Goal Management Training for Parkinson Disease Mild Cognitive Impairment

NCT04636541 | Completed

• 1 other identifier: AGiguère-Rancourt
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Parkinson Disease; Cognitive Intervention; Goal Management Training; Executive Functions

Outcome Measures

Primary Outcomes (11)

• Raw score Change from baseline DEX (self rated) to 3 weeks after beginning of intervention

  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

  Questionnaire on subjective executive functions

  1 week post-test

• Raw score Change from baseline DEX (self rated) to 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

  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

  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

  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

  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

  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

  Neuropsychological test assessing planification and organisation

  1 week post-test

• Raw score Change from baseline Zoo Map Test to 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

  Neuropsychological test assessing planification and organisation

  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

  3 weeks after beginning of intervention (mid-point of intervention)

• Raw score Change from baseline PDQ-39 to 1 week post-test

  1 week post-test

• Raw score Change from baseline PDQ-39 to 4 weeks post-test

  4 weeks post-test

• Raw score Change from baseline PDQ-39 to 12 weeks post-test

  12 weeks post-test

• Mean Change from baseline Dementia Rating Scale, 2nd edition (DRS-II) to 1 week post-test

  1 week post-test

Study Arms (2)

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.

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.

Behavioral: Psychoeducation

Interventions

Goal Management Training BEHAVIORAL

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.

Goal Management Training

Psychoeducation BEHAVIORAL

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.

Psychoeducation sessions coupled mindfulness exercises

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants with PD and dementia diagnosis
• Patients with other neurological or psychiatric disorders.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

School of Psychology

Québec, G1V0A6, Canada

Location

Related Publications (21)

• 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.

  PMID: 30412509 BACKGROUND

• 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.

  PMID: 9153155 BACKGROUND

• 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.

  PMID: 18098298 BACKGROUND

• 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.

  PMID: 29951580 BACKGROUND

• 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.

  PMID: 23126020 BACKGROUND

• 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.

  PMID: 29314218 BACKGROUND

• 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.

  PMID: 1564476 BACKGROUND

• 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.

  PMID: 8588541 BACKGROUND

• 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.

  PMID: 22275317 BACKGROUND

• 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.

  PMID: 16965885 BACKGROUND

• 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.

  PMID: 22689702 BACKGROUND

• 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.

  PMID: 29747716 BACKGROUND

• 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.

  PMID: 29540124 BACKGROUND

• 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.

  PMID: 25693688 BACKGROUND

• 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.

  PMID: 26166188 BACKGROUND

• 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.

  PMID: 11574710 BACKGROUND

• 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.

  PMID: 1754629 BACKGROUND

• 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.

  PMID: 28802929 BACKGROUND

• 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.

  PMID: 30221586 RESULT

• 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.

  PMID: 30821637 RESULT

• 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.

  PMID: 35180229 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Martine Simard

  Professor at Laval School of psychology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The research was a single blind randomized comparative study. After the screening evaluation, participants were randomly assigned to either group A or B, described below (block randomization, three blocks of four participants).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of two different cognitive intervention (two groups, randomized, single blinded)

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 19, 2020
• Study Start: April 30, 2018
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)