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: 10534124
• 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 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10534124
• 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.

目前，有80,000多名帕金森氏病（PD）的退伍军人目前在VA中获得医疗服务 医疗保健系统和PD的退伍军人人数预计将在附近保守地增加 未来。与健康相关的生活质量（HRQOL）在患有PD的患者中受到严重损害 疾病进展。非运动症状，尤其是认知和情绪受损（焦虑和 抑郁症，有助于PD中的HRQOL差和担心。因此，针对这些的干预措施 症状并改善HRQOL是至关重要的。 基于正念的压力减轻（MBSR）在非药物干预中 证明可以改善有和没有神经系统疾病的老年人的HRQOL，情绪和认知。 尽管初步证据支持MBR作为PD的承诺干预，这是一种系统的， MBSR的全面随机对照试验（RCT）尚未在该人群中进行。 此外，未知是否会随着时间的推移维持即时的初步福利。因为PD是一个 神经退行性障碍，非传播益处对于治疗这一点至关重要 慢性致残疾病。我们的试点试验（n = 20）的结果表明，PD参与者 完成了为期8周的MBSR计划（n = 8）证明了整体HRQOL（D'= 1.1），认知的改善 （D'= 1.6）和情绪（焦虑; d'= 1.1），与PD参与者相比为8周 （心理教育/支持护理； n = 12）;后者担心症状。这些 调查结果为PD提供了令人信服的MBSR效率的初步证据，并强烈强调了需求 为了充分治疗与PD相关的非运动症状，并具有经验验证的干预措施。 该纵向RCT的总体目的是确定MBSR提高HRQOL的效率， 认知和情绪，以及确定PD患者治疗反应的寿命。 我们假设HRQOL，认知（特别是执行功能）和情绪（尤其是动画） 症状（与PD参与者相比，MBSR八周后，PD参与者将改善PD参与者 随机分配为八周的活动性心理教育控制条件。我们进一步假设有好处 在6个月和12个月的评估中，MBSR治疗将是完成MBSR的证据 相对于那些完成的PD患者，小组将表现出更好的HRQOL，认知和情绪 心理教育/支持护理（PSC）组。治疗反应的潜在介体/主持人 将在探索性假设中进行检查。将招募八十八名非痴呆的人 并参加了拟议的研究。过度招聘将建立10％以解释主题流失 或无法使用的数据，并确保有足够的样本量为80（每组40）。参与者会 被随机分为MBSR的八周（n = 44）或PSC八周（n = 44）。所有参与者 将管理一系列神经心理学测试，以测量HRQOL，认知（例如，执行官 功能，注意力，记忆）和情绪（即动画，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。测试将在基线时进行8周 （治疗后），以及一名对小组蒙蔽的检查员的6个月和12个月（随访评估） 任务。数据将主要使用线性和多变量随机效应建模来分析。 这项研究的发现将提供有关MBSR效率HRQOL的关键信息， 认知和心情。此外，结果将提供有关长期利益的基本数据 MBSR在PD中，并阐明了治疗反应的潜在介体/主持人。最终，这项研究 将通过为退伍军人和平民建立经验验证的干预来为VA任务做出贡献 PD可以在整个VA医疗保健系统中轻松，广泛地实施和传播。