MAGIC Study: More Access to Group Integrative Care (MAGIC)

June 24, 2026 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina at Chapel Hill School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • All staff, clinicians, and patients who are not involved in the IMGV at the specific clinical sites are excluded from participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Training, Coaching, and Orientation
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.
Behavioral: Integrative Medicine Group Visit
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.
Other Names:
  • IMGV
Other: Implementation Strategies

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.
Other Names:
  • Implementation Strategies Package

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, a total of up to 3 years
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.
through study completion, a total of up to 3 years
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.
through study completion, a total of up to 3 years
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.
through study completion, a total of up to 3 years
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.
through study completion, a total of up to 3 years
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.
through study completion, a total of up to 3 years
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.
within 1 month of final IMGV session participation, approximately 10 weeks
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.
within 1 month of final IMGV session participation, approximately 10 weeks
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).
within 1 month of final IMGV session participation, approximately 10 weeks
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).
within 1 month of final IMGV session participation, approximately 10 weeks
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.
Through completion of IMGV delivery, a total of up to two years
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.
Six months after the first IMGV session at 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.
Twelve months after the first IMGV session at clinic

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
Total pain medication use will be compared through data from the electronic health record (comparing medications listed before initiating and after participation in IMGV).
Assessments will be conducted within 4 weeks of the final IMGV session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabel J Roth, DrPH, MS, University of North Carolina at Chapel Hill School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-2481
  • 5K01AT011578-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

beginning 9 and continuing for 36 months following publication

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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