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

PATH-Pain：一种基于初级保健的心理社会干预措施，可改善患有 MCI 和早期 AD 的老年人的认知和抑郁结果

• 批准号: 10682594
• 负责人: DIMITRIS N KIOSSES
• 金额: $ 68.54万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10682594
• 关键词: Acceleration; Acute; Address; Affective; Aftercare; Alzheimer' s Disease; Alzheimer' s disease related dementia; Attention; Behavioral; Calendar; Caregivers; Certification; Clinical; Cognition; Cognitive; Cognitive deficits; Data; Dementia; Elderly; Emotional; Emotions; Family member; Feeling hopeless; Friends; Habits; Health; Impaired cognition; Individual; Internal Medicine; Intervention; Interview; Location; Measures; Mediating; Medicine; Mental Depression; Mental Health; Montgomery and Asberg depression rating scale; Neurology; Neuropsychology; Outcome; Pain; Pain intensity; Pain management; Pamphlets; Participant; Patients; Persons; Pharmaceutical Preparations; Population; Primary Care; Probability; Problem Solving; Procedures; Psychiatry; Public Health; Questionnaires; Randomized; Reaction; Recommendation; Research Assistant; Research Personnel; Resources; Risk; Severities; Site; Stress; Structure; Tablets; Techniques; Telephone; Testing; Time; acceptability and feasibility; attentional control; chronic depression; chronic pain; chronic pain patient; clinically significant; cognitive function; cognitive testing; comorbid depression; comorbidity; dementia risk; depressive symptoms; distraction; emotion dysregulation; emotion regulation; environmental adaptation; experience; follow-up; functional outcomes; improved; innovation; member; mild cognitive impairment; novel; pain outcome; pain reduction; pain-related disability; perceived stress; positive emotional state; power analysis; primary outcome; psychosocial; recruit; satisfaction; secondary outcome; sex; stress reduction; sustained attention; telephone session; therapy design; tool; treatment as usual; treatment effect; usual care arm

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.

该 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，旨在解决患有慢性疼痛和抑郁症的患者的 MCI（轻度认知障碍）和早期 AD/ADRD 问题。疼痛适应疗法 (PATH-Pain) 是一种基于初级保健的新型心理社会干预措施，旨在减轻患有抑郁症和疼痛的 MCI 和早期 AD/ADRD 患者的压力，具有更好的认知、情感和功能结果优于注意力控制日常护理。 PATH-Pain 是一种易于实施的心理社会干预措施，旨在改善患有 MCI 或早期 AD/ADRD、慢性疼痛和抑郁症的老年人的情绪调节和减轻压力。为了减轻压力，PATH-Pain 旨在：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（例如绝望、无助）； c) 增加积极情绪并增加对愉快活动的参与 d) 帮助患者识别可解决的问题；并尝试找到解决这些问题的最佳方法； e) 减少患者与家人、护理人员和朋友之间的人际关系紧张；以及 f) 在经历疼痛时转移注意力以减轻疼痛强度。 -疼痛采用情绪调节、问题解决和行为激活技术，PATH-Pain 参与者对干预表现出很高的接受度和治疗满意度。 根据我们的功效分析，我们将 100 名患有 MCI 或早期痴呆症（可能或可能患有阿尔茨海默病）、共病抑郁症和慢性疼痛的老年人（60 岁及以上）随机分组，接受每周 8 次的门诊治疗和每月 6 次电话咨询（在 4 个初级保健中心进行 3 次个人和 3 次小组的 PATH-疼痛与注意力控制日常护理课程 注意力控制日常护理部门包括日常护理、关于疼痛和注意力的小册子。结构化访谈的目的是控制注意力和时间，并将包括有关健康习惯和其他与认知障碍、疼痛无关的非医学主题的一般问题。研究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。评估将在第 5 周（无认知结果）、第 9 周、第 24 周（无认知结果）、第 36 周进行。 52 名研究助理不了解研究假设和参与者的随机化状态的 PATH-Pain 将由经过认证的心理健康工作者进行，注意力控制课程将由具有结构化访谈经验的非临床医生团队成员进行。