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

 描述(由申请人提供)：慢性疼痛是艾滋病毒/艾滋病患者的一个严重问题。接受艾滋病毒护理的患者中有30%到65%的人疼痛，干扰了日常活动。虽然治疗疼痛的药物选择往往只有部分有效，但针对PLWA中疼痛对功能(或其他疼痛结果)的干扰而设计的非药物治疗方法的研究很少。PLWHA中的疼痛治疗因抑郁和药物滥用/滥用等共病而进一步复杂化。慢性疼痛和抑郁症状的并存(在PLWA中非常普遍)与相对于任何一个问题而增加的痛苦和残疾有关。慢性疼痛和抑郁都会增加不坚持抗逆转录病毒治疗的风险。PLWHA通常在初级保健环境中接受护理，随着复杂慢性病患者的“医疗之家”的增长，协调的初级保健治疗身体疼痛和抑郁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两年的资助下，我们开发了一种协作性的、心理社会的辅助治疗方法，用于在初级保健的PLWHA中管理疼痛和抑郁。这项名为HIV-PASS(艾滋病毒疼痛和悲伤研究)的干预措施整合了慢性疼痛和抑郁的行为疗法，并建立在此基础上。HIV-PASS的目标是教患者减少行为回避的技能，增加对日常有价值活动的参与，从而最终改善功能能力(即心理社会和身体功能)并减少抑郁。艾滋病毒-通行证不直接治疗药物滥用/滥用，但根据需要明确支持药物滥用治疗。在这项前期工作中，我们对患有慢性疼痛和抑郁症状加重的PLWHA进行了一项HIV-PASS随机对照试验(n=23)和健康教育(HE)对照组。我们建立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，并发现两组之间在结果上的重要差异。在目前的R01应用中，我们建议在有慢性疼痛和抑郁症状加重的PLWHA中进行一项足够强大的HIV-PASS与HE的随机对照试验。我们将招募236名患者，提供超过3个月的干预，并对患者进行总计12个月的随访，以便观察短期和长期效果。我们计划在以下方面对HIV-PASS和HE进行比较：1)3个月急性治疗阶段的主要结果变量，对身体和心理社会功能的干扰(“疼痛干扰”)；2)急性治疗阶段的次要结果变量，包括抑郁、焦虑、体力活动(每天的步数，用加速计测量)、抗逆转录病毒依从性和病毒载量；3)12个月的主要和次要结果变量(即急性治疗阶段+后续阶段)；以及4)成本效益。我们还将研究HIV-PASS可能减少疼痛干扰的机制。

 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.