Trauma-Informed Intervention for Rheumatoid Arthritis on Blackfeet Nation

Trauma-informed Intervention for Rheumatoid Arthritis on Blackfeet Nation

The goal of this study is to determine whether an intervention grounded in Blackfeet culture improves systemic inflammation and symptoms of arthritis in Blackfeet People with rheumatoid arthritis. The intervention is designed to increase conectedness of Blackfeet people to Blackfeet culture and community. The intervention will consist of one week of meetings in which Blackfeet Elders talk about Blackfeet historical trauma, culture, traditions and cerimonies. The second week of the intervention consists of visiting Blackfeet sacred sites, guided by Blackfeet Elders. Participants will complete surveys to determine their conectedness to Blackfeet Culture, level of stress, Adverse Childhood Experiences Score (ACES) and arthritis symptoms. Participants will also be evaluated for clinical severity of arthritis and biomarkers of systemic inflammation. Participants will be evaluated pre- and post-intervention as well as 6 months post-intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Culturally Grounded Intervention

Detailed Description

The prevalence rate of rheumatoid arthritis (RA) in Blackfeet Nation members is among the highest in North America. With our current NARCH funding, we have found that cultural connectiveness in members of the Blackfeet Nation ameliorated the pro-inflammatory effects associated with high exposure to adverse childhood experiences (ACES). This raises the question of whether improving cultural connectedness might be an effective, trauma-informed approach to improve function, outcome, and/or a sense of well-being in individuals with rheumatic diseases such as RA. The plausibility of taking this approach is grounded on the high exposure rates to ACEs in individuals living on and near the Blackfeet Reservation and the strong association between ACEs and systemic inflammation. Thus, we will test the hypothesis that a trauma-informed intervention aimed to improve cultural connectiveness will improve subjective and objective features of RA in individuals living on or near the Blackfeet Nation Reservation. This research project will serve the overall goal of the NARCH grant by: (1) building on past NARCH research to better understand physical and mental health of the Blackfeet Nation; (2) building capacity for health research at BCC-CCM through engagement and training of BCC students, driving scholarly productivity of BCC faculty, and building new inter-institutional collaborations; and (3) generate compelling results to address health concerns for the Blackfeet Nation. We propose 2 aims that can be accomplished over the time frame of this application:

Specific Aim 1: We will test the effects of a 2-week intervention designed to connect individuals with RA more strongly to Blackfeet language, cultures, ceremonies, and land. This pilot intervention of limited size will consist of assessing the clinical symptoms of RA, ACES scores, and biomarkers of inflammation before and immediately after the culturally grounded intervention. This pilot will inform a second, more encompassing intervention in aim 2. Specific Aim 2: We will test the hypothesis that a 2-week intervention to improve cultural connectedness in individuals with RA living on or near the Blackfeet Nation result in objective changes to pro-inflammatory markers, including markers associated with disease activity in RA. We believe developing an intervention which could reduce systemic inflammation could not only ameliorate symptoms of RA but possibly other inflammation-mediated diseases as well.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betty Matthews; Phone Number: 14068454583; Email: b_mathews@bfcc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Diagnosis or self reporting of rheumatoid arthritis or use of rheumatoid arthritis medications.

Self reported Blackfeet heritage. -

Exclusion Criteria: Children under 18 years of age.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culturally Grounded Intervention; One week of meetings to describe Blackfeet history, culture, traditions, and cerimonies. One additional week of visiting Blackfeet sacred sites.	Behavioral: Culturally Grounded Intervention; Education to increase awareness of Blackfeet culture and connectedness to Blackfeet community

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rheumatoid Arthritis Disease Activity	Arthritis activity will be determined bu clinical assessments and self-reported symptom severity.	Outcomes will be determined just before the intervention (day 1), just after intervention (day 14) and 6 months later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Inflammation	Systemic inflammation determined by assessing blood levels of inflammation biomarkers CRP, IL-6 and IL-17.	Systemic inflammation determined immediately before intervention (day 1), immediately after end of intervention 9Day 14), and 6 months after intervention.

Collaborators and Investigators

• Sponsor: Blackfeet Community College
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 1674119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No