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Completed

NCT Number: NCT06725329

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The George washington University, Washington D.C., District of Columbia, United States

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About this study

Variances in chronic pain experience exists in the US, including between-person differences in pain burden and likelihood of undertreatment. Asian Americans (AA) are most likely to be limited in English proficiency, which may contribute to their linguistic and social isolation. Underdiagnosis and underreporting of pain among AA have been reported. AA may discourage reporting their pain to avoid burdening others or being seen as weak. Rather than seeking medical assistance, AA have been reported to tend to accept the pain as natural or to suffer to maintain their independence. Our preliminary studies found that Korean Americans (KA) exhibited higher levels of pain severity and pain catastrophizing compared to their counterparts living in Korea. However, very few evidence-based programs are available that can be implemented for this linguistically/socially isolated group. This proposed study aims to fill critical knowledge gaps in pain research by providing evidence of feasibility and acceptability of a tailored psychosocial pain education intervention for AA using the KA as an exemplar. Using a sequential exploratory mixed-method design incorporating a Community-Based Participatory Research approach, we will: (1) iteratively adapt and integrate a previously established psychosocial education intervention for KA to develop an effective program to improve pain outcomes for understudied KA with chronic pain in the community; conduct KA Community Advisory Board meetings and participant focus group interviews to improve the intervention design and content, and (2) evaluate the feasibility and acceptability of the adapted psychosocial education intervention using a single group, pre-posttest design with 30 foreign-born KA with chronic pain. We will conduct a survey to assess improvements in the outcomes (i.e., pain catastrophizing, pain intensity/interference) at 3 time points (pre-test, post-test, 12 weeks after the intervention). Post-intervention in-depth interviews will be conducted with subset of the participants (n = 10) on their reflections about the program. Feasibility and acceptability will be evaluated by integrating quantitative (i.e., recruitment/retention rate, participants engagement) and qualitative (i.e., perceived appropriateness) findings. Achievement of study goals will demonstrate for the first time that a nurse-led, community-based psychosocial education intervention to reduce chronic pain may be feasible and acceptable, forming the basis for a larger efficacy trial to test the tailored intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility_Recruitment/retention

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

    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.

  2. Pain Outcomes_Pain Catastrophizing

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

    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.

  3. Pain Outcomes_Pain Interference

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

    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).

  4. Pain Outcomes_Pain Intensity

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

    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.

  5. Feasibility_Participant engagement

    Time frame: 4 Week, 8 Week, T2(10 Week)

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

  6. Feasibility_Participant satisfaction

    Time frame: 4 Week, 8 Week, T2(10 Week)

    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.

  7. Feasibility_Barriers/facilitators to engagement

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

    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.

  8. Acceptability_Perceived appropriateness

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

    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).

Secondary outcomes

  1. Health status (Physical/mental well-being)

    Time frame: From Enrollment (T1), Week 10 (T2), Week 22 (T3)

    Health status will be measured using the Short Form (SF)-12 to capture physical and mental well-being and limitations. The SF-12 score is a measure of both physical and mental well-being, with a higher score indicating better overall health, where scores are typically interpreted with a range of 0-100, with a score above 50 generally considered to be within a healthy range for both physical and mental components; the SF-12 calculates separate "Physical Component Summary (PCS)" and "Mental Component Summary (MCS)" scores based on responses to 12 questions covering different aspects of health like physical functioning, bodily pain, vitality, and mental health.

    The SF-12 assesses eight health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The Korean version of the SF-12 v2 that has been previously validated will be used for this study.

  2. Acculturation

    Time frame: Enrollment (T1)

    Acculturation will be measured using the Short Acculturation Scale, which includes 12 items focusing on language use, media use, and ethnic social relations

  3. Social Isolation

    Time frame: Enrollment (T1)

    Social Network will be assessed by using the Lubben Social Network Scale to measure contacts, talks, and supports from family and friends networks.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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