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 R 01结合了威尔康奈尔大学医学院精神病学，神经病学和内科的专业知识，以解决MCI（轻度认知障碍）和早期AD/ADRD共病慢性疼痛和抑郁症患者的问题。我们建议测试疼痛问题适应疗法（PATH-Pain），一种新的基于初级保健的心理社会干预，旨在减少MCI和早期AD/ADRD患者抑郁和疼痛共病的压力，是否比注意力控制护理具有更好的认知，情感和功能结果。 PATH-Pain是一种易于管理的心理社会干预，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并减轻压力。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）增加积极的情绪，增加对愉快活动的参与; d）帮助患者识别他们生活中可解决的问题，并试图找到解决这些问题的最佳方案; e）减少患者与家庭成员，照顾者和朋友之间的人际紧张关系; f）在疼痛体验期间转移注意力，以减轻疼痛强度。为了实现这些目标，PATH-Pain采用情绪调节，解决问题和行为激活技术。在我们的初步研究中，PATH-Pain参与者对干预表现出较高的可接受性和治疗满意度。 根据我们的功效分析，我们将100名患有MCI或早期痴呆（可能或可能的阿尔茨海默病）、共病抑郁症和慢性疼痛的老年人（60岁及以上）随机分配至4个初级保健中心的8个每周一次的办公室会议和6个每月一次的电话会议（3个人和3个小组）。注意力控制的心理护理组包括心理护理、关于疼痛和抑郁的小册子以及与每次病理疼痛会议相同持续时间的结构化访谈。结构化访谈旨在控制注意力和时间，并将包括有关健康习惯的一般问题和与认知障碍，疼痛和抑郁无关的其他非医学主题。研究者已经证明了拟定研究的招募、保留和评估程序的可行性。将在基线和第5周（无认知结局）、第9周、第24周（无认知结局）、第36周和第52周由不了解研究假设和受试者随机化状态的研究助理进行评估。路径-疼痛将由经认证的精神卫生工作者进行，注意力控制课程将由在结构化访谈中有经验的非临床医生团队成员进行。