Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study

基于正念的帕金森病减压：一项纵向研究

• 批准号: 10051337
• 负责人: Dawn M. Schiehser
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-11-01 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10051337
• 关键词: Activities of Daily Living; Address; Aftercare; Anxiety; Attention; Attenuated; Blinded; Caring; Chronic; Climacteric; Cognition; Cognitive; Communication; Control Groups; Data; Disease; Elderly; Enrollment; Ensure; Evaluation; Frequencies; Future; Goals; Healthcare; Healthcare Systems; Impaired cognition; Individual; Institutes; Intervention; Longevity; Longitudinal Studies; Measures; Mediating; Mediation; Mediator of activation protein; Medical; Memory; Mental Depression; Mission; Modeling; Moods; Motor; Neurobehavioral Manifestations; Neurodegenerative Disorders; Neurologic; Neuropsychological Tests; Outcome; Outcome Measure; Parkinson Disease; Participant; Patients; Pilot Projects; Population; Publishing; Quality of Care; Questionnaires; Randomized; Randomized Controlled Trials; Role; Sample Size; Sampling; Severity of illness; Social support; Supportive care; Symptoms; Testing; Time; United States Department of Veterans Affairs; Veterans; Veterans Health Administration; Well in self; active control; anxiety symptoms; associated symptom; behavioral health intervention; clinical care; cognitive ability; disabling disease; efficacious treatment; efficacy evaluation; executive function; experience; follow up assessment; follow-up; health related quality of life; improved; indexing; mindfulness; mindfulness-based stress reduction; mood symptom; motor symptom; non-demented; non-motor symptom; pilot trial; post intervention; primary outcome; programs; psychoeducation; psychoeducational; recruit; secondary analysis; social stigma; treatment comparison; treatment response

Over 80,000 Veterans with Parkinson’s disease (PD) currently obtain their medical care within the VA Healthcare System, and the number of Veterans with PD is expected to increase considerably in the near future. Health-related Quality of Life (HRQoL) is severely compromised in those with PD and worsens as the disease progresses. Non-motor symptoms, particularly impaired cognition and mood (anxiety and depression), contribute to poor and worsening of HRQoL in PD. Therefore, interventions that target these symptoms and improve HRQoL are critically needed. Mindfulness-based Stress Reduction (MBSR) in a non-pharmacological intervention that has been shown to improve HRQoL, mood, and cognition in older adults with and without neurological conditions. Although preliminary evidence supports MBSR as a promising intervention for PD, a systematic, comprehensive randomized controlled trial (RCT) of MBSR has yet to be conducted in this population. Moreover, it is unknown if immediate preliminary benefits are maintained over time. As PD is a neurodegenerative disorder, non-transient benefits are of paramount importance in the treatment of this chronic, disabling disease. Results from our pilot trial (n = 20) demonstrated that PD participants who completed an 8-week MBSR program (n = 8) evidenced an improvement in overall HRQoL (d’ = 1.1), cognition (d’ = 1.6), and mood (anxiety; d’ = 1.1), compared to PD participants in an 8-week active control condition (Psychoeducation/Supportive Care; n = 12); the latter of whom experienced a worsening of symptoms. These findings provide compelling preliminary evidence of MBSR efficacy for PD, and strongly underscore the need for adequate treatment of PD-related non-motor symptoms with empirically-validated interventions. The overall aim of this longitudinal RCT is to determine the efficacy of MBSR to improve HRQoL, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with PD. We hypothesize that HRQoL, cognition (particularly executive function), and mood (particularly anxiety) symptoms (will improve in PD participants following eight weeks of MBSR compared to PD participants randomized to an eight-week active Psychoeducation control condition. We further hypothesize that benefits of MBSR treatment will be evident at the 6- and 12-month assessments, such that those completing the MBSR group will demonstrate better HRQoL, cognition, and mood relative to those PD patients who completed the Psychoeducation/Supportive Care (PSC) group. Potential mediators/moderators of the treatment response will be examined in exploratory hypotheses. Eighty-eight non-demented individuals with PD will be recruited and enrolled in the proposed study. Over-recruitment by 10% will be instituted to account for subject attrition or unusable data, and to ensure an adequately-powered sample size of 80 (40 per group). Participants will be randomized into either eight of weeks of MBSR (n = 44) or eight weeks of PSC (n = 44). All participants will be administered a battery of neuropsychological tests to measure HRQoL, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. Tests will be administered at baseline, 8 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment. Data will be primarily analyzed using linear and multivariable random effects modeling. Findings from this study will provide critical information regarding the efficacy of MBSR for HRQoL, cognition, and mood in PD. Furthermore, results will provide essential data regarding the long-term benefits of MBSR in PD, and elucidate potential mediators/moderators of treatment response. Ultimately, this study will contribute to the VA mission by establishing an empirically-validated intervention for Veterans and civilians with PD that can be easily and widely implemented and disseminated throughout the VA Healthcare System.

