Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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).
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Portland Area Indian Health Services - Yakama Service Unit
Yakima, Washington 98948
Contact:
Ryan Pett, PharmD, MPH, BCPS
509-865-1728
Ryan.Pett@ihs.gov

More Details

Status
Recruiting
Sponsor
University of California, San Diego

Study Contact

Andrea K Newman, PhD
253-271-4289
a7newman@health.ucsd.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.