (IMGV) and ongoing coaching in delivering IMGV for patients with chronic pain. Clinic patients will participate in orientation and the 9-week IMGV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Staff and clinicians at each clinic who are involved in implementation of the IMGV.
- Only patients who have enrolled in the Integrative medical group visit (IMGV) programs for patients with chronic pain at their Federally Qualified Health Center will be eligible for enrollment in the study. Physicians at each clinical site will determine enrollment criteria for their IMGV program specific to their clinical site--patients who are enrolled in the program will then be invited to participate in the research study.
Key exclusion criteria (1 listed)
- All staff, clinicians, and patients who are not involved in the IMGV at the specific clinical sites are excluded from 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 |
|---|---|---|
| Integrative Medicine Group VisitAlso: IMGVIntegrative Medicine Group Visit (IMGV) is a 9-week group visit series co-facilitated by a billing primary care provider and a trained co-facilitator (such as a behavioral health provider, mindfulness instructor, or yoga teacher). The IMGV will be delivered virtually over a secure telehealth platform for 2 hours weekly. The IMGV curriculum focuses on principles of mindfulness-based stress reduction, and includes patient education on pain, insomnia, nutrition, yoga, depression, self-massage, and self-acupressure. | Behavioural | Training, Coaching, and Orientation |
| Implementation StrategiesAlso: Implementation Strategies PackagePackage includes: * Patient strategies will include an orientation session to introduce patients to the IMGV model. * Provider strategies include training in delivery of IMGV with continuing education credits. Training may be delivered on-line or in-person. Ongoing coaching in the first year of IMGV implementation will also be offered to providers leading IMGV, to increase self-efficacy to deliver the curriculum, and enhance fidelity. | Other | Training, Coaching, and Orientation |
Primary outcome
Reach: Total Patients Reached
Time frame: through study completion, a total of up to 3 years
Number of patients who enroll in IMGV at each clinical site.
Reach: Race of Patients Reached
Time frame: through study completion, a total of up to 3 years
Race of patients who enroll in IMGV at each clinical site.
Reach: Ethnicity of Patients Reached
Time frame: through study completion, a total of up to 3 years
Ethnicity of patients who enroll in IMGV at each clinical site.
Reach: Gender of Patients Reached
Time frame: through study completion, a total of up to 3 years
Gender of patients who enroll in IMGV at each clinical site.
Reach: Age of Patients Reached
Time frame: through study completion, a total of up to 3 years
Age of patients who enroll in IMGV at each clinical site.
Adoption
Time frame: through study completion, a total of up to 3 years
Number of clinic staff willing to form an implementation team to participate in delivering and implementing the IMGV at each clinical site.
Acceptability: Patients
Time frame: within 1 month of final IMGV session participation, approximately 10 weeks
Number of patients who perceive the IMGV to be acceptable based on qualitative data analysis.
Acceptability: Clinic Personnel
Time frame: within 1 month of final IMGV session participation, approximately 10 weeks
Number of clinic personnel who perceive the implementation of IMGV to be acceptable based on qualitative data analysis.
Cost: Patient Perspective
Time frame: within 1 month of final IMGV session participation, approximately 10 weeks
Total cost of participation in the IMGV from the perspective of patients (ie total cost of time, accessing technology, childcare, out-of-pocket costs).
Cost: Clinic Perspective
Time frame: within 1 month of final IMGV session participation, approximately 10 weeks
Total cost of implementation in the IMGV from the perspective of the clinic (ie total cost of staff time to implement the program, material costs).
Fidelity
Time frame: Through completion of IMGV delivery, a total of up to two years
Score on the Integrative Medical Group Visit (IMGV) Fidelity rating scale, measuring the extent to which core functions of the IMGV were delivered as intended by the clinic personnel. The scale includes 5 questions using a 0-3 point scale. Questions measure the constructs: fostering a safe and positive environment, fostering social support through the group, providing evidence-based medical advice, fostering collaboration, and providing access to integrative therapy experiential practice. Total range is from 0-15 with 0 representing the lowest and 15 representing the highest possible fidelity.
Maintenance: 6 months
Time frame: Six months after the first IMGV session at clinic
Number of IMGV sessions held at the clinic at 6 months since the first IMGV session at that clinic.
Maintenance: 12 months
Time frame: Twelve months after the first IMGV session at clinic
Number of IMGV sessions held at the clinic at 12 months since the first IMGV session at that clinic.
9 secondary outcomes
Change in Physical Function
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Anxiety
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Depression
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Fatigue
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Sleep Disturbance
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Ability to Participate in Social Roles and Activities
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Pain Interference
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Pain Intensity
Time frame: Pre-assessments will be conducted within 4 weeks of the first IMGV session, Post assessments will be conducted within 4 weeks of the final IMGV session.
Change in Pain Medication Use
Time frame: Assessments will be conducted within 4 weeks of the final IMGV session.
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Isabel J Roth, DrPH, MS principal investigator
University of North Carolina at Chapel Hill School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Medicine Group Visit and Implementation Strategies in people with Chronic Pain, run by University of North Carolina, Chapel Hill 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 2 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: enrolling by invitation, as of the sponsor's last update on 26 Jun 2026. 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?
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?
Reach: Total Patients Reached (time frame: through study completion, a total of up to 3 years). The study lists 13 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 26 Jun 2026.