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| Name | Class |
|---|---|
| Porland Area Indian Health Services - Yakama Service Unit | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | 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. |
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| Treatment-as-usual | No Intervention | Study participants will proceed with their medical care as usual for chronic pain. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Successful recruitment is defined by the randomization of 30 study participants | Until the end of the recruitment phase (once all study participants have been recruited, an estimated 1-2 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence | Treatment adherence will be successful if the average treatment adherence rate is at least 70% | From the start of treatment to the end of treatment at 7 weeks. |
| Treatment satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea K Newman, PhD | Contact | 253-271-4289 | a7newman@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portland Area Indian Health Services - Yakama Service Unit | Recruiting | Yakima | Washington | 98948 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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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).
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Treatment will be considered satisfactory if the mean on the Patient Global Assessment of Treatment Satisfaction questionnaire is 3 and above.
| Post-treatment assessment, conducted after completion of the 7 weeks of treatment. |
| Cultural congruency | Cultural congruency of treatment will be considered successful if qualitative interviews suggest themes of cultural congruency | Post-treatment assessment, conducted after completion of the 7 weeks of treatment. |