- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06725329
Developing a Tailored Psychosocial Education Intervention for Chronic Pain Management for Asian Americans
Developing a Tailored Psychosocial Education Intervention for Chronic Pain Management for Asian Americans in the Community
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington D.C., District of Columbia, United States, 20006
- The George Washington University
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Virginia
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Ashburn, Virginia, United States, 20147
- George Washington University School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Adapted and culturally-integrated psychosocial education intervention
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility_Recruitment/retention
Time Frame: From T1 (enrollment) to T2 (at completion of the 10 week session)
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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.
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From T1 (enrollment) to T2 (at completion of the 10 week session)
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Pain Outcomes_Pain Catastrophizing
Time Frame: T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
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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.
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T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
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Pain Outcomes_Pain Interference
Time Frame: T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
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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).
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T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
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Pain Outcomes_Pain Intensity
Time Frame: T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
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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.
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T1 (enrollment), T2 (after the 10 week sessions), and T3(Twelve weeks after the intervention)
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Feasibility_Participant engagement
Time Frame: 4 Week, 8 Week, T2(10 Week)
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Participant engagement will be tested by the number of completed sessions, including completion of weekly activities (i.e., coping strategies).
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4 Week, 8 Week, T2(10 Week)
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Feasibility_Participant satisfaction
Time Frame: 4 Week, 8 Week, T2(10 Week)
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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.
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4 Week, 8 Week, T2(10 Week)
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Feasibility_Barriers/facilitators to engagement
Time Frame: Within 2 weeks upon the completion of the final session(10-12 Week)
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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.
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Within 2 weeks upon the completion of the final session(10-12 Week)
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Acceptability_Perceived appropriateness
Time Frame: Within 2 weeks upon the completion of the final session(10-12 Week)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health status (Physical/mental well-being)
Time Frame: From Enrollment (T1), Week 10 (T2), Week 22 (T3)
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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. |
From Enrollment (T1), Week 10 (T2), Week 22 (T3)
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Acculturation
Time Frame: Enrollment (T1)
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Acculturation will be measured using the Short Acculturation Scale, which includes 12 items focusing on language use, media use, and ethnic social relations
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Enrollment (T1)
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Social Isolation
Time Frame: Enrollment (T1)
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Social Network will be assessed by using the Lubben Social Network Scale to measure contacts, talks, and supports from family and friends networks.
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Enrollment (T1)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCR235347
- 1R21NR021224-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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