[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07524751":3,"trial-entities:NCT07524751":96,"trial-summary:NCT07524751":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":69,"locations":72,"central_contacts":88,"overall_officials":93,"references":94,"see_also_links":95},"NCT07524751","4R00MD017254","Culturally Adapted Pain Management for Indigenous Peoples","Culturally Adapted Pain Management for Indigenous Peoples in the Pacific Northwest (CAP-I)","RECRUITING","2028-11-30","2026-06","2026-06-11","2026-06-15","University of California, San Diego","OTHER",false,"The proposed study involves a randomized feasibility pilot trial of a culturally adapted psychological intervention for chronic pain for American Indian\u002FAlaska Native (AI\u002FAN) individuals receiving care for pain at the Portland Area Indian Health Service - Yakama Service Unit. The study will provide information on whether or not it is feasible to conduct a future fully-powered randomized controlled trial.","The prevalence of chronic pain is higher among American Indian\u002FAlaskan Native (AI\u002FAN) people than any other group in the United States. This proposed study aims to begin the process of developing a culturally-adapted psychological intervention for chronic pain among AI\u002FAN individuals receiving care for pain at the Portland Area Indian Health Service - Yakama Service Unit. The K99 phase focused on the development of the intervention and the R00 entails a feasibility randomized pilot trial. The current study (i.e., the R00 phase) aims to assess the feasibility of conducting a future randomized controlled trial with the newly developed culturally-adapted psychological intervention for chronic pain.",[19],"Chronic Pain",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Braided Skills for Managing Pain","The intervention is a \"braiding\" or integration of Indigenous, Western, and Eastern beliefs and practices. Pain management skills involve evidence-based psychological techniques of behavioral activation, mindfulness meditation, relaxation techniques, and cognitive restructuring. Indigenous healing practices related to pain involve land-based healing, reconnecting with community, spirituality, narrative sharing, journaling, and restoration of cultural practices (e.g., eating Native foods, ceremonies).",[34],"Active Treatment",[36],{"measure":37,"description":38,"timeFrame":39},"Recruitment","Successful recruitment is defined by the randomization of 30 study participants","Until the end of the recruitment phase (once all study participants have been recruited, an estimated 1-2 years).",[41,45,49],{"measure":42,"description":43,"timeFrame":44},"Treatment adherence","Treatment adherence will be successful if the average treatment adherence rate is at least 70%","From the start of treatment to the end of treatment at 7 weeks.",{"measure":46,"description":47,"timeFrame":48},"Treatment satisfaction","Treatment will be considered satisfactory if the mean on the Patient Global Assessment of Treatment Satisfaction questionnaire is 3 and above.","Post-treatment assessment, conducted after completion of the 7 weeks of treatment.",{"measure":50,"description":51,"timeFrame":48},"Cultural congruency","Cultural congruency of treatment will be considered successful if qualitative interviews suggest themes of cultural congruency","ALL","18 Years",null,{"inclusion":56,"exclusion":62,"raw_text":68},[57,58,59,60,61],"at least 18 years of age","identify as AI\u002FAN (or by another preferred name, such Native American, Native, and\u002For Indigenous)","have at least one diagnosis consistent with chronic pain and\u002For meet criteria for chronic pain diagnosis at enrollment (i.e., experience pain for \\> 50% in the past 3 months that interferes with daily functioning)","possess the ability to speak and understand English","have access to a mode of communication for contact, such as a telephone, for study purposes",[63,64,65,66,67],"significant cognitive impairment","current uncontrolled serious psychological issues (e.g., schizophrenia, bipolar disorder)","active medical treatment for malignant conditions (e.g., cancer)","active suicidality with intent","active alcohol and\u002For substance abuse","Inclusion Criteria:\n\n* at least 18 years of age\n* identify as AI\u002FAN (or by another preferred name, such Native American, Native, and\u002For Indigenous)\n* have at least one diagnosis consistent with chronic pain and\u002For meet criteria for chronic pain diagnosis at enrollment (i.e., experience pain for \\> 50% in the past 3 months that interferes with daily functioning)\n* possess the ability to speak and understand English\n* have access to a mode of communication for contact, such as a telephone, for study purposes\n\nExclusion Criteria:\n\n* significant cognitive impairment\n* current uncontrolled serious psychological issues (e.g., schizophrenia, bipolar disorder)\n* active medical treatment for malignant conditions (e.g., cancer)\n* active suicidality with intent\n* active alcohol and\u002For substance abuse",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"Portland Area Indian Health Services - Yakama Service Unit","Yakima","Washington","98948","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Ryan Pett, PharmD, MPH, BCPS","CONTACT","509-865-1728","Ryan.Pett@ihs.gov",{"lat":86,"lon":87},46.60207,-120.5059,[89],{"name":90,"role":82,"phone":91,"email":92},"Andrea K Newman, PhD","253-271-4289","a7newman@health.ucsd.edu",[],[],[],{"nct_id":4,"conditions":97,"biomarkers":98},[19],[],{"nct_id":4,"found":15,"summary":54,"prompt_version":54}]