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Goal Management Training for Parkinson Disease Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT04636541
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Mild Cognitive Impairment Behavioral: Goal Management Training Behavioral: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of two different cognitive intervention (two groups, randomized, single blinded)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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).
Primary Purpose: Supportive Care
Official Title: Goal Management Training Home-Based Approach for Cognitive Impairment in Parkinson's Disease: A Single-Blind Randomized Trial
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : July 20, 2019
Actual Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Goal Management Training
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.

Active Comparator: Psychoeducation sessions coupled mindfulness exercises
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
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.




Primary Outcome Measures :
  1. Raw score Change from baseline DEX (self rated) to 3 weeks after beginning of intervention [ Time Frame: 3 weeks after beginning of intervention (mid-point) ]
    Questionnaire on subjective executive functions

  2. Raw score Change from baseline DEX (self rated) to 1 week post test [ Time Frame: 1 week post-test ]
    Questionnaire on subjective executive functions

  3. Raw score Change from baseline DEX (self rated) to 4 weeks post test [ Time Frame: 4 weeks post-test ]
    Questionnaire on subjective executive functions

  4. Raw score Change from baseline DEX (self rated) to 12 weeks post test [ Time Frame: 12 weeks post-test ]
    Questionnaire on subjective executive functions

  5. Raw score Change from baseline DEX (caregiver rated) to 3 weeks after the beginning of intervention [ Time Frame: 3 weeks after beginning of intervention (mid-point) ]
    Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant

  6. Raw score Change from baseline DEX (caregiver rated) to 1 week post test [ Time Frame: 1 week post-test ]
    Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant

  7. Raw score Change from baseline DEX (caregiver rated) to 4 weeks post test [ Time Frame: 4 weeks post-test ]
    Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant

  8. Raw score Change from baseline DEX (caregiver rated) to 12 weeks post test [ Time Frame: 12 weeks post-test ]
    Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant

  9. Raw score Change from baseline Zoo Map Test to 1 week post test [ Time Frame: 1 week post-test ]
    Neuropsychological test assessing planification and organisation

  10. Raw score Change from baseline Zoo Map Test to 4 weeks post test [ Time Frame: 4 weeks post-test ]
    Neuropsychological test assessing planification and organisation

  11. Raw score Change from baseline Zoo Map Test to 12 weeks post test [ Time Frame: 12 weeks post-test ]
    Neuropsychological test assessing planification and organisation


Secondary Outcome Measures :
  1. Raw score Change from baseline Parkinson Disease Questionnaire (39 items; PDQ-39) to 3 weeks after the beginning of intervention [ Time Frame: 3 weeks after beginning of intervention (mid-point of intervention) ]
    Self rated questionnaire on quality of life with symptoms of Parkinson Disease

  2. Raw score Change from baseline PDQ-39 to 1 week post-test [ Time Frame: 1 week post-test ]
    Self rated questionnaire on quality of life with symptoms of Parkinson Disease

  3. Raw score Change from baseline PDQ-39 to 4 weeks post-test [ Time Frame: 4 weeks post-test ]
    Self rated questionnaire on quality of life with symptoms of Parkinson Disease

  4. Raw score Change from baseline PDQ-39 to 12 weeks post-test [ Time Frame: 12 weeks post-test ]
    Self rated questionnaire on quality of life with symptoms of Parkinson Disease

  5. Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 1 week post-test [ Time Frame: 1 week post-test ]
    A brief neuropsychological instrument designed to assess general cognitive functioning

  6. Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 4 weeks post-test [ Time Frame: 4 weeks post-test ]
    A brief neuropsychological instrument designed to assess general cognitive functioning

  7. Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 12 weeks post-test [ Time Frame: 12 weeks post-test ]
    A brief neuropsychological instrument designed to assess general cognitive functioning

  8. Raw score Change from baseline Zarit Burden Interview (12 items) to 3 weeks after the beginning of intervention [ Time Frame: 3 weeks after the beginning of intervention (mid-point) ]
    A 12-item questionnaire assessing the feeling of burden of the caregiver

  9. Raw score Change from baseline Zarit Burden Interview (12 items) to 1 week post-test [ Time Frame: 1 week post-test ]
    A 12-item questionnaire assessing the feeling of burden of the caregiver

  10. Raw score Change from baseline Zarit Burden Interview (12 items) to 4 weeks post-test [ Time Frame: 4 weeks post-test ]
    A 12-item questionnaire assessing the feeling of burden of the caregiver

  11. Raw score Change from baseline Zarit Burden Interview (12 items) to 12 week post-test [ Time Frame: 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

  12. Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 3 weeks after the beginning of intervention (mid-point) [ Time Frame: 3 weeks after the beginning of intervention (mid-point) ]
    assessment of twelve neuropsychiatric symptoms usually found in dementia

  13. Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test [ Time Frame: 1 week post-test ]
    assessment of twelve neuropsychiatric symptoms usually found in dementia

  14. Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test [ Time Frame: 4 week post-test ]
    assessment of twelve neuropsychiatric symptoms usually found in dementia

  15. Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test [ Time Frame: 12 week post-test ]
    assessment of twelve neuropsychiatric symptoms usually found in dementia

  16. Raw score Change from baseline Apathy Evaluation Scale (AES) to 3 weeks after the beginning of intervention (mid-point) [ Time Frame: 3 weeks after the beginning of intervention (mid-point) ]
    An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).

  17. Raw score Change from baseline Apathy Evaluation Scale (AES) to 1 week post-test [ Time Frame: 1 week post-test ]
    An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).

  18. Raw score Change from baseline Apathy Evaluation Scale (AES) to 4 weeks post-test [ Time Frame: 4 weeks post-test ]
    An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).

  19. Raw score Change from baseline Apathy Evaluation Scale (AES) to 12 weeks post-test [ Time Frame: 12 weeks post-test ]
    An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. PD diagnosis from the United Kingdom Research Brain Bank diagnostic criteria for PD (Hughes et al., 1992);
  2. 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);
  3. Montreal Cognitive Assessment scores between 21 and 27;
  4. Anti-Parkinson medication stable (at screening) since at least two months;
  5. All other medications, including psychotropics, stable for at least three months.

Exclusion Criteria:

  1. Participants with PD and dementia diagnosis
  2. Patients with other neurological or psychiatric disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636541


Locations
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Canada
School of Psychology
Québec, Canada, G1V0A6
Sponsors and Collaborators
Laval University
Investigators
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Study Director: Martine Simard Professor at Laval School of psychology
Publications of Results:
Other Publications:

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Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT04636541    
Other Study ID Numbers: AGiguère-Rancourt
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laval University:
Mild Cognitive Impairment
Parkinson Disease
Cognitive Intervention
Goal Management Training
Executive Functions
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders