Culturally Adapted Pain Management for Indigenous Peoples in the Pacific Northwest (CAP-I)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment-as-usual
Study participants will proceed with their medical care as usual for chronic pain.
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.
干预措施: Braided Skills for Managing Pain (Behavioral)
结局指标
主要结局
Recruitment
时间窗: 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
次要结局
- Treatment adherence(From the start of treatment to the end of treatment at 7 weeks.)
- Treatment satisfaction(Post-treatment assessment, conducted after completion of the 7 weeks of treatment.)
- Cultural congruency(Post-treatment assessment, conducted after completion of the 7 weeks of treatment.)
研究者
Andrea K. Newman
Assistant Clinical Professor
University of California, San Diego