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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61MD018333 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed pilot study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients.
Background: The proposed pilot study seeks to address chronic pain disparities in racially diverse, socioeconomically disadvantaged individuals by optimizing multimodal pain management provided in primary care safety net clinics. Multilevel barriers exist in primary care settings where socioeconomically disadvantaged patients are most often treated. Lack of access to multimodal and nonpharmacologic care at the organizational level alongside provider bias and other forms of discrimination at the interpersonal level contribute to unequal assessment, treatment, and quality of pain care. Stigmatization cross-cuts all levels and is closely linked with social isolation common among individuals with chronic pain. Group-based models are a promising multilevel approach to increase access to non-pharmacologic therapies, address time constraints that contribute to disparities in pain care, improve patient-clinician communication, and provide social support among safety net patients with chronic pain.
Methods: This pilot study uses mixed methods and a pragmatic 2x2 randomized factorial trial to test two group-based models: integrative group medical visits (IGMV) and group acupuncture. Study interventions include 12 weekly sessions based on existing protocols tested in primary care safety net settings. IGMV includes pain education, social and behavioral support, and mind-body approaches (meditation, yoga). Group acupuncture uses responsive manualization, allowing for a standardized yet individualized treatment. During this pilot study, a panel of national experts and patient stakeholders will refine and optimize the structure, process, and content of IGMV aimed at reducing social isolation and intersectional stigma as part of pain management. Interventions will be piloted in 40 English or Spanish speaking patients with chronic pain at two primary care safety net clinics. Study procedures will be tested and adapted for a larger scale trial. The larger study will test the hypotheses that compared with usual care, each study intervention improves pain interference and social isolation (primary outcomes), and that the two combined have synergistic effects mediated by increased social support and decreased impact of intersectional stigma among safety net patients with chronic pain.
Significance: Multilevel approaches are needed to advance health equity in pain management. The proposed study will contribute to knowledge of group-based integrative pain management co-located in primary care to address disparities in pain care for socioeconomically vulnerable populations. The study receives support from the Helping to End Addiction Long-term® (HEAL) Initiative (https://heal.nih.gov/).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care | No Intervention | Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy. | |
| group acupuncture | Experimental | Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting. |
|
| Integrative Group Medical Visits (IGMV) | Experimental | IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support. |
|
| group acupuncture and IGMV | Experimental | Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group acupuncture | Other | Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eligible Patients Who Are Randomized | Percentage of patients with confirmed eligibility who are randomized | Randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Randomized Participants Who Complete the Study | Retention as percentage of randomized who complete 3-month follow up survey | 3-month follow up |
| Intervention Adherence | average number of intervention sessions attended |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference. | 3-month follow up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Chao, DrPH, MPA | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Waddell Urban Health Clinic | San Francisco | California | 94102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40817732 | Derived | Thompson-Lastad A, Wennik J, Swedlow P, Wu J, Hartogensis W, Jackson JLN, Chao MT. Group-Based Integrative Pain Management: Feasibility of a Factorial Randomized Trial in Safety-Net Primary Care. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251360113. doi: 10.1177/21501319251360113. Epub 2025 Aug 16. |
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Data from the study will comply with NIH Helping to End Addiction Long term (HEAL) policies on data sharing, which will include depositing deidentified data in a data repository.
to be determined based on NIH HEAL policies
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit. |
| FG001 | Group Acupuncture | Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting, dosing similar to prior research. Acupuncture point selection and other treatment details will follow responsive manualization, a protocol developed for the largest clinical trial of group acupuncture to date. A licensed acupuncturist experienced with administering group acupuncture treatments will determine each participant's traditional Chinese medicine diagnosis and administer 8-10 acupuncture needles on distal points of participant's body (below the knees, from the elbows to the hands, and on the head). Duration of assessment, needle placement and retention will be 30-45 minutes. Details of acupuncture treatments (e.g., frequency and duration, traditional Chinese medicine diagnosis, number of needles and points used) will be documented in electronic health records. Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. |
| FG002 | Integrative Group Medical Visits (IGMV) | IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support. Non-pharmacologic approaches are based on guidelines on chronic pain management; feedback of experts, staff, and patients; and feasibility with the greatest potential to benefit participants. Participants will receive a binder with educational materials. Integrative Group Medical Visits: IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. |
| FG003 | Group Acupuncture and IGMV | Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above. Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. Integrative Group Medical Visits: IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Eligible Patients Who Are Randomized | Percentage of patients with confirmed eligibility who are randomized | Posted | Count of Participants | Participants | Randomization |
|
|
3 months
patients were asked to report any side effects at each treatment sessions and at data collection timepoints
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit. |
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Small pilot trial with a focus on feasibility for larger scale 2x2 factorial trial. Patient-reported outcomes were assessed as exploratory, not as confirmatory analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Chao, DrPH, MPA, Principal Investigator | University of California, San Francisco | 415-353-7749 | Maria.Chao@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 4, 2024 | Dec 5, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D057545 | Social Stigma |
