Improving Functioning in HIV Patients with Chronic Pain and Comorbid Depressive Symptoms

改善患有慢性疼痛和共存抑郁症状的艾滋病毒患者的功能

• 批准号: 9253445
• 负责人: Michael D Stein
• 金额: $ 46.13万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9253445
• 关键词: AIDS/HIV problem; Accelerometer; Activities of Daily Living; Acute; Address; Adherence; Anti-Retroviral Agents; Anxiety; Behavior Therapy; Behavioral; Caring; Chronic Disease; Collaborations; Comorbidity; Complex; Control Groups; Data; Depressed mood; Effectiveness; Enrollment; Exercise; Funding; Goals; Grant; Growth; HIV; Health education; Healthcare; Home environment; Household; Individual; Intervention; Joints; Measures; Mediator of activation protein; Medical; Mental Depression; Mental Health; Modeling; Movement; National Institute of Nursing Research; Nurses; Outcome; Pain; Pain Clinics; Pain interference; Pain management; Participant; Patients; Perception; Persons; Pharmacological Treatment; Pharmacology; Phase; Phonation; Physical Function; Physical activity; Population; Primary Health Care; Provider; Psychologist; Quality of life; Randomized Controlled Trials; Research; Risk; Social Workers; Telephone; Testing; Treatment Protocols; Treatment outcome; Viral Load result; Walking; Work; arm; base; behavioral health; behavioral study; chronic depression; chronic pain; comorbid depression; compliance behavior; cost effective; cost effectiveness; depressive symptoms; disability; experience; follow-up; health related quality of life; improved; improved functioning; meetings; pain symptom; primary care setting; primary outcome; psychologic; psychosocial; public health relevance; randomized trial; secondary outcome; skills; social; substance abuse treatment; substance misuse; theories; therapy design; treatment planning

 DESCRIPTION (provided by applicant): Chronic pain is a significant problem for persons living with HIV/AIDS (PLWHAs). Thirty to 65% of patients receiving HIV care have pain that interferes with daily activities. Although pharmacological options to treat pain are often only partially effective, there is little research on non-pharmacological treatments designed to address pain interference with functioning (or other pain outcomes) in PLWHAs. Pain treatment in PLWHAs is further complicated by comorbidities such as depression and substance misuse/ abuse. The co-occurrence of chronic pain and depressive symptoms (highly prevalent among PLWHAs) is associated with increased suffering and disability relative to either problem alone. Both chronic pain and depression increase the risk of non-adherence to antiretroviral treatment. PLWHAs often receive care in primary care settings, and with the growth of the "medical home" for patients with complex chronic illnesses, the coordinated primary care treatment of physical pain and depression may be a good model for long-term HIV care. Funded by a 2-year grant from the National Institute of Nursing Research, we developed a collaborative, psychosocial adjunctive treatment for managing both pain and depression in PLWHAs in primary care. This intervention, entitled HIV-PASS (HIV Pain and Sadness Study), integrates and builds upon behavior therapy for chronic pain and depression. The goal of HIV-PASS is to teach patients skills for reducing behavioral avoidance and increasing engagement in day-to- day valued activities, thereby ultimately improving functional capacity (i.e., both psychosocial and physical functioning) and decreasing depression. HIV-PASS does not directly treat substance misuse/ abuse but involves explicit support for substance abuse treatment as needed. In this preliminary work, we conducted an RCT (n = 23) of HIV-PASS vs. a health education (HE) control group for PLWHAs with chronic pain and elevated depressive symptoms. We established feasibility and acceptability on several metrics, including patient adherence to the treatment protocol and found important between group differences in outcomes. In the current R01 application, we propose to conduct an adequately powered randomized controlled trial of HIV- PASS vs. HE in PLWHAs with chronic pain and elevated depressive symptoms. We will enroll 236 patients, provide interventions over 3 months, and follow patients for a total of 12 months so that we may observe short- term and longer-term effects. We plan to compare HIV-PASS to HE on: 1) the primary outcome variable, interference with physical and psychosocial functioning ("pain interference"), over the 3-month acute treatment phase; 2) secondary outcome variables in the acute treatment phase, including depression, anxiety, physical activity (steps per day, measured with accelerometers), antiretroviral adherence, and viral load; 3) primary and secondary outcome variables over 12 months (i.e., acute treatment phase + a follow-up phase); and 4) cost effectiveness. We will also examine mechanisms by which HIV-PASS may reduce pain interference.

 描述（适用提供）：对于患有艾滋病毒/艾滋病（PLWHAS）的人来说，慢性疼痛是一个重大问题。 30％至65％的接受HIV护理的患者患有疼痛，会干扰日常活动。尽管治疗疼痛的药理学选择通常仅是部分有效的，但对于旨在解决PLWHAS中功能（或其他疼痛结果）的疼痛干扰的非药物治疗的研究很少。抑郁症和药物滥用/滥用等合并症，PLWHAS中的疼痛治疗更加复杂。慢性疼痛和抑郁症状的同时出现（在PLWHAS中高度普遍）与仅相对于任何一个问题而增加的苦难和残疾。慢性疼痛和抑郁症都会增加对抗逆转录病毒治疗的不遵守风险。 PLWHAS经常在初级保健环境中获得护理，并且随着“医疗之家”对患有复杂慢性疾病的患者的增长，对身体疼痛和抑郁症的协调初级保健治疗可能是长期HIV护理的好模型。由美国国家护理研究所（National Institute of Nation）护理研究所（National Institute of Native of Naturaling Research）提供了2年的赠款，我们开发了一种协作，心理社会辅助治疗，用于管理初级保健中PLWHA的疼痛和抑郁症。这种干预措施为艾滋病毒 - 帕斯（HIV）疼痛和悲伤研究，是基于慢性疼痛和抑郁症的行为疗法的融合和基础。艾滋病毒 - 帕斯（HIV-PASS）的目的是教患者技能，以减少避免行为的避免行为并增加日常有价值的活动的参与度，从而最终提高功能能力（即心理社会和身体功能）并减少抑郁症。 HIV - 帕斯不会直接治疗物质/滥用物质，而是根据需要明确支持药物滥用治疗。在这项初步工作中，我们进行了艾滋病毒 - 帕斯（N = 23）的RCT（n = 23），与患有慢性疼痛和抑郁症状升高的PLWH的健康教育（HE）对照组。我们在几个指标上建立了可行性和可接受性，包括患者遵守治疗方案，发现群体差异之间的重要性很重要。在当前的R01应用中，我们建议对HIV-PASS进行足够动力的随机对照试验，而在PLWHA中，患有慢性疼痛和抑郁症状升高。我们将招募236名患者，在3个月内提供干预措施，并关注患者总共12个月，以便我们可以观察到短期和长期影响。我们计划将HIV通路与HE进行比较：1）在3个月的急性治疗阶段，主要结果变量，干扰了身体和社会心理功能（“疼痛干扰”）； 2）急性治疗阶段中的次要结局变量，包括抑郁，焦虑，体育活动（每天的步骤，用加速度计测量），抗逆转录病毒依从性和病毒载荷； 3）在12个月内（即急性治疗阶段 +随访阶段）的初级和次要结果变量； 4）成本效益。我们还将检查HIV-PASS可以减轻疼痛干扰的机制。