protocolSection identificationModule nctId: NCT06327542, orgStudyIdInfo id: 22-37078B, secondaryIdInfos id: 1R61MD018333, type: NIH, link: https://reporter.nih.gov/quickSearch/1R61MD018333, briefTitle: Group-based Integrative Pain Management in Primary Care Safety Net Clinics, acronym: IPMP+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: 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 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., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 2x2 factorial trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Group Acupuncture, interventions name: Integrative Group Medical Visits, outcomesModule primaryOutcomes measure: Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function., primaryOutcomes measure: Change in Social support and Pain Questionnaire (SPQ), secondaryOutcomes measure: Change in average pain intensity on the 0-10 numeric rating scale, secondaryOutcomes measure: 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., secondaryOutcomes measure: Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b, secondaryOutcomes measure: Change in Internalized Stigma of Chronic Pain (ISCP) survey, secondaryOutcomes measure: Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a, secondaryOutcomes measure: Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ), secondaryOutcomes measure: Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form, secondaryOutcomes measure: Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2), secondaryOutcomes measure: Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC), secondaryOutcomes measure: Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, secondaryOutcomes measure: Change in experiences of discrimination in healthcare, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tom Waddell Urban Health Clinic, city: San Francisco, state: California, zip: 94102, country: United States, contacts name: Jesse Wennik, NP, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False