Chronic PainNCT06725329
Developing a Tailored Psychosocial Education Intervention for Chronic Pain Management for Asian Americans
A study testing A tailored psychosocial education intervention in people with Chronic Pain, run by George Washington University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- A tailored psychosocial education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2025to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
George Washington University School of Nursing
Ashburn, Virginia, 20147
The George washington University
Washington D.C., District of Columbia, 20006
About this study
Official title: Developing a Tailored Psychosocial Education Intervention for Chronic Pain Management for Asian Americans in the Community
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.
Read the detailed description
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.
- Conditions
- Chronic Pain
- Being tested
- A tailored psychosocial education intervention
- 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
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A tailored psychosocial education interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: A tailored psychosocial education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Within 2 weeks upon the completion of the final session(10-12 Week)
Secondary outcomes (3)
Health status (Physical/mental well-being)
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.
Measured: From Enrollment (T1), Week 10 (T2), Week 22 (T3)
Acculturation
Acculturation will be measured using the Short Acculturation Scale, which includes 12 items focusing on language use, media use, and ethnic social relations
Measured: Enrollment (T1)
Social Isolation
Social Network will be assessed by using the Lubben Social Network Scale to measure contacts, talks, and supports from family and friends networks.
Measured: Enrollment (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start8 Mar 2025
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Hee Jun Kim, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725329
- Sponsor's protocol ID
- NCR235347
- Other IDs
- 1R21NR021224-01
- Status last verified
- Mar 2026
- First submitted
- 15 Nov 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team has not decided whether the IPD will or not be shared. The research team will discuss this matter after the trial is completed.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Tailored Psychosocial Education Intervention for Chronic Pain Management for Asian Americans in the Community
- ClinicalTrials.gov ID
- NCT06725329
- Acronym / sponsor ID
- NCR235347
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Adapted and culturally-integrated psychosocial education intervention | Experimental | Behavioral: A tailored psychosocial education interventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A tailored psychosocial education interventionParticipants 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. | Behavioural | Adapted and culturally-integrated psychosocial education intervention |
Primary outcome
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.
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.
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).
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.
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).
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.
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.
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).
3 secondary outcomes
Health status (Physical/mental well-being)
Time frame: From Enrollment (T1), Week 10 (T2), Week 22 (T3)
Acculturation
Time frame: Enrollment (T1)
Social Isolation
Time frame: Enrollment (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided. The research team has not decided whether the IPD will or not be shared. The research team will discuss this matter after the trial is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A tailored psychosocial education intervention in people with Chronic Pain, run by George Washington University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility_Recruitment/retention (time frame: From T1 (enrollment) to T2 (at completion of the 10 week session)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.