Chronic Pain
Conditions
Brief summary
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
BEHAVIORALBraided 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).
Sponsors
University of California, San Diego
Porland Area Indian Health Services - Yakama Service Unit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment adherence | From the start of treatment to the end of treatment at 7 weeks. | Treatment adherence will be successful if the average treatment adherence rate is at least 70% |
| Treatment satisfaction | Post-treatment assessment, conducted after completion of the 7 weeks of treatment. | Treatment will be considered satisfactory if the mean on the Patient Global Assessment of Treatment Satisfaction questionnaire is 3 and above. |
| Cultural congruency | Post-treatment assessment, conducted after completion of the 7 weeks of treatment. | Cultural congruency of treatment will be considered successful if qualitative interviews suggest themes of cultural congruency |
Countries
United States
Contacts
CONTACTAndrea K Newman, PhD
Outcome results
None listed