Trauma-Informed Intervention for Rheumatoid Arthritis on Blackfeet Nation

NCT ID: NCT06472544

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-09-01

Brief Summary

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.

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Culturally Grounded Intervention

One week of meetings to describe Blackfeet history, culture, traditions, and cerimonies. One additional week of visiting Blackfeet sacred sites.

Group Type: EXPERIMENTAL

Culturally Grounded Intervention

Intervention Type: BEHAVIORAL

Education to increase awareness of Blackfeet culture and connectedness to Blackfeet community

Interventions

Culturally Grounded Intervention

Education to increase awareness of Blackfeet culture and connectedness to Blackfeet community

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Self reported Blackfeet heritage. -

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Blackfeet Community College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Betty Matthews

Role: CONTACT

b_mathews@bfcc.edu

14068454583

Other Identifiers

1674119

Identifier Type: -

Identifier Source: org_study_id