Goal Management Training for Parkinson Disease Mild Cognitive Impairment

November 16, 2020 updated by: Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V0A6
        • School of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks after beginning of intervention (mid-point)
Raw score Change from baseline DEX (self rated) to 1 week post test
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 3 weeks after beginning of intervention (mid-point)
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 3 weeks after beginning of intervention (mid-point 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 3 weeks after the beginning of intervention (mid-point)
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
Time Frame: 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
Time Frame: 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
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
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)
Time Frame: 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
Time Frame: 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
Time Frame: 4 week 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
Time Frame: 12 week 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 12 weeks post-test
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
12 weeks post-test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Study Director: Martine Simard, Professor at Laval School of psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2018

Primary Completion (ACTUAL)

July 20, 2019

Study Completion (ACTUAL)

July 20, 2019

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (ACTUAL)

November 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGiguère-Rancourt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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