Goal Management Training for Parkinson Disease Mild Cognitive Impairment
- Conditions
- Mild Cognitive ImpairmentParkinson Disease
- Interventions
- Behavioral: Goal Management TrainingBehavioral: Psychoeducation
- Registration Number
- NCT04636541
- Lead Sponsor
- Laval University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- Participants with PD and dementia diagnosis
- Patients with other neurological or psychiatric disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Goal Management Training Goal Management Training GMT modules were adapted for French-speaking patients with PD-MCI. Each session was reduced from nine 90-120-minute sessions (original GMT) to five 60-90-minute sessions, one session per week, in order to avoid fatigue. As for original GMT, participants were given exercises between sessions (mindfulness exercises and metacognitive reflections). In original-GMT, some information is repeated several times, but not in Adapted-GMT. Exercises demanding motor dexterity, such as card distribution, were removed. Adapted-GMT included information on PD-MCI and executive dysfunction (some psychoeducation). In addition, Adapted-GMT modules were administered individually with an iPad, as opposed to a power-point group presentation in original-GMT. A workbook was handed to participants, as in previous studies. Psychoeducation sessions coupled mindfulness exercises Psychoeducation Five modules were designed as a discussion with patients and caregivers about various PD symptoms: module I-brain and motor symptoms; module II-autonomic symptoms; module III- psychological symptoms; module IV-brain and cognition; and module V-cognitive impairments in PD. Patients were handed the information book about the five modules at the beginning of the study. The objective was to improve their understanding of their condition and to discuss other components that could affect their cognitive abilities. After the 40-60-minute informative part, mindfulness exercises were offered for 20-30 minutes per session. Participants were not invited to practice exercises between sessions, but 3/6 participants reported they did.
- Primary Outcome Measures
Name Time Method Raw score Change from baseline DEX (self rated) to 1 week post test 1 week post-test Questionnaire on subjective executive functions
Raw score Change from baseline DEX (self rated) to 4 weeks post test 4 weeks post-test Questionnaire on subjective executive functions
Raw score Change from baseline DEX (caregiver rated) to 4 weeks post test 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 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 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 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 1 week post-test Neuropsychological test assessing planification and organisation
Raw score Change from baseline Zoo Map Test to 12 weeks post test 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 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 12 weeks post-test Questionnaire on subjective executive functions
Raw score Change from baseline Zoo Map Test to 4 weeks post test 4 weeks post-test Neuropsychological test assessing planification and organisation
- Secondary Outcome Measures
Name Time Method Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 1 week post-test 1 week post-test A brief neuropsychological instrument designed to assess general cognitive functioning
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 4 weeks post-test 4 weeks post-test A brief neuropsychological instrument designed to assess general cognitive functioning
Raw score Change from baseline PDQ-39 to 4 weeks post-test 4 weeks post-test Self rated questionnaire on quality of life with symptoms of Parkinson Disease
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) A 12-item questionnaire assessing the feeling of burden of the caregiver
Raw score Change from baseline Zarit Burden Interview (12 items) to 1 week post-test 1 week post-test A 12-item questionnaire assessing the feeling of burden of the caregiver
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 A 12-item questionnaire assessing the feeling of burden of the caregiver
Raw score Change from baseline PDQ-39 to 12 weeks post-test 12 weeks post-test Self rated questionnaire on quality of life with symptoms of Parkinson Disease
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) Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test 1 week post-test assessment of twelve neuropsychiatric symptoms usually found in dementia
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test 4 week post-test assessment of twelve neuropsychiatric symptoms usually found in dementia
Raw score Change from baseline Apathy Evaluation Scale (AES) to 1 week post-test 1 week post-test An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 12 weeks post-test 12 weeks post-test A brief neuropsychological instrument designed to assess general cognitive functioning
Raw score Change from baseline PDQ-39 to 1 week post-test 1 week post-test Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Raw score Change from baseline Zarit Burden Interview (12 items) to 4 weeks post-test 4 weeks post-test A 12-item questionnaire assessing the feeling of burden of the caregiver
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) An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test 12 week post-test assessment of twelve neuropsychiatric symptoms usually found in dementia
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) assessment of twelve neuropsychiatric symptoms usually found in dementia
Raw score Change from baseline Apathy Evaluation Scale (AES) to 4 weeks post-test 4 weeks post-test An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Raw score Change from baseline Apathy Evaluation Scale (AES) to 12 weeks post-test 12 weeks post-test An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Trial Locations
- Locations (1)
School of Psychology
🇨🇦Québec, Canada