Culturally Adapted Pain Management for Indigenous Peoples
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Braided Skills for Managing Pain
BehavioralThe 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).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active TreatmentExperimental treatment 1 intervention
Group B: Treatment-as-usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment
Successful recruitment is defined by the randomization of 30 study participants
Time frame
Until the end of the recruitment phase (once all study participants have been recruited, an estimated 1-2 years).Secondary outcomes
1
Treatment adherence
Treatment adherence will be successful if the average treatment adherence rate is at least 70%
Time frame
From the start of treatment to the end of treatment at 7 weeks.2
Treatment satisfaction
Treatment will be considered satisfactory if the mean on the Patient Global Assessment of Treatment Satisfaction questionnaire is 3 and above.
Time frame
Post-treatment assessment, conducted after completion of the 7 weeks of treatment.3
Cultural congruency
Cultural congruency of treatment will be considered successful if qualitative interviews suggest themes of cultural congruency
Time frame
Post-treatment assessment, conducted after completion of the 7 weeks of treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
Porland Area Indian Health Services - Yakama Service Unit
Collaborator
Source ClinicalTrials.gov