Clinical trial NCT04636541: Goal Management Training for Parkinson Disease Mild Cognitive Impairment
Official title: Goal Management Training Home-Based Approach for Cognitive Impairment in Parkinson's Disease: A Single-Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Parkinson Disease
Cognitive Intervention
Goal Management Training
Executive Functions
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of two different cognitive intervention (two groups, randomized, single blinded)
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Raw score Change from baseline DEX (self rated) to 3 weeks after beginning of intervention
timeFrame: 3 weeks after beginning of intervention (mid-point)
measure: Raw score Change from baseline DEX (self rated) to 1 week post test
timeFrame: 1 week post-test
measure: Raw score Change from baseline DEX (self rated) to 4 weeks post test
timeFrame: 4 weeks post-test
measure: Raw score Change from baseline DEX (self rated) to 12 weeks post test
timeFrame: 12 weeks post-test
measure: Raw score Change from baseline DEX (caregiver rated) to 3 weeks after the beginning of intervention
timeFrame: 3 weeks after beginning of intervention (mid-point)
measure: Raw score Change from baseline DEX (caregiver rated) to 1 week post test
timeFrame: 1 week post-test
measure: Raw score Change from baseline DEX (caregiver rated) to 4 weeks post test
timeFrame: 4 weeks post-test
measure: Raw score Change from baseline DEX (caregiver rated) to 12 weeks post test
timeFrame: 12 weeks post-test
measure: Raw score Change from baseline Zoo Map Test to 1 week post test
timeFrame: 1 week post-test
measure: Raw score Change from baseline Zoo Map Test to 4 weeks post test
timeFrame: 4 weeks post-test
measure: Raw score Change from baseline Zoo Map Test to 12 weeks post test
timeFrame: 12 weeks post-test
Secondary outcomes:
measure: Raw score Change from baseline Parkinson Disease Questionnaire (39 items; PDQ-39) to 3 weeks after the beginning of intervention
timeFrame: 3 weeks after beginning of intervention (mid-point of intervention)
measure: Raw score Change from baseline PDQ-39 to 1 week post-test
timeFrame: 1 week post-test
measure: Raw score Change from baseline PDQ-39 to 4 weeks post-test
timeFrame: 4 weeks post-test
measure: Raw score Change from baseline PDQ-39 to 12 weeks post-test
timeFrame: 12 weeks post-test
measure: Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 1 week post-test
timeFrame: 1 week post-test
measure: Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 4 weeks post-test
timeFrame: 4 weeks post-test
measure: Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 12 weeks post-test
timeFrame: 12 weeks post-test
measure: Raw score Change from baseline Zarit Burden Interview (12 items) to 3 weeks after the beginning of intervention
timeFrame: 3 weeks after the beginning of intervention (mid-point)
measure: Raw score Change from baseline Zarit Burden Interview (12 items) to 1 week post-test
timeFrame: 1 week post-test
measure: Raw score Change from baseline Zarit Burden Interview (12 items) to 4 weeks post-test
timeFrame: 4 weeks post-test
measure: Raw score Change from baseline Zarit Burden Interview (12 items) to 12 week post-test
timeFrame: Baseline, mid-point of intervention, 1 week post-test, 4 weeks post-test and 12 weeks post-test
measure: Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 3 weeks after the beginning of intervention (mid-point)
timeFrame: 3 weeks after the beginning of intervention (mid-point)
measure: Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test
timeFrame: 1 week post-test
measure: Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test
timeFrame: 4 week post-test
measure: Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test
timeFrame: 12 week post-test
measure: Raw score Change from baseline Apathy Evaluation Scale (AES) to 3 weeks after the beginning of intervention (mid-point)
timeFrame: 3 weeks after the beginning of intervention (mid-point)
measure: Raw score Change from baseline Apathy Evaluation Scale (AES) to 1 week post-test
timeFrame: 1 week post-test
measure: Raw score Change from baseline Apathy Evaluation Scale (AES) to 4 weeks post-test
timeFrame: 4 weeks post-test
measure: Raw score Change from baseline Apathy Evaluation Scale (AES) to 12 weeks post-test
timeFrame: 12 weeks post-test
Other outcomes:
Locations:
city: Québec
country: Canada
facility: School of Psychology
Study officials:
affiliation: Professor at Laval School of psychology
name: Martine Simard
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Cummings 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.
citation: Dubois 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.
citation: Goldman 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.
citation: Grimes 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.
citation: Hindle 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.
citation: Hughes 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.
citation: Jenkinson 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.
citation: Litvan 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.
citation: Macht 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.
citation: Matteau 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.
citation: Roy 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.
citation: Stamenova 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.
citation: Vlagsma 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.
citation: Bora 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.
citation: Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
citation: Marin RS, Biedrzycki RC, Firinciogullari S. Reliability and validity of the Apathy Evaluation Scale. Psychiatry Res. 1991 Aug;38(2):143-62. doi: 10.1016/0165-1781(91)90040-v.
citation: Hiseman JP, Fackrell R. Caregiver Burden and the Nonmotor Symptoms of Parkinson's Disease. Int Rev Neurobiol. 2017;133:479-497. doi: 10.1016/bs.irn.2017.05.035. Epub 2017 Jul 21.
citation: Couture M, Giguere-Rancourt A, Simard M. The impact of cognitive interventions on cognitive symptoms in idiopathic Parkinson's disease: a systematic review. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2019 Sep;26(5):637-659. doi: 10.1080/13825585.2018.1513450. Epub 2018 Sep 17.
citation: Giguere-Rancourt A, Plourde M, Doiron M, Langlois M, Dupre N, Simard M. Goal management training (R) home-based approach for mild cognitive impairment in Parkinson's disease: a multiple baseline case report. Neurocase. 2018 Oct-Dec;24(5-6):276-286. doi: 10.1080/13554794.2019.1583345. Epub 2019 Mar 1.
citation: Giguere-Rancourt A, Plourde M, Racine E, Couture M, Langlois M, Dupre N, Simard M. Goal management training and psychoeducation / mindfulness for treatment of executive dysfunction in Parkinson's disease: A feasibility pilot trial. PLoS One. 2022 Feb 18;17(2):e0263108. doi: 10.1371/journal.pone.0263108. eCollection 2022.