Trauma-Informed Intervention for Rheumatoid Arthritis on Blackfeet Nation

NCT06472544 | Not Yet Recruiting

• 1 other identifier: 1674119
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Systemic Inflammation

  Systemic inflammation determined immediately before intervention (day 1), immediately after end of intervention 9Day 14), and 6 months after intervention.

Study Arms (1)

Culturally Grounded Intervention

EXPERIMENTAL

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

Behavioral: Culturally Grounded Intervention

Interventions

Culturally Grounded Intervention BEHAVIORAL

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

Culturally Grounded Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self reported Blackfeet heritage. -

Sponsors & Collaborators

• Blackfeet Community College: lead
• University of Washington: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Betty Matthews

CONTACT

14068454583; b_mathews@bfcc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As there is only one group which the intervention group there is no need for masking as to treatment type.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share