Developing a Tailored Psychosocial Education Intervention for Chronic Pain Management for Asian Americans in the Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Feasibility_Recruitment/retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: A tailored psychosocial education intervention (Behavioral)
结局指标
主要结局
Feasibility_Recruitment/retention
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Health status (Physical/mental well-being)(From Enrollment (T1), Week 10 (T2), Week 22 (T3))
- Acculturation(Enrollment (T1))
- Social Isolation(Enrollment (T1))
研究者
Hee Jun Kim
Associate Professor
George Washington University