Culturally Adapted Pain Management for Indigenous Peoples (CAP-I)

Culturally Adapted Pain Management for Indigenous Peoples in the Pacific Northwest (CAP-I)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Braided Skills for Managing Pain

Detailed Description

The prevalence of chronic pain is higher among American Indian/Alaskan Native (AI/AN) 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/AN 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea K Newman, PhD; Phone Number: 253-271-4289; Email: a7newman@health.ucsd.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment; 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; 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).
No Intervention: Treatment-as-usual; Study participants will proceed with their medical care as usual for chronic pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Cultural congruency	Cultural congruency of treatment will be considered successful if qualitative interviews suggest themes of cultural congruency	Post-treatment assessment, conducted after completion of the 7 weeks of treatment.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Anesthesia and Analgesia; Analgesia
• Other Study ID Numbers: 4R00MD017254 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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