Proof of concept study to treat negative affect in chronic low back pain

治疗慢性腰痛负面影响的概念验证研究

• 批准号: 10258046
• 负责人: AJAY D WASAN
• 金额: $ 12.99万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258046
• 关键词: Address; Adult; American; Antidepressive Agents; Anxiety; Anxiety Disorders; Behavior Therapy; Behavioral; Biological; Blinded; Caring; Chronic low back pain; Clinical; Collaborations; Combined Modality Therapy; Community Practice; Country; Data; Data Management Resources; Development; Dose; Dose-Rate; Education; Enrollment; Environment; Evidence based treatment; Fright; Future; Goals; Impairment; Institutional Review Boards; Intervention; Logistic Regressions; Major Depressive Disorder; Measures; Mediating; Mental Depression; Mental Health; Mental disorders; Methods; Mission; Mood Disorders; Motivation; Occupational Therapist; Opioid; Outcome; Pain; Pain Research; Pain interference; Pain management; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Phenotype; Physical therapy; Physicians; Prediction of Response to Therapy; Protocols documentation; Randomized; Refractory; Rehabilitation therapy; Retreatment; Self Medication; Services; Site; Statistical Data Interpretation; Subgroup; Testing; Training; anxious; arm; avoidance behavior; base; chronic pain; comorbid depression; comorbidity; compare effectiveness; conditioned pain modulation; craving; depressive symptoms; design; disability; drug misuse; effective therapy; evidence base; fitness; improved; improved outcome; interest; mobile application; multi-component intervention; multimodality; negative affect; non-opioid analgesic; novel; opioid epidemic; opioid misuse; opioid use; pain catastrophizing; pain patient; patient subsets; physical therapist; predicting response; predictive modeling; prescription opioid; prevent; primary endpoint; primary outcome; psychological symptom; randomized trial; recruit; responders and non-responders; response; secondary endpoint; secondary outcome; side effect; sleep quality; suicidal risk; symptom cluster; therapeutic target; treatment as usual; treatment group; treatment response

Modified Project Summary/Abstract Section This proposal responds to NOT-OD-20-101 to address the need to effectively reduce stigma related to the treatment of chronic pain in the context of the opioid crisis. Patients with chronic low back pain (CLBP) frequently have high levels of depressive and anxiety symptoms, termed “high negative affect (NA)”, and are often treated with opioid therapy. Chronic pain, mental health, and opioid use are all associated with stigma, the devaluation of a person due to the person exhibiting certain characteristics. Stigma, across these domains, is associated with decreased treatment seeking, poor treatment adherence, increased depression, greater pain, and overall worse treatment outcomes. However, these types of stigma do not operate in silos. Instead the intersectionality of health-related stigma (IHRS) may have synergistic effects. However, no studies to date examine IHRS in relation to chronic pain, opioid use, and mental health. Moreover, there is a need to develop evidence-based interventions to reduce pain and opioid related stigma that can be widely implemented. The present project will capitalize on the comparative effectiveness trial of antidepressant medication, Enhanced Fear Avoidance Rehabilitation (EFAR), or their combination in 300 patients with chronic low back pain and high negative affect. In this proposal we will examine IHRS as a potential treatment moderator and determine the preliminary efficacy of EFAR to reduce pain, opioid, and mental health stigma. Moreover, we will collect qualitative data from participants in the trial that will inform the further development of a stigma reducing intervention that can be implemented by physical and occupational therapists. This mixed-method approach will not only extend the study of intersectional stigma to the domains of chronic pain, opioid use, and mental health, but will allow us to better understand the needs of this patient population. Gathering qualitative data will help us move from Stage 0 to Stage 1 intervention development, allowing for timely intervention refinement and implementation. In sum, these findings may have implications for the development and refinement of a stigma-reducing intervention that can be widely implemented across disciplines thereby improving access and effectiveness of chronic pain and opioid use prevention, management, and treatment strategies.

修改后的项目摘要/摘要部分 这项提案回应了NOT-OD-20-101，以解决在阿片类药物危机背景下有效减少与慢性疼痛治疗有关的耻辱的需要。慢性下腰痛(CLBP)患者通常有高度的抑郁和焦虑症状，被称为“高度负面影响(NA)”，并经常接受阿片类药物治疗。慢性疼痛、心理健康和阿片类药物的使用都与污名有关，污名是指一个人因表现出某些特征而贬值。在这些领域，耻辱与寻求治疗的减少、治疗依从性差、抑郁增加、更大的疼痛和总体上更差的治疗结果有关。然而，这些类型的柱头在筒仓中不起作用。相反，与健康相关的耻辱(IHRS)的交叉性可能具有协同效应。然而，到目前为止，还没有研究IHRS与慢性疼痛、阿片类药物使用和心理健康的关系。此外，有必要制定循证干预措施，以减少与疼痛和阿片类药物相关的耻辱，并可广泛实施。本项目将利用300名患有慢性下腰痛和高度负面情绪的患者进行的抗抑郁药物、增强恐惧回避康复(EFAR)或其组合的比较有效性试验。在这项提案中，我们将研究IHRS作为一种潜在的治疗调节剂，并确定EFAR在减少疼痛、阿片类药物和精神健康污名方面的初步疗效。此外，我们将从试验参与者那里收集定性数据，这些数据将为进一步发展物理和职业治疗师可以实施的减少耻辱的干预措施提供信息。这种混合方法不仅将对跨部门污名的研究扩展到慢性疼痛、阿片类药物使用和心理健康领域，而且将使我们能够更好地了解这些患者群体的需求。收集定性数据将帮助我们从阶段0进入阶段1干预开发，以便及时改进和实施干预措施。总之，这些发现可能对发展和完善可跨学科广泛实施的减少耻辱的干预措施产生影响，从而改善慢性疼痛和阿片类药物使用的预防、管理和治疗战略的可及性和有效性。