Goal Management Training Home-Based Approach for Cognitive Impairment in Parkinson's Disease: A Single-Blind Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Raw score Change from baseline DEX (self rated) to 1 week post test
研究概览
简要总结
Mild cognitive impairment is experienced by approximately 30% of patients with Parkinson's disease (PD-MCI), often affecting executive functions. There is currently no pharmacological treatment available for PD-MCI and non-pharmacological treatments are still scarce. The aim of this study was to test preliminary efficacy/effectiveness of two home-based cognitive interventions adapted for patients with PD-MCI: Goal Management Training, adapted for PD-MCI (Adapted-GMT), and a psychoeducation program combined with mindfulness exercises. Twelve persons with PD-MCI with executive dysfunctions, as measured by extensive neuropsychological evaluation, were randomly assigned to one of two intervention groups. Both groups received five sessions each lasting 60-90 minutes for five weeks, in presence of the caregiver. Measures were collected at baseline, mid-point, at one-week, four-week and 12-week follow-ups. Primary outcomes were executive functions assessed by subjective (DEX questionnaire patient- and caregiver-rated) and objective (Zoo Map Test) measures. Secondary outcomes included quality of life (PDQ-39), global cognition (DRS-II), and neuropsychiatric symptoms (NPI-12). Safety data (fatigue, medication change and compliance) were also recorded. Repeated measures ANCOVAs were applied to outcomes. Both groups significantly ameliorated executive functions overtime as indicated by improvements in DEX-patient and DEX-caregiver scores. PDQ-39 scores decreased at the four-week follow-up in the Psychoeducation/Mindfulness group whereas they were maintained in the Adapted-GMT group. All other measures were maintained over time in both groups. Adapted-GMT and Psychoeducation/Mindfulness groups both improved executive functioning. This is one of the first studies to test home-based approaches, tailored to the participant's cognitive needs, and involving caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The research was a single blind randomized comparative study. After the screening evaluation, participants were randomly assigned to either group A or B, described below (block randomization, three blocks of four participants).
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD diagnosis from the United Kingdom Research Brain Bank diagnostic criteria for PD (Hughes et al., 1992);
- •PD-MCI diagnosis from the Movement Disorder Society Task Force diagnostic criteria. Single and multiple-domain MCI were both included, only if executive functions were significantly impaired (-1 standard deviation on executive function tests according to age and education-adjusted norms);
- •Montreal Cognitive Assessment scores between 21 and 27;
- •Anti-Parkinson medication stable (at screening) since at least two months;
- •All other medications, including psychotropics, stable for at least three months.
排除标准
- •Participants with PD and dementia diagnosis
- •Patients with other neurological or psychiatric disorders.
结局指标
主要结局
Raw score Change from baseline DEX (self rated) to 1 week post test
时间窗: 1 week post-test
Questionnaire on subjective executive functions
Raw score Change from baseline DEX (self rated) to 4 weeks post test
时间窗: 4 weeks post-test
Questionnaire on subjective executive functions
Raw score Change from baseline DEX (caregiver rated) to 4 weeks post test
时间窗: 4 weeks post-test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Raw score Change from baseline DEX (caregiver rated) to 3 weeks after the beginning of intervention
时间窗: 3 weeks after beginning of intervention (mid-point)
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Raw score Change from baseline DEX (caregiver rated) to 12 weeks post test
时间窗: 12 weeks post-test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Raw score Change from baseline DEX (caregiver rated) to 1 week post test
时间窗: 1 week post-test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Raw score Change from baseline Zoo Map Test to 1 week post test
时间窗: 1 week post-test
Neuropsychological test assessing planification and organisation
Raw score Change from baseline Zoo Map Test to 12 weeks post test
时间窗: 12 weeks post-test
Neuropsychological test assessing planification and organisation
Raw score Change from baseline DEX (self rated) to 3 weeks after beginning of intervention
时间窗: 3 weeks after beginning of intervention (mid-point)
Questionnaire on subjective executive functions
Raw score Change from baseline DEX (self rated) to 12 weeks post test
时间窗: 12 weeks post-test
Questionnaire on subjective executive functions
Raw score Change from baseline Zoo Map Test to 4 weeks post test
时间窗: 4 weeks post-test
Neuropsychological test assessing planification and organisation
次要结局
- Raw score Change from baseline PDQ-39 to 4 weeks post-test(4 weeks post-test)
- Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 1 week post-test(1 week post-test)
- Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 4 weeks post-test(4 weeks post-test)
- Raw score Change from baseline Zarit Burden Interview (12 items) to 3 weeks after the beginning of intervention(3 weeks after the beginning of intervention (mid-point))
- Raw score Change from baseline Zarit Burden Interview (12 items) to 1 week post-test(1 week post-test)
- Raw score Change from baseline Zarit Burden Interview (12 items) to 12 week post-test(Baseline, mid-point of intervention, 1 week post-test, 4 weeks post-test and 12 weeks post-test)
- Raw score Change from baseline Parkinson Disease Questionnaire (39 items; PDQ-39) to 3 weeks after the beginning of intervention(3 weeks after beginning of intervention (mid-point of intervention))
- Raw score Change from baseline PDQ-39 to 12 weeks post-test(12 weeks post-test)
- Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test(1 week post-test)
- Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test(4 week post-test)
- Raw score Change from baseline Apathy Evaluation Scale (AES) to 1 week post-test(1 week post-test)
- Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 12 weeks post-test(12 weeks post-test)
- Raw score Change from baseline Zarit Burden Interview (12 items) to 4 weeks post-test(4 weeks post-test)
- Raw score Change from baseline PDQ-39 to 1 week post-test(1 week post-test)
- Raw score Change from baseline Apathy Evaluation Scale (AES) to 3 weeks after the beginning of intervention (mid-point)(3 weeks after the beginning of intervention (mid-point))
- Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test(12 week post-test)
- Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 3 weeks after the beginning of intervention (mid-point)(3 weeks after the beginning of intervention (mid-point))
- Raw score Change from baseline Apathy Evaluation Scale (AES) to 4 weeks post-test(4 weeks post-test)
- Raw score Change from baseline Apathy Evaluation Scale (AES) to 12 weeks post-test(12 weeks post-test)