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Completed

NCT Number: NCT04636541

Goal Management Training for Parkinson Disease Mild Cognitive Impairment

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Psychology

Québec, G1V0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goal Management Training

Behavioral

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.

Psychoeducation

Behavioral

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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