Goal Management Training for Parkinson Disease Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Parkinson Disease

• 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

Study Timeline

• Study Start: 2018-04-30
• Primary Completion: 2019-07-20
• Study Completion: 2019-07-20
• Study First Submitted: 2020-10-30
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
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 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 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 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 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