Clinical trial NCT06725329: Reducing Disparities in Chronic Pain Among an Underrepresented Population
Official title: Reducing Disparities in Chronic Pain With a Tailored Psychosocial Education Intervention for an Underrepresented Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: tailored psychosocial education intervention
pain disparity
korean Americans
Asian Americans
Chronic Pain
Learn About My Pain(LAMP) program
Pain intensity
Pain interference
Pain catastrophizing
community-based pain management program
culturally adapted
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2024-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will use a three-phase integrated sequential approach (Qual-Quant-Qual). The first stage is a qualitative phase to adapt and culturally-integrate the psychosocial intervention for KA. Focus group discussions (FGDs) with individuals with lived experience (n = 15) will be conducted in KA. Upon analysis of the FGDs with study participants, the findings will be used to adapt a previously developed psychosocial education intervention for KA (Aim 1). The second phase involves pilot testing the tailored intervention using a single-group, pre-posttest design (n = 30). The last stage will involve post intervention individual, semi-structured in-depth interviews that will focus on participants' reflections of the sessions in relevance to their culture and pain management (n = 10). The feasibility and acceptability of the tailored intervention will be assessed by integrating the qualitative and quantitative findings (Aim 2).
Primary purpose: TREATMENT

Brief summary: Health inequalities in chronic pain exists in the US, with a greater burden of chronic pain and higher rate of misdiagnosis and undertreatment reported in minoritized groups compared to non-Hispanic Whites. Asian Americans (AA) are the fastest-growing racial/ethnic group in the US, yet despite the rapid growth in their numbers, AA remain under-represented in pain disparity research. Cultural norms of Asians may discourage reporting their pain to avoid burdening others or being seen as weak. Rather than seeking medical assistance, Asians have been reported to tend to accept the pain as natural or to suffer to maintain their independence. Very few evidence-based programs are available that can be implemented for this linguistically/socially isolated population in the US. This proposed study aims to fill critical knowledge gaps in pain disparity research by providing evidence of feasibility and acceptability of a culturally-tailored psychosocial pain education intervention for an underrepresented population using the KA community as an exemplar.

Detailed description: Chronic pain is a major population health issue affecting more than 100 million Americans and disparities in chronic pain have been widely documented, indicating minoritized racial and ethnic groups experience a higher burden of chronic pain and are at high risk for undertreatment of that pain. Asian Americans remain underrepresented in pain research; evidence regarding chronic pain experiences of Asian Americans is limited, as are resources and evidence-based programs for this group. This exploratory, developmental study will provide evidence of feasibility and acceptability of a culturally tailored psychosocial education intervention to reduce pain catastrophizing and improve pain outcomes for underrepresented and underserved minority populations.

Eligibility criteria: Inclusion Criteria:

1. Female and male
2. ≥ 18 years old
3. Self-reported foreign born Korean Americans
4. Self-reported pain most days of the month for at least 3 months
5. Pain must be non-malignant, but may have more than one pain source

Exclusion Criteria:

1. Having malignant pain (e.g., cancer or HIV-related)
2. Demonstrating significant cognitive impairment (based on results of a cognitive screener-Short Portable Mental Status Questionnaire)
3. Having current, uncontrolled serious psychological disturbance (e.g., schizophrenia, bipolar disorder) or active substance abuse based on self-report
4. Having low literacy skills in Korean or English (unable to understand the written consent and to sign)
5. Undergoing other psychosocial treatment for pain

   * If excluding a population or group that may benefit from the research, please provide justification: We will exclude children. The original intervention (LAMP) trial has established for efficacy in reducing chronic pain outcomes in adult population. Children are not our target population as we focus on developing a culturally tailored chronic pain management program based on LAMP.

Primary outcomes:
measure: Feasibility_Recruitment/retention
timeFrame: From T1 (enrollment) to T2 (at completion of the 10 week session)
measure: Pain Outcomes_Pain Catastrophizing
timeFrame: T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
measure: Pain Outcomes_Pain Interference
timeFrame: T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
measure: Pain Outcomes_Pain Intensity
timeFrame: T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
measure: Feasibility_Participant engagement
timeFrame: 4 Week, 8 Week, T2(10 Week)
measure: Feasibility_Participant satisfaction
timeFrame: 4 Week, 8 Week, T2(10 Week)
measure: Feasibility_Barriers/facilitators to engagement
timeFrame: Within 2 weeks upon the completion of the final session(10-12 Week)
measure: Acceptability_Perceived appropriateness
timeFrame: Within 2 weeks upon the completion of the final session(10-12 Week)
Secondary outcomes:
measure: Health status (Physical/mental well-being)
timeFrame: From Enrollment (T1), Week 10 (T2), Week 22 (T3)
measure: Acculturation
timeFrame: Enrollment (T1)
measure: Social Isolation
timeFrame: Enrollment (T1)
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George washington University
state: District of Columbia
city: Ashburn
country: United States
facility: George Washington University School of Nursing
state: Virginia
Study officials:
References: