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NCT Number: NCT07524751

Culturally Adapted Pain Management for Indigenous Peoples

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portland Area Indian Health Services - Yakama Service Unit

Yakima, Washington, 98948, United States

Location status: Recruiting

Location contact

Ryan Pett, PharmD, MPH, BCPS

CONTACT

[email protected]

509-865-1728

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Recruitment

    Time frame: Until the end of the recruitment phase (once all study participants have been recruited, an estimated 1-2 years).

    Successful recruitment is defined by the randomization of 30 study participants

Secondary outcomes

  1. Treatment adherence

    Time frame: From the start of treatment to the end of treatment at 7 weeks.

    Treatment adherence will be successful if the average treatment adherence rate is at least 70%

  2. Treatment satisfaction

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

    Treatment will be considered satisfactory if the mean on the Patient Global Assessment of Treatment Satisfaction questionnaire is 3 and above.

  3. Cultural congruency

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

    Cultural congruency of treatment will be considered successful if qualitative interviews suggest themes of cultural congruency

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea K Newman, PhD

CONTACT

[email protected]

253-271-4289

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Porland Area Indian Health Services - Yakama Service Unit

Registry information

Official study title

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

Acronym: CAP-I

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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