Parkinson DiseaseNCT04636541
Goal Management Training for Parkinson Disease Mild Cognitive Impairment
A study testing Goal Management Training and Psychoeducation in people with Parkinson Disease and Mild Cognitive Impairment, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment
- What is being tested?
- Goal Management Training and Psychoeducation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2018to 20 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants with PD and dementia diagnosis
- Patients with other neurological or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Being tested
- Goal Management Training, Psychoeducation
- Keywords
- Mild Cognitive Impairment, Parkinson Disease, Cognitive Intervention, Goal Management Training, Executive Functions
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management TrainingBehavioural
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.
PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Goal Management Training | Experimental | 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. Receives: Behavioral: Goal Management Training |
| Psychoeducation sessions coupled mindfulness exercises | Active comparator | 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. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raw score Change from baseline DEX (self rated) to 3 weeks after beginning of intervention
Questionnaire on subjective executive functions
Measured: 3 weeks after beginning of intervention (mid-point)
Raw score Change from baseline DEX (self rated) to 1 week post test
Questionnaire on subjective executive functions
Measured: 1 week post-test
Raw score Change from baseline DEX (self rated) to 4 weeks post test
Questionnaire on subjective executive functions
Measured: 4 weeks post-test
Raw score Change from baseline DEX (self rated) to 12 weeks post test
Questionnaire on subjective executive functions
Measured: 12 weeks post-test
Raw score Change from baseline DEX (caregiver rated) to 3 weeks after the beginning of intervention
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Measured: 3 weeks after beginning of intervention (mid-point)
Raw score Change from baseline DEX (caregiver rated) to 1 week post test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Measured: 1 week post-test
Raw score Change from baseline DEX (caregiver rated) to 4 weeks post test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Measured: 4 weeks post-test
Raw score Change from baseline DEX (caregiver rated) to 12 weeks post test
Questionnaire on subjective executive functions (caregiver rates the executive functions of the participant
Measured: 12 weeks post-test
Raw score Change from baseline Zoo Map Test to 1 week post test
Neuropsychological test assessing planification and organisation
Measured: 1 week post-test
Raw score Change from baseline Zoo Map Test to 4 weeks post test
Neuropsychological test assessing planification and organisation
Measured: 4 weeks post-test
Raw score Change from baseline Zoo Map Test to 12 weeks post test
Neuropsychological test assessing planification and organisation
Measured: 12 weeks post-test
Secondary outcomes (19)
Raw score Change from baseline Parkinson Disease Questionnaire (39 items; PDQ-39) to 3 weeks after the beginning of intervention
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Measured: 3 weeks after beginning of intervention (mid-point of intervention)
Raw score Change from baseline PDQ-39 to 1 week post-test
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Measured: 1 week post-test
Raw score Change from baseline PDQ-39 to 4 weeks post-test
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Measured: 4 weeks post-test
Raw score Change from baseline PDQ-39 to 12 weeks post-test
Self rated questionnaire on quality of life with symptoms of Parkinson Disease
Measured: 12 weeks post-test
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 1 week post-test
A brief neuropsychological instrument designed to assess general cognitive functioning
Measured: 1 week post-test
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 4 weeks post-test
A brief neuropsychological instrument designed to assess general cognitive functioning
Measured: 4 weeks post-test
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 12 weeks post-test
A brief neuropsychological instrument designed to assess general cognitive functioning
Measured: 12 weeks post-test
Raw score Change from baseline Zarit Burden Interview (12 items) to 3 weeks after the beginning of intervention
A 12-item questionnaire assessing the feeling of burden of the caregiver
Measured: 3 weeks after the beginning of intervention (mid-point)
Raw score Change from baseline Zarit Burden Interview (12 items) to 1 week post-test
A 12-item questionnaire assessing the feeling of burden of the caregiver
Measured: 1 week post-test
Raw score Change from baseline Zarit Burden Interview (12 items) to 4 weeks post-test
A 12-item questionnaire assessing the feeling of burden of the caregiver
Measured: 4 weeks post-test
Raw score Change from baseline Zarit Burden Interview (12 items) to 12 week post-test
A 12-item questionnaire assessing the feeling of burden of the caregiver
Measured: 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)
assessment of twelve neuropsychiatric symptoms usually found in dementia
Measured: 3 weeks after the beginning of intervention (mid-point)
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test
assessment of twelve neuropsychiatric symptoms usually found in dementia
Measured: 1 week post-test
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test
assessment of twelve neuropsychiatric symptoms usually found in dementia
Measured: 4 week post-test
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test
assessment of twelve neuropsychiatric symptoms usually found in dementia
Measured: 12 week post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 3 weeks after the beginning of intervention (mid-point)
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Measured: 3 weeks after the beginning of intervention (mid-point)
Raw score Change from baseline Apathy Evaluation Scale (AES) to 1 week post-test
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Measured: 1 week post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 4 weeks post-test
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Measured: 4 weeks post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 12 weeks post-test
An 18-item questionnaire assessing different aspects of apathy (cognitive, behavioral and emotional).
