Developing a Tailored Psychosocial Education Intervention for Chronic Pain Management for Asian Americans

NCT06725329 | Completed

• 2 other identifiers: NCR2353471R21NR021224-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic pain is a major population health issue affecting more than 100 million Americans and variations in chronic pain experiences have been widely documented, including differences in pain burden and likelihood of undertreatment. Evidence regarding chronic pain experiences of Asian Americans is limited, as are resources and evidence-based programs for this group. Our exploratory, developmental study will provide evidence of feasibility and acceptability of a tailored psychosocial education intervention to reduce pain catastrophizing and improve pain outcomes for Asian Americans.

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

Outcome Measures

Primary Outcomes (8)

• Feasibility_Recruitment/retention

  Recruitment rates will be monitored over the recruitment periods, and reasons for non-consent will be recorded. Retention will be monitored across T1 to T2, and if participants withdraw during the study periods, they will be asked for reasons and invited to the post-intervention interviews to elaborate on their choice to withdraw.

  From T1 (enrollment) to T2 (at completion of the 10 week session)

• Pain Outcomes_Pain Catastrophizing

  Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS), a 13-item scale that assesses catastrophic thinking, including subscales of helplessness, rumination, and magnification, in response to pain. The PCS total score will be calculated by summing the total item responses; higher scores on the PCS are indicative of greater pain-related catastrophizing.

  T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)

• Pain Outcomes_Pain Interference

  Pain interference will be also measured using the BPI-SF subscale. The subscale evaluates the degree of interference with general activity, mood, walking, work, sleep, relations with using a numeric rating scale (0 = 'no interference' and 10 = 'interferes completely).

  T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)

• Pain Outcomes_Pain Intensity

  Pain intensity will be measured using the 4-item Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity subscale, which uses an 11-point numeric rating scale (0 = 'no pain' and 10 = 'pain as bad as you can imagine') to evaluate pain at its worst, least, average, and current severity over the past week.

  T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)

• Feasibility_Participant engagement

  Participant engagement will be tested by the number of completed sessions, including completion of weekly activities (i.e., coping strategies).

  4 Week, 8 Week, T2(10 Week)

• Feasibility_Participant satisfaction

  Participant satisfaction will be measured by one item asking, "Overall, how satisfied were you with the 10 -week pain management program?" The item will be rated on a 7-point Likert scale from very dissatisfied to very satisfied.

  4 Week, 8 Week, T2(10 Week)

• Feasibility_Barriers/facilitators to engagement

  Individual, semi-structured in-depth interviews will be conducted within 2 weeks upon the completion of the final session to obtain participants' reflections of and feedback on the program.

  Within 2 weeks upon the completion of the final session(10-12 Week)

• Acceptability_Perceived appropriateness

  Individual, semi-structured in-depth interviews will be conducted within 2 weeks upon the completion of the final session to obtain participants' reflections of and feedback on the program. Acceptability is defined as the perception that a new intervention is agreeable or satisfactory. Perceived appropriateness for the intervention format, the lengths of the group session, and the total intervention program will be assessed using semi-structured interviews with subset of study participants (n = 10).

  Within 2 weeks upon the completion of the final session(10-12 Week)

Secondary Outcomes (3)

• Health status (Physical/mental well-being)

  From Enrollment (T1), Week 10 (T2), Week 22 (T3)

• Acculturation

  Enrollment (T1)

• Social Isolation

  Enrollment (T1)

Study Arms (1)

Adapted and culturally-integrated psychosocial education intervention

EXPERIMENTAL

Participants will receive the culturally adapted psychosocial educational program for chronic pain management. The investigators will adapt the Learn About My Pain (LAMP) program that has previously been established for efficacy in reducing chronic pain intensity, pain interference, and pain catastrophizing in racialized groups in community settings. The LAMP intervention provides biopsychosocial education sessions about chronic pain and its management.

Behavioral: A tailored psychosocial education intervention

Interventions

A tailored psychosocial education intervention BEHAVIORAL

Participants will get ten 60-minute psychoeducational group sessions about chronic pain and its management. The group sessions will be conducted by the PI and a bilingual project director at Korean churches or daycare centers in Baltimore-Washington Metropolitan area. The psychoeducational group session will be adapted from LAMP intervention that has been previously developed. The intervention provides biopsychosocial education sessions about chronic pain and its management. For example, sessions focus on providing information regarding: (1) pain and the biological stress response and the gate control theory of pain, (2) the psychological impact of thoughts and emotions on pain and (3) facilitated group discussions to help participants develop a new understanding of pain through shared social experiences, all of which have been shown to improve pain outcomes.

Adapted and culturally-integrated psychosocial education intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• George Washington University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

The George washington University

Washington D.C., District of Columbia, 20006, United States

Location

George Washington University School of Nursing

Ashburn, Virginia, 20147, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 10, 2024
• Study Start: March 8, 2025
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (2)