超过80，000名患有帕金森病（PD）的退伍军人目前在VA内获得医疗护理 医疗保健系统，和退伍军人与PD的数量预计将大大增加，在不久的将来 未来健康相关生活质量（HRQoL）在PD和PD患者中严重受损， 疾病进展。非运动症状，特别是认知和情绪受损（焦虑和 抑郁症），导致PD患者HRQoL较差和恶化。因此，针对这些问题的干预措施 症状和改善HRQoL是迫切需要的。 正念减压（MBSR）是一种非药物干预， 在有和没有神经系统疾病的老年人中显示出改善HRQoL，情绪和认知。 虽然初步证据支持正念减压疗法是一种有希望的PD干预措施， 在这一人群中尚未进行全面的正念减压随机对照试验（RCT）。 此外，目前还不清楚，随着时间的推移，是否能保持即时的初步效益。因为PD是一个 神经退行性疾病，非短暂的好处是至关重要的治疗这一点 慢性致残性疾病我们的初步试验（n = 20）的结果表明， 完成8周的正念减压治疗（n = 8）后，总体HRQoL（d' = 1.1）、认知功能、 （d' = 1.6）和情绪（焦虑; d' = 1.1），与8周主动控制条件下的PD参与者相比 （心理教育/支持性护理; n = 12）;后者出现症状恶化。这些 这些发现为正念减压疗法治疗帕金森病提供了令人信服的初步证据，并强烈强调了需要 通过经临床验证的干预措施充分治疗PD相关的非运动症状。 这项纵向随机对照试验的总体目标是确定正念减压疗法改善HRQoL的疗效， 认知和情绪，以及确定PD患者治疗反应的持续时间。 我们假设HRQoL、认知（特别是执行功能）和情绪（特别是焦虑） 症状（与PD参与者相比，PD参与者在8周的MBSR后将改善 随机分配到为期八周的积极心理教育对照组。我们进一步假设， 在6个月和12个月的评估中， 组将表现出更好的HRQoL，认知和情绪相对于那些完成了 心理教育/支持性护理组。治疗反应的潜在介质/调节剂 将在探索性假设中进行检验。将招募88名患有PD的非痴呆个体 并参加了拟定的研究。将制定10%的超额招募，以解释受试者流失 或不可用的数据，并确保有足够把握度的样本量为80（每组40）。参与者将 随机分为8周MBSR（n = 44）或8周PSC（n = 44）。所有参与者 将进行一系列神经心理学测试，以测量HRQoL，认知（例如，执行 功能、注意力、记忆力）和情绪（即，焦虑、抑郁和冷漠），以及运动症状， 疾病的严重程度和正念参与/实践。将在基线、8周时进行检查 （治疗后）以及6个月和12个月（随访评估），由对组设盲的检查者进行 派任将使用线性和多变量随机效应模型对数据进行主要分析。 这项研究的结果将提供关于正念减压疗法对HRQoL疗效的关键信息， 认知和情绪。此外，结果将提供有关长期效益的基本数据 的MBSR在PD，并阐明治疗反应的潜在介质/调节剂。最终，这项研究 将通过为退伍军人和平民建立一个经过验证的干预措施，为退伍军人事务部的使命做出贡献 与PD，可以很容易地和广泛地实施和传播整个VA医疗保健系统。