Measured: 12 weeks post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start30 Apr 2018
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two different cognitive intervention (two groups, randomized, single blinded)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine Simard, Study director, Professor at Laval School of psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636541
- Sponsor's protocol ID
- AGiguère-Rancourt
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clare L, Teale JC, Toms G, Kudlicka A, Evans I, Abrahams S, Goldstein LH, Hindle JV, Ho AK, Jahanshahi M, Langdon D, Morris R, Snowden JS, Davies R, Markova I, Busse M, Thompson-Coon J. Cognitive rehabilitation, self-management, psychotherapeutic and caregiver support interventions in progressive neurodegenerative conditions: A scoping review. NeuroRehabilitation. 2018;43(4):443-471. doi: 10.3233/NRE-172353.
PubMed 30412509Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
PubMed 9153155Dubois B, Burn D, Goetz C, Aarsland D, Brown RG, Broe GA, Dickson D, Duyckaerts C, Cummings J, Gauthier S, Korczyn A, Lees A, Levy R, Litvan I, Mizuno Y, McKeith IG, Olanow CW, Poewe W, Sampaio C, Tolosa E, Emre M. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007 Dec;22(16):2314-24. doi: 10.1002/mds.21844.
PubMed 18098298Goldman JG, Vernaleo BA, Camicioli R, Dahodwala N, Dobkin RD, Ellis T, Galvin JE, Marras C, Edwards J, Fields J, Golden R, Karlawish J, Levin B, Shulman L, Smith G, Tangney C, Thomas CA, Troster AI, Uc EY, Coyan N, Ellman C, Ellman M, Hoffman C, Hoffman S, Simmonds D. Cognitive impairment in Parkinson's disease: a report from a multidisciplinary symposium on unmet needs and future directions to maintain cognitive health. NPJ Parkinsons Dis. 2018 Jun 26;4:19. doi: 10.1038/s41531-018-0055-3. eCollection 2018.
PubMed 29951580Grimes D, Gordon J, Snelgrove B, Lim-Carter I, Fon E, Martin W, Wieler M, Suchowersky O, Rajput A, Lafontaine AL, Stoessl J, Moro E, Schoffer K, Miyasaki J, Hobson D, Mahmoudi M, Fox S, Postuma R, Kumar H, Jog M; Canadian Nourological Sciences Federation. Canadian Guidelines on Parkinson's Disease. Can J Neurol Sci. 2012 Jul;39(4 Suppl 4):S1-30. doi: 10.1017/s031716710001516x. No abstract available.
PubMed 23126020Hindle JV, Watermeyer TJ, Roberts J, Brand A, Hoare Z, Martyr A, Clare L. Goal-orientated cognitive rehabilitation for dementias associated with Parkinson's disease-A pilot randomised controlled trial. Int J Geriatr Psychiatry. 2018 May;33(5):718-728. doi: 10.1002/gps.4845. Epub 2018 Jan 4.
PubMed 29314218Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.
PubMed 1564476Jenkinson C, Peto V, Fitzpatrick R, Greenhall R, Hyman N. Self-reported functioning and well-being in patients with Parkinson's disease: comparison of the short-form health survey (SF-36) and the Parkinson's Disease Questionnaire (PDQ-39). Age Ageing. 1995 Nov;24(6):505-9. doi: 10.1093/ageing/24.6.505.
PubMed 8588541Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.
PubMed 22275317Macht M, Gerlich C, Ellgring H, Schradi M, Rusinol AB, Crespo M, Prats A, Viemero V, Lankinen A, Bitti PE, Candini L, Spliethoff-Kamminga N, de Vreugd J, Simons G, Pasqualini MS, Thompson SB, Taba P, Krikmann U, Kanarik E. Patient education in Parkinson's disease: Formative evaluation of a standardized programme in seven European countries. Patient Educ Couns. 2007 Feb;65(2):245-52. doi: 10.1016/j.pec.2006.08.005. Epub 2006 Sep 11.
