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

基本信息

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
项目类别：
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

项目摘要

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/摘要部分该提案响应 NOT-OD-20-101，旨在解决在阿片类药物危机背景下有效减少与慢性疼痛治疗相关的耻辱的需要。慢性腰痛 (CLBP) 患者经常患有严重的抑郁症和抑郁症。焦虑症状，称为“高负面影响（NA）”，通常用阿片类药物治疗，慢性疼痛、心理健康和阿片类药物的使用都与耻辱有关，即由于一个人表现出某些特征而导致的贬低。，穿过这些领域与寻求治疗的减少、治疗依从性差、抑郁增加、疼痛加剧和整体治疗结果较差有关。然而，这些类型的耻辱并不是孤立存在的，而是与健康相关的耻辱（IHRS）相交叉。然而，迄今为止还没有研究检查 IHRS 与慢性疼痛、阿片类药物使用和心理健康之间的关系，此外，需要制定可广泛实施的基于证据的干预措施，以减少疼痛和阿片类药物相关的耻辱。本项目将利用在 300 名患有慢性腰痛和高负面影响的患者中进行抗抑郁药物、增强恐惧避免康复 (EFAR) 或其组合的比较有效性试验。在本提案中，我们将检查 IHRS 作为潜在的治疗调节因素，并确定 EFAR 的初步疗效。此外，我们将从试验参与者那里收集定性数据，为进一步开发可以由物理治疗师和职业治疗师实施的减少耻辱的干预措施提供信息。方法不仅会将交叉耻辱的研究扩展到慢性疼痛、阿片类药物使用和心理健康领域，而且使我们能够更好地了解该患者群体的需求，收集定性数据将帮助我们从第 0 阶段转向第 0 阶段。 1 干预措施的制定，以便及时完善和实施干预措施总而言之，这些发现可能对减少耻辱的干预措施的制定和完善产生影响，该干预措施可以跨学科广泛实施，从而改善慢性疼痛和阿片类药物使用预防的可及性和有效性。、管理和治疗策略。