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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2x2 factorial trial
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|
| Integrative Group Medical Visits | Other | IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. |
|
| 12 weeks |
| Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | Self-reported social isolation will be measured using the 8-item PROMIS scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of social isolation. | 3-month follow up |
| Social Support in Chronic Pain Scale | Social Support in Chronic Pain will be measured using Van Der Lugts' 6-item Social Support in Chronic Pain Scale. Total scores range from 0 to 24, with higher scores indicating greater levels of social support. | 3-month follow up |
| Average Pain Intensity on the 0-10 Numeric Rating Scale | Pain intensity in the past 7 days will be measured on the numeric rating scale (NRS), the score ranges from 0-10, with zero indicating no pain and 10 indicating the worst pain imaginable. | 3-month follow up |
| Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) | Patient belief about treatment efficacy will be measured using a single item patient global impression of change (PGIC). Total score rates from 1 (very much worse) to 7 (very much improved) | 3-month follow up |
| BG001 | Group Acupuncture | Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting, dosing similar to prior research. Acupuncture point selection and other treatment details will follow responsive manualization, a protocol developed for the largest clinical trial of group acupuncture to date. A licensed acupuncturist experienced with administering group acupuncture treatments will determine each participant's traditional Chinese medicine diagnosis and administer 8-10 acupuncture needles on distal points of participant's body (below the knees, from the elbows to the hands, and on the head). Duration of assessment, needle placement and retention will be 30-45 minutes. Details of acupuncture treatments (e.g., frequency and duration, traditional Chinese medicine diagnosis, number of needles and points used) will be documented in electronic health records. Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. |
| BG002 | Integrative Group Medical Visits (IGMV) | IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support. Non-pharmacologic approaches are based on guidelines on chronic pain management; feedback of experts, staff, and patients; and feasibility with the greatest potential to benefit participants. Participants will receive a binder with educational materials. Integrative Group Medical Visits: IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. |
| BG003 | Group Acupuncture and IGMV | Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above. Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. Integrative Group Medical Visits: IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain Interference (8-item NIH Patient Reported Outcomes Measurement Information System) | Self-reported pain interference measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference. | Mean | Standard Deviation | units on a scale |
|
|
| Secondary | Percentage of Randomized Participants Who Complete the Study | Retention as percentage of randomized who complete 3-month follow up survey | Posted | Count of Participants | Participants | 3-month follow up |
|
|
|
| Secondary | Intervention Adherence | average number of intervention sessions attended | for usual care, this measure is not applicable | Posted | Mean | Standard Deviation | intervention sessions | 12 weeks |
|
|
|
| Other Pre-specified | Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference. | all participants who completed three-month follow up survey | Posted | Mean | Standard Deviation | score on a scale | 3-month follow up |
|
|
|
| Other Pre-specified | Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | Self-reported social isolation will be measured using the 8-item PROMIS scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of social isolation. | all participants who completed three-month follow up survey | Posted | Mean | Standard Deviation | score on a scale | 3-month follow up |
|
|
|
| Other Pre-specified | Social Support in Chronic Pain Scale | Social Support in Chronic Pain will be measured using Van Der Lugts' 6-item Social Support in Chronic Pain Scale. Total scores range from 0 to 24, with higher scores indicating greater levels of social support. | all participants who completed three-month follow up survey | Posted | Mean | Standard Deviation | score on a scale | 3-month follow up |
|
|
|
| Other Pre-specified | Average Pain Intensity on the 0-10 Numeric Rating Scale | Pain intensity in the past 7 days will be measured on the numeric rating scale (NRS), the score ranges from 0-10, with zero indicating no pain and 10 indicating the worst pain imaginable. | all participants who completed three-month follow up survey | Posted | Mean | Standard Deviation | score on a scale | 3-month follow up |
|
|
|
| Other Pre-specified | Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) | Patient belief about treatment efficacy will be measured using a single item patient global impression of change (PGIC). Total score rates from 1 (very much worse) to 7 (very much improved) | Participants who completed 3-month follow up | Posted | Mean | Standard Deviation | units on a scale | 3-month follow up |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Group Acupuncture | Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting, dosing similar to prior research. Acupuncture point selection and other treatment details will follow responsive manualization, a protocol developed for the largest clinical trial of group acupuncture to date. A licensed acupuncturist experienced with administering group acupuncture treatments will determine each participant's traditional Chinese medicine diagnosis and administer 8-10 acupuncture needles on distal points of participant's body (below the knees, from the elbows to the hands, and on the head). Duration of assessment, needle placement and retention will be 30-45 minutes. Details of acupuncture treatments (e.g., frequency and duration, traditional Chinese medicine diagnosis, number of needles and points used) will be documented in electronic health records. Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Integrative Group Medical Visits (IGMV) | IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support. Non-pharmacologic approaches are based on guidelines on chronic pain management; feedback of experts, staff, and patients; and feasibility with the greatest potential to benefit participants. Participants will receive a binder with educational materials. Integrative Group Medical Visits: IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Group Acupuncture and IGMV | Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above. Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. Integrative Group Medical Visits: IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D012919 | Social Behavior |
| D001519 | Behavior |