PubMed 16965885Matteau E, Dupre N, Langlois M, Provencher P, Simard M. Clinical validity of the Mattis Dementia Rating Scale-2 in Parkinson disease with MCI and dementia. J Geriatr Psychiatry Neurol. 2012 Jun;25(2):100-6. doi: 10.1177/0891988712445086.
PubMed 22689702Roy MA, Doiron M, Talon-Croteau J, Dupre N, Simard M. Effects of Antiparkinson Medication on Cognition in Parkinson's Disease: A Systematic Review. Can J Neurol Sci. 2018 Jul;45(4):375-404. doi: 10.1017/cjn.2018.21. Epub 2018 May 11.
PubMed 29747716Stamenova V, Levine B. Effectiveness of goal management training(R) in improving executive functions: A meta-analysis. Neuropsychol Rehabil. 2019 Dec;29(10):1569-1599. doi: 10.1080/09602011.2018.1438294. Epub 2018 Mar 14.
PubMed 29540124Vlagsma TT, Koerts J, Fasotti L, Tucha O, van Laar T, Dijkstra H, Spikman JM. Parkinson's patients' executive profile and goals they set for improvement: Why is cognitive rehabilitation not common practice? Neuropsychol Rehabil. 2016;26(2):216-35. doi: 10.1080/09602011.2015.1013138. Epub 2015 Feb 19.
PubMed 25693688Bora E, Walterfang M, Velakoulis D. Theory of mind in Parkinson's disease: A meta-analysis. Behav Brain Res. 2015 Oct 1;292:515-20. doi: 10.1016/j.bbr.2015.07.012. Epub 2015 Jul 9.
PubMed 26166188
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Management Training Home-Based Approach for Cognitive Impairment in Parkinson's Disease: A Single-Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT04636541
- Acronym / sponsor ID
- AGiguère-Rancourt
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Parkinson Disease, Cognitive Intervention, Goal Management Training, Executive Functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of two different cognitive intervention (two groups, randomized, single blinded)
| Arm | Type | Receives |
|---|---|---|
| Goal Management Training | Experimental | Behavioral: Goal Management TrainingGMT 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. |
| Psychoeducation sessions coupled mindfulness exercises | Active comparator | Behavioral: PsychoeducationFive 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants with PD and dementia diagnosis
- Patients with other neurological or psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Management TrainingGoal 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. | Behavioural | Goal Management Training |
| PsychoeducationSee 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. | Behavioural | Psychoeducation sessions coupled mindfulness exercises |
Primary outcome
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
Raw score Change from baseline DEX (self rated) to 1 week post test
Time frame: 1 week post-test
Questionnaire on subjective executive functions
Raw score Change from baseline DEX (self rated) to 4 weeks post test
Time frame: 4 weeks post-test
Questionnaire on subjective executive functions
Raw score Change from baseline DEX (self rated) to 12 weeks post test
Time frame: 12 weeks post-test
Questionnaire on subjective executive functions
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
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
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
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
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
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
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
19 secondary outcomes
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)
Raw score Change from baseline PDQ-39 to 1 week post-test
Time frame: 1 week post-test
Raw score Change from baseline PDQ-39 to 4 weeks post-test
Time frame: 4 weeks post-test
Raw score Change from baseline PDQ-39 to 12 weeks post-test
Time frame: 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
Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 4 weeks post-test
Time frame: 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
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)
Raw score Change from baseline Zarit Burden Interview (12 items) to 1 week post-test
Time frame: 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
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
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)
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test
Time frame: 1 week post-test
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test
Time frame: 4 week post-test
Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test
Time frame: 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)
Raw score Change from baseline Apathy Evaluation Scale (AES) to 1 week post-test
Time frame: 1 week post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 4 weeks post-test
Time frame: 4 weeks post-test
Raw score Change from baseline Apathy Evaluation Scale (AES) to 12 weeks post-test
Time frame: 12 weeks post-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Background: PubMed 30412509Clare L, Teale JC, Toms G, Kudlicka A, Evans I, Abrahams S, Goldstein LH, Hindle JV, Ho AK, Jahanshahi M, Langdon D, Morris R, Snowden JS, Davies R, Markova I, Busse M, Thompson-Coon J. Cognitive rehabilitation, self-management, psychotherapeutic and caregiver support interventions in progressive neurodegenerative conditions: A scoping review. NeuroRehabilitation. 2018;43(4):443-471. doi: 10.3233/NRE-172353.
