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（PLWHA）的一个重要问题。30%至65%接受艾滋病毒治疗的患者有疼痛，干扰日常活动。虽然治疗疼痛的药理学选择通常只是部分有效，但很少有关于旨在解决疼痛干扰PLWHA功能（或其他疼痛结果）的非药理学治疗的研究。艾滋病毒感染者/艾滋病患者的疼痛治疗因抑郁症和药物误用/滥用等合并症而进一步复杂化。慢性疼痛和抑郁症状（在艾滋病毒/艾滋病感染者中非常普遍）的共同出现与增加的痛苦和残疾有关，相对于任何一个单独的问题。慢性疼痛和抑郁都增加了不坚持抗逆转录病毒治疗的风险。艾滋病毒/艾滋病感染者经常在初级保健机构接受护理，随着为患有复杂慢性病的患者设立的"医疗之家"的增多，对身体疼痛和抑郁症进行协调的初级保健治疗可能是艾滋病毒长期护理的一个良好模式。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的心理社会干预治疗方法，用于在初级保健中管理PLWHA的疼痛和抑郁。这项名为HIV-PASS（HIV疼痛和悲伤研究）的干预措施整合并建立在慢性疼痛和抑郁症的行为疗法基础上。HIV-PASS的目标是教会患者减少行为回避和增加参与日常有价值活动的技能，从而最终提高功能能力（即，心理社会和身体功能）和减少抑郁症。HIV-PASS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。在这项初步工作中，我们进行了一项随机对照试验（n = 23）的艾滋病毒-PASS与健康教育（HE）对照组的艾滋病毒感染者与慢性疼痛和抑郁症状升高。我们在几个指标上建立了可行性和可接受性，包括患者对治疗方案的依从性，并发现组间结局差异很重要。在目前的R01申请中，我们建议在患有慢性疼痛和抑郁症状加重的PLWHA中进行一项充分把握度的随机对照试验，比较HIV-PASS与HE。我们将招募236名患者，提供3个月以上的干预措施，并对患者进行总共12个月的随访，以便我们可以观察短期和长期效果。我们计划比较HIV-PASS和HE：1）主要结果变量，对身体和心理功能的干扰（"疼痛干扰"）; 2）急性治疗期的次要结局变量，包括抑郁、焦虑、体力活动（每天步数，用加速计测量）、抗逆转录病毒依从性和病毒载量; 3）12个月内的主要和次要结果变量（即，急性治疗期+随访期）;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.