Goal Management Training for Parkinson Disease Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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Goal Management Training Home-Based Approach for Cognitive Impairment in Parkinson's Disease: A Single-Blind Randomized Trial

Conditions
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Parkinson Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Goal Management Training
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Participants with PD and dementia diagnosis Patients with other neurological or psychiatric disorders.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of two different cognitive intervention (two groups, randomized, single blinded)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Management Training<br>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. | Behavioral: Goal Management Training<br>* 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.<br>|
| Active Comparator: Psychoeducation sessions coupled mindfulness exercises<br>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. | Behavioral: Psychoeducation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raw score Change from baseline DEX (self rated) to 3 weeks after beginning of intervention | Questionnaire on subjective executive functions | 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 | 1 week post-test | 
| Raw score Change from baseline DEX (self rated) to 4 weeks post test | Questionnaire on subjective executive functions | 4 weeks post-test | 
| Raw score Change from baseline DEX (self rated) to 12 weeks post test | Questionnaire on subjective executive functions | 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 | 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 | 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 | 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 | 12 weeks post-test | 
| Raw score Change from baseline Zoo Map Test to 1 week post test | Neuropsychological test assessing planification and organisation | 1 week post-test | 
| Raw score Change from baseline Zoo Map Test to 4 weeks post test | Neuropsychological test assessing planification and organisation | 4 weeks post-test | 
| Raw score Change from baseline Zoo Map Test to 12 weeks post test | Neuropsychological test assessing planification and organisation | 12 weeks post-test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 12 weeks post-test | 
| Raw score Change from baseline Zarit Burden Interview (12 items) to 3 weeks after the beginning of intervention | A 12-item questionnaire assessing the feeling of burden of the caregiver | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). | 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). | 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). | 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). | 12 weeks post-test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, Parkinson Disease, Cognitive Intervention, Goal Management Training, Executive Functions