- Background: PubMed 9153155Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
- Background: PubMed 18098298Dubois B, Burn D, Goetz C, Aarsland D, Brown RG, Broe GA, Dickson D, Duyckaerts C, Cummings J, Gauthier S, Korczyn A, Lees A, Levy R, Litvan I, Mizuno Y, McKeith IG, Olanow CW, Poewe W, Sampaio C, Tolosa E, Emre M. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007 Dec;22(16):2314-24. doi: 10.1002/mds.21844.
- Background: PubMed 29951580Goldman JG, Vernaleo BA, Camicioli R, Dahodwala N, Dobkin RD, Ellis T, Galvin JE, Marras C, Edwards J, Fields J, Golden R, Karlawish J, Levin B, Shulman L, Smith G, Tangney C, Thomas CA, Troster AI, Uc EY, Coyan N, Ellman C, Ellman M, Hoffman C, Hoffman S, Simmonds D. Cognitive impairment in Parkinson's disease: a report from a multidisciplinary symposium on unmet needs and future directions to maintain cognitive health. NPJ Parkinsons Dis. 2018 Jun 26;4:19. doi: 10.1038/s41531-018-0055-3. eCollection 2018.
- Background: PubMed 23126020Grimes D, Gordon J, Snelgrove B, Lim-Carter I, Fon E, Martin W, Wieler M, Suchowersky O, Rajput A, Lafontaine AL, Stoessl J, Moro E, Schoffer K, Miyasaki J, Hobson D, Mahmoudi M, Fox S, Postuma R, Kumar H, Jog M; Canadian Nourological Sciences Federation. Canadian Guidelines on Parkinson's Disease. Can J Neurol Sci. 2012 Jul;39(4 Suppl 4):S1-30. doi: 10.1017/s031716710001516x. No abstract available.
- Background: PubMed 29314218Hindle JV, Watermeyer TJ, Roberts J, Brand A, Hoare Z, Martyr A, Clare L. Goal-orientated cognitive rehabilitation for dementias associated with Parkinson's disease-A pilot randomised controlled trial. Int J Geriatr Psychiatry. 2018 May;33(5):718-728. doi: 10.1002/gps.4845. Epub 2018 Jan 4.
- Background: PubMed 1564476Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.
- Background: PubMed 8588541Jenkinson C, Peto V, Fitzpatrick R, Greenhall R, Hyman N. Self-reported functioning and well-being in patients with Parkinson's disease: comparison of the short-form health survey (SF-36) and the Parkinson's Disease Questionnaire (PDQ-39). Age Ageing. 1995 Nov;24(6):505-9. doi: 10.1093/ageing/24.6.505.
- Background: PubMed 22275317Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.
- Background: PubMed 16965885Macht M, Gerlich C, Ellgring H, Schradi M, Rusinol AB, Crespo M, Prats A, Viemero V, Lankinen A, Bitti PE, Candini L, Spliethoff-Kamminga N, de Vreugd J, Simons G, Pasqualini MS, Thompson SB, Taba P, Krikmann U, Kanarik E. Patient education in Parkinson's disease: Formative evaluation of a standardized programme in seven European countries. Patient Educ Couns. 2007 Feb;65(2):245-52. doi: 10.1016/j.pec.2006.08.005. Epub 2006 Sep 11.
- Background: PubMed 22689702Matteau E, Dupre N, Langlois M, Provencher P, Simard M. Clinical validity of the Mattis Dementia Rating Scale-2 in Parkinson disease with MCI and dementia. J Geriatr Psychiatry Neurol. 2012 Jun;25(2):100-6. doi: 10.1177/0891988712445086.
- Background: PubMed 29747716Roy MA, Doiron M, Talon-Croteau J, Dupre N, Simard M. Effects of Antiparkinson Medication on Cognition in Parkinson's Disease: A Systematic Review. Can J Neurol Sci. 2018 Jul;45(4):375-404. doi: 10.1017/cjn.2018.21. Epub 2018 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Simard study director
Professor at Laval School of psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training and Psychoeducation in people with Parkinson Disease and Mild Cognitive Impairment, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636541, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.