protocolSection identificationModule nctId: NCT06292637, orgStudyIdInfo id: 2020-1484, secondaryIdInfos id: A545000, type: OTHER, domain: UW Madison, secondaryIdInfos id: NUR/FACULTY AFFAIRS/ADMIN, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 4/4/2024, type: OTHER, domain: UW Madison, secondaryIdInfos id: 1R01HS029477-01, type: AHRQ, link: https://reporter.nih.gov/quickSearch/1R01HS029477-01, briefTitle: Cognitive Behavioral and Faith Fellowship to Improve Thy Health, acronym: CB-FAITH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: Agency for Healthcare Research and Quality (AHRQ), descriptionModule briefSummary: Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized stepped wedge design (R-SWD), a type of cluster randomized controlled trial, will be used to randomize a cluster (church groups with a group of 10 participants), not individual subjects.At the start of a R-SWD, all clusters begin as control groups. At certain time points during the course of the trial, some of the clusters are randomly selected to be switched to the CB-FAITH treatment, with all clusters eventually crossing over to receive the treatment. The sample will be comprised of 12 groups, each with 10 individuals (N=120)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH), outcomesModule primaryOutcomes measure: Patient Health Questionnaire, primaryOutcomes measure: Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR), secondaryOutcomes measure: Multidimensional Measure of Religious Involvement (MMRI) score, secondaryOutcomes measure: Client Satisfaction Inventory (CSI) score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Baptist Church, city: Madison, state: Wisconsin, zip: 53711-3800, country: United States, contacts name: Anthony Wade, role: CONTACT, phone: 608-278-1430, email: a.wade4@hotmail.com, contacts name: Anthony Wade, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, locations facility: The Board of Regents of the UW System, city: Madison, state: Wisconsin, zip: 53715-1218, country: United States, contacts name: Earlise Ward, PhD, role: CONTACT, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False