Culturally Adapted Pain Management for Indigenous Peoples

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Recruitment [Срок оценки: Until the end of the recruitment phase (once all study participants have been recruited, an estimated 1-2 years).]

Вторичные конечные точки (3)

• Treatment adherence [Срок оценки: From the start of treatment to the end of treatment at 7 weeks.]
• Treatment satisfaction [Срок оценки: Post-treatment assessment, conducted after completion of the 7 weeks of treatment.]
• Cultural congruency [Срок оценки: Post-treatment assessment, conducted after completion of the 7 weeks of treatment.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Portland Area Indian Health Services - Yakama Service Unit — Yakima

Идентификаторы

NCT: NCT07524751 · 4R00MD017254

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