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Recruiting NCT07524751

Culturally Adapted Pain Management for Indigenous Peoples

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Braided Skills for Managing Pain.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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, ceremon

Primary outcome measures

  • Recruitment [Time frame: Until the end of the recruitment phase (once all study participants have been recruited, an estimated 1-2 years).]
Secondary outcome measures (3)
  • Treatment adherence [Time frame: From the start of treatment to the end of treatment at 7 weeks.]
  • Treatment satisfaction [Time frame: Post-treatment assessment, conducted after completion of the 7 weeks of treatment.]
  • Cultural congruency [Time frame: Post-treatment assessment, conducted after completion of the 7 weeks of treatment.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Portland Area Indian Health Services - Yakama Service Unit — Yakima

Identifiers

NCT: NCT07524751 · 4R00MD017254

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