Culturally Adapted Pain Management for Indigenous Peoples

NCT07524751 | Recruiting

• 1 other identifier: 4R00MD017254
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study involves a randomized feasibility pilot trial of a culturally adapted psychological intervention for chronic pain for American Indian/Alaska Native (AI/AN) 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (3)

• Treatment adherence

  From the start of treatment to the end of treatment at 7 weeks.

• Treatment satisfaction

  Post-treatment assessment, conducted after completion of the 7 weeks of treatment.

• Cultural congruency

  Post-treatment assessment, conducted after completion of the 7 weeks of treatment.

Study Arms (2)

Active Treatment

EXPERIMENTAL

Treatment is group-based and remote-based. Treatment groups will include 4-6 study participants. A total of 7 treatment sessions are delivered on a weekly basis. The treatment is an integration of evidence-based psychological tools for pain management and Indigenous healing practices.

Behavioral: Braided Skills for Managing Pain

Treatment-as-usual

NO INTERVENTION

Study participants will proceed with their medical care as usual for chronic pain.

Interventions

Braided Skills for Managing Pain BEHAVIORAL

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).

Active Treatment

Eligibility Criteria

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

You may qualify if:

• at least 18 years of age
• identify as AI/AN (or by another preferred name, such Native American, Native, and/or Indigenous)
• have at least one diagnosis consistent with chronic pain and/or 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

You may not qualify if:

• 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/or substance abuse

Sponsors & Collaborators

• University of California, San Diego: lead
• Porland Area Indian Health Services - Yakama Service Unit: collaborator

Study Sites (1)

Portland Area Indian Health Services - Yakama Service Unit

Yakima, Washington, 98948, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Andrea K Newman, PhD

CONTACT

253-271-4289; a7newman@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: A total of 30 study participants will be randomized to either active treatment or treatment-as-usual (i.e., continued medical care for chronic pain).

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: April 13, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (1)