PATH-Pain: A Primary Care-Based Psychosocial Intervention To Improve Cognitive and Depression Outcomes in Older Adults with MCI and Early Stage AD

这款MPI R01结合了威尔·康奈尔医学院精神病学、神经病学和内科的专业知识，用于治疗患有慢性疼痛和抑郁的患者的轻度认知障碍(MCI)和早期AD/ADRD。我们建议测试疼痛问题适应疗法(路径疼痛)，一种新的基于初级护理的心理社会干预，旨在减少MCI和早期AD/ADRD患者的压力，并伴有抑郁和疼痛，是否有比注意控制通常护理更好的认知、情感和功能结果。 路径疼痛是一种易于管理的心理社会干预措施，旨在改善MCI或早期AD/ADRD、慢性疼痛和抑郁症老年人的情绪调节和减轻压力。为了减轻压力，Path-Pain的目标是：a)减少与疼痛和疼痛相关的残疾相关的负面情绪；b)减少干扰疼痛治疗的负面情绪(如绝望、无助)；c)增加积极的情绪和更多地参与愉快的活动；d)帮助患者识别生活中可以解决的问题并试图找到这些问题的最佳解决方案；e)减少患者与家人、照顾者和朋友之间的人际紧张关系；以及f)在经历疼痛的过程中转移注意力，以降低疼痛强度。为了达到这些目的，路径疼痛使用了情绪调节、问题解决和行为激活技术。在我们的初步研究中，路径疼痛参与者对干预表现出很高的可接受性和治疗满意度。 基于我们的能力分析，我们将随机选择100名患有MCI或早期痴呆(可能或可能的阿尔茨海默病)、患有抑郁症和慢性疼痛的老年人(60岁及以上)，在4个初级保健地点进行每周8次办公室会议和6次每月电话会议(3个人和3个小组)与注意力控制日常护理。注意力控制常规护理臂包括常规护理、关于疼痛和抑郁的小册子，以及与每一次路径疼痛会议相同持续时间的结构化访谈。结构化面试旨在控制注意力和时间，包括关于健康习惯的一般性问题，以及其他与认知障碍、疼痛和抑郁无关的非医学话题。调查人员已经证明了拟议研究的招募、保留和评估程序的可行性。评估将在基线和第5周(无认知结果)、第9周、第24周(无认知结果)、第36周和第52周由不知道研究假设和参与者随机状态的研究助理进行。路径疼痛将由经认证的精神卫生工作者进行管理，注意力控制会议将由具有结构化访谈经验的非临床医生团队成员进行管理。

This MPI R01 combines the expertise of the Departments of Psychiatry, Neurology, and Internal Medicine at Weill Cornell Medicine to address MCI (mild cognitive impairment) and early stage AD/ADRD in patients with comorbid chronic pain and depression. We propose to test whether Problem Adaptation Therapy for Pain (PATH-Pain), a novel primary-care based psychosocial intervention designed to reduce stress in MCI and early stage AD/ADRD patients with comorbid depression and pain, has better cognitive, affective, and functional outcomes than Attention Control Usual Care. PATH-Pain is an easy-to-administer psychosocial intervention designed to improve emotion regulation and reduce stress in older adults with MCI or early stage AD/ADRD, chronic pain, and depression. To reduce stress, PATH-Pain aims to: a) reduce negative emotions associated with pain and pain-related disability; b) reduce negative emotions that interfere with pain treatment (e.g., hopelessness, helplessness); c) increase positive emotions and increase engagement in pleasurable activities; d) help patients identify addressable problems in their lives and try to find the best possible solution to these problems; e) reduce interpersonal tension between patients and family members, caregivers, and friends; and f) shift attention during experiences of pain to reduce pain intensity. To achieve these aims, PATH-Pain employs emotion regulation, problem solving, and behavioral activation techniques. In our preliminary study, PATH-Pain participants showed high acceptability and treatment satisfaction with the intervention. Based on our power analysis, we will randomize 100 older adults (60 years and older) with MCI or early stage dementia (probable or possible Alzheimer’s Disease), comorbid depression, and chronic pain to 8 weekly in-office sessions and 6 monthly phone (3 individual and 3 group) sessions of PATH-Pain vs. Attention Control Usual Care in 4 primary care sites. The Attention Control Usual Care arm consists of Usual Care, a pamphlet on pain and depression, and a structured interview of the same duration as each PATH-Pain session. The structured interview aims to control for attention and time, and will consist of general questions regarding health habits and other non-medical topics unrelated to cognitive impairment, pain, and depression. The investigators have shown evidence of feasibility of recruitment, retention, and assessment procedures for the proposed study. Assessments will be performed at baseline, and weeks 5 (no cognitive outcomes), 9, 24 (no cognitive outcomes), 36, and 52 by research assistants unaware of the study hypotheses and the participants’ randomization status. PATH-Pain will be administered by certified mental health workers and the Attention-Control sessions will be administered by a non-clinician team member experienced in structured interviews.