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（由申请人提供）：慢性疼痛对于 HIV 感染者/艾滋病患者 (PLWHA) 来说是一个严重的问题，尽管治疗疼痛的药物选择通常有限，但 30% 至 65% 接受 HIV 护理的患者的疼痛会影响日常活动。部分有效，但针对旨在解决艾滋病毒感染者功能（或其他疼痛结果）的疼痛干扰的非药物治疗的研究很少。艾滋病毒感染者的疼痛治疗因抑郁症等合并症而变得更加复杂。慢性疼痛和抑郁症状（在感染者中非常普遍）的同时出现与单独出现任何一个问题相关的痛苦和残疾增加相关。感染者通常在初级保健机构接受护理，随着复杂慢性病患者“医疗之家”的发展，针对身体疼痛和抑郁的协调初级保健治疗可能是长期艾滋病毒护理的良好模式。在国家护理研究所为期 2 年的资助下，我们开发了一种协作性社会心理辅助治疗方法，用于控制初级保健中感染者的疼痛和抑郁，这项干预措施名为 HIV-PASS（艾滋病毒疼痛和悲伤研究）， HIV-PASS 整合并建立在针对慢性疼痛和抑郁的行为疗法之上，其目标是教会患者减少行为回避和增加日常有价值活动参与的技能，从而最终提高功能能力（即心理社会能力）。 HIV-PASS 并不直接治疗药物滥用/滥用，而是根据需要明确支持药物滥用治疗。在这项初步工作中，我们对 HIV-PASS 与药物滥用进行了随机对照试验 (n = 23)。针对患有慢性疼痛和抑郁症状加重的感染者的健康教育 (HE) 对照组，我们确定了几个指标的可行性和可接受性，包括患者对治疗方案的依从性，并发现在当前的 R01 应用中，组间的结果存在重要差异。建议进行充分的在慢性疼痛和抑郁症状加重的感染者中进行 HIV-PASS 与 HE 的有力随机对照试验 我们将招募 236 名患者，提供超过 3 个月的干预措施，并对患者进行总共 12 个月的随访，以便我们进行短期观察。我们计划比较 HIV-PASS 与 HE 的以下方面：1) 主要结果变量，在 3 个月的急性治疗阶段对身体和心理功能的干扰（“疼痛干扰”）；2) 次要结果；变量急性治疗阶段，包括抑郁、焦虑、体力活动（每天步数，用加速度计测量）、抗逆转录病毒治疗依从性和病毒载量；3) 12 个月内的主要和次要结果变量（即急性治疗阶段 + 后续治疗） 4) 我们还将研究 HIV-PASS 减少疼痛干扰的机制。