Goal Management Training for Parkinson Disease Mild Cognitive Impairment
NCT ID: NCT04636541
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2018-04-30
2019-07-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with other neurological or psychiatric disorders.
50 Years
80 Years
ALL
No
Sponsors
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Laval University
OTHER
Responsible Party
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Principal Investigators
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Martine Simard
Role: STUDY_DIRECTOR
Professor at Laval School of psychology
Locations
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School of Psychology
Québec, , Canada
Countries
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References
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Other Identifiers
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AGiguère-Rancourt
Identifier Type: -
Identifier Source: org_study_id