Meditation and Breathing for Mental Health in Parkinson's Disease Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Compliance
研究概览
简要总结
This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Enrollment into the study will be ongoing until we are able to get a sufficient sample size as described in the "Statistical Consideration" section. Upon enrollment and randomization, surveys will be administered to both the intervention and control groups at four time-points: baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be collected weekly for 12 weeks for both groups.
详细描述
Mental health issues caused by emotional and behavioral changes are common among people diagnosed with Parkinson's disease. Research from the Parkinson's Foundation's Parkinson's Outcomes Project has found that anxiety and depression play a key role in the disease's impact on people's quality of life. The death of dopamine-producing cells in the brain affects both movement and mood. As a result, both anxiety and depression are common non-motor symptoms of the disease rather than reactions to the diagnosis.
According to the Parkinson's Outcomes Project, during their illness:
- At least 50% of people will experience some form of depression
- At least 40% of people will experience an anxiety disorder
Forms of anxiety include Generalized Anxiety Disorder, Anxiety Attacks, Social Avoidance, and OCD1. Depression in Parkinson's disease often manifests as dissatisfaction with life, sadness, irritability, pessimism, and suicidal thoughts.
Meditative techniques have been shown to effectively reduce symptoms of anxiety and depression. Treating these non-motor symptoms can have a positive impact on people with Parkinson's disease by decreasing disability and improving their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 18
- •Interested in attending the Breath, Sound, and Meditation Webinar
- •Diagnosed with Parkinson's Disease
- •PAS score of 12 or higher
- •Able to read and comprehend English.
- •Physically and mentally able to participate in the study procedure
- •Currently residing in the United States.
排除标准
- •Severe stage of PD
- •Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
- •Not able to self-consent to participate in the study
结局指标
主要结局
Change in Compliance
时间窗: For Phase 1 analysis: Baseline to week 6. For Phase 2 analysis: Baseline to week 18.
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Participants completing at least 4 days of activity would be considered as compliant for that week.
Change in Anxiety
时间窗: For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.
Parkinson's Anxiety Scale (PAS) is a 12-item validated observer or patient-rated scale consisting of three subscales for persistent anxiety, episodic anxiety, and avoidance behavior in patients with Parkinson Disease. Participants are asked to rate on a scale of 0 (not or never) and 4 (severe or almost always).
次要结局
- Change in Perceived Stress Scale (PSS)(For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.)
- Change in GRID-Hamilton Depression Scale (HAMD)(For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.)
- Change in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.)
研究者
Balachundhar Subramaniam
Professor of Anesthesia
Beth Israel Deaconess Medical Center