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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
12
Goal Management Training® (GMT) has been developed to improve executive functions. It was validated in patients presenting executive dysfunction following many conditions: acquired traumatic brain injury, neurodevelopmental spina bifida, attention deficit and hyperactivity disorder (ADHD), subjective cognitive complaints and multiple sclerosis. GMT includes self-instruction strategies, self-monitoring exercises, cognitive training techniques, psychoeducation on cognitive processes, mindfulness exercises and assignments between sessions. It has been shown to increase patient awareness of deficits and improve cognitive control in goal-directed behaviors. The original GMT is a nine-week program administered to dysexecutive patients in 90-to-120-minute group sessions. Thus, it might be suitable for PD-MCI patients presenting with executive dysfunction.
See the Arm section for full details. For a justification of how we designed this intervention: Many clinical guidelines include general recommendations about giving information to PD patients and family so they can take part into decision process. However, few standardized psychoeducation interventions are available, and they don't include information on PD cognitive decline. Some studies investigated Mindfulness Based Stress Reduction (MBSR) and other related mindfulness interventions in PD patients. In this approach, formal meditative exercises are included to develop non-judgmental attention to experiences in the present moment. In elderly patients with MCI unrelated to PD, mindfulness interventions show positive effects on cognitive functioning, including attention, executive functioning and memory (Gard et al., 2014). Therefore, non-pharmacological interventions for PD-MCI including both education on cognitive symptoms, as well as mindfulness exercises, are promising.
School of Psychology
Québec, Canada
Raw score Change from baseline DEX (self rated) to 3 weeks after beginning of intervention
Questionnaire on subjective executive functions
Time frame: 3 weeks after beginning of intervention (mid-point)
Raw score Change from baseline DEX (self rated) to 1 week post test
Questionnaire on subjective executive functions
Time frame: 1 week post-test
Raw score Change from baseline DEX (self rated) to 4 weeks post test
Questionnaire on subjective executive functions
Time frame: 4 weeks post-test
Raw score Change from baseline DEX (self rated) to 12 weeks post test
Questionnaire on subjective executive functions
Time frame: 12 weeks post-test
Raw score Change from baseline DEX (caregiver rated) to 3 weeks after the beginning of intervention
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Time frame: 3 weeks after beginning of intervention (mid-point)
Raw score Change from baseline DEX (caregiver rated) to 1 week post test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Time frame: 1 week post-test
Raw score Change from baseline DEX (caregiver rated) to 4 weeks post test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Time frame: 4 weeks post-test
Raw score Change from baseline DEX (caregiver rated) to 12 weeks post test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Time frame: 12 weeks post-test
Raw score Change from baseline Zoo Map Test to 1 week post test
Neuropsychological test assessing planification and organisation
Time frame: 1 week post-test
Raw score Change from baseline Zoo Map Test to 4 weeks post test
Neuropsychological test assessing planification and organisation
Time frame: 4 weeks post-test
Raw score Change from baseline Zoo Map Test to 12 weeks post test
Neuropsychological test assessing planification and organisation
Time frame: 12 weeks post-test
Raw score Change from baseline Parkinson Disease Questionnaire (39 items; PDQ-39) to 3 weeks after the beginning of intervention
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Time frame: 3 weeks after beginning of intervention (mid-point of intervention)
Raw score Change from baseline PDQ-39 to 1 week post-test
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Time frame: 1 week post-test
Raw score Change from baseline PDQ-39 to 4 weeks post-test
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Time frame: 4 weeks post-test
Raw score Change from baseline PDQ-39 to 12 weeks post-test
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Time frame: 12 weeks post-test
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 1 week post-test
A brief neuropsychological instrument designed to assess general cognitive functioning
Time frame: 1 week post-test
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 4 weeks post-test
A brief neuropsychological instrument designed to assess general cognitive functioning
Time frame: 4 weeks post-test
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 12 weeks post-test
A brief neuropsychological instrument designed to assess general cognitive functioning
Time frame: 12 weeks post-test
Raw score Change from baseline Zarit Burden Interview (12 items) to 3 weeks after the beginning of intervention
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A 12-item questionnaire assessing the feeling of burden of the caregiver
Time frame: 3 weeks after the beginning of intervention (mid-point)
Raw score Change from baseline Zarit Burden Interview (12 items) to 1 week post-test
A 12-item questionnaire assessing the feeling of burden of the caregiver
Time frame: 1 week post-test
Raw score Change from baseline Zarit Burden Interview (12 items) to 4 weeks post-test
A 12-item questionnaire assessing the feeling of burden of the caregiver
Time frame: 4 weeks post-test
Raw score Change from baseline Zarit Burden Interview (12 items) to 12 week post-test
A 12-item questionnaire assessing the feeling of burden of the caregiver
Time frame: Baseline, mid-point of intervention, 1 week post-test, 4 weeks post-test and 12 weeks post-test
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 3 weeks after the beginning of intervention (mid-point)
assessment of twelve neuropsychiatric symptoms usually found in dementia
Time frame: 3 weeks after the beginning of intervention (mid-point)
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test
assessment of twelve neuropsychiatric symptoms usually found in dementia
Time frame: 1 week post-test
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test
assessment of twelve neuropsychiatric symptoms usually found in dementia
Time frame: 4 week post-test
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test
assessment of twelve neuropsychiatric symptoms usually found in dementia
Time frame: 12 week post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 3 weeks after the beginning of intervention (mid-point)
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Time frame: 3 weeks after the beginning of intervention (mid-point)
Raw score Change from baseline Apathy Evaluation Scale (AES) to 1 week post-test
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Time frame: 1 week post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 4 weeks post-test
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Time frame: 4 weeks post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 12 weeks post-test
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Time frame: 12 weeks post-test