Goal Management Training for Parkinson Disease Mild Cognitive Impairment

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636541
• Other study ID #: AGiguère-Rancourt
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: November 2020
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	School of Psychology	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (20)

Bédard 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. — View 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. Review. — View 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. — View Citation

Couture M, Giguère-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: 10.1080/13825585.201 — View Citation

Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. Review. — View 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. Review. — View Citation

Giguère-Rancourt A, Plourde M, Doiron M, Langlois M, Dupré N, Simard M. Goal management training ® 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: 1 — View 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, Tröster 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Litvan I, Goldman JG, Tröster 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. Review. — View Citation

Macht M, Gerlich C, Ellgring H, Schradi M, Rusiñol AB, Crespo M, Prats A, Viemerö 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. Epub 2006 Sep 11. — View Citation

Marin RS, Biedrzycki RC, Firinciogullari S. Reliability and validity of the Apathy Evaluation Scale. Psychiatry Res. 1991 Aug;38(2):143-62. — View Citation

Matteau E, Dupré 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. — View Citation

Roy MA, Doiron M, Talon-Croteau J, Dupré 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. — View Citation

Stamenova V, Levine B. Effectiveness of goal management training® 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. Review. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Raw score Change from baseline DEX (self rated) to 1 week post test	Questionnaire on subjective executive functions	1 week post-test
Primary	Raw score Change from baseline DEX (self rated) to 4 weeks post test	Questionnaire on subjective executive functions	4 weeks post-test
Primary	Raw score Change from baseline DEX (self rated) to 12 weeks post test	Questionnaire on subjective executive functions	12 weeks post-test
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	Raw score Change from baseline Zoo Map Test to 1 week post test	Neuropsychological test assessing planification and organisation	1 week post-test
Primary	Raw score Change from baseline Zoo Map Test to 4 weeks post test	Neuropsychological test assessing planification and organisation	4 weeks post-test
Primary	Raw score Change from baseline Zoo Map Test to 12 weeks post test	Neuropsychological test assessing planification and organisation	12 weeks post-test
Secondary	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	3 weeks after beginning of intervention (mid-point of intervention)
Secondary	Raw score Change from baseline PDQ-39 to 1 week post-test	Self rated questionnaire on quality of life with symptoms of Parkinson Disease	1 week post-test
Secondary	Raw score Change from baseline PDQ-39 to 4 weeks post-test	Self rated questionnaire on quality of life with symptoms of Parkinson Disease	4 weeks post-test
Secondary	Raw score Change from baseline PDQ-39 to 12 weeks post-test	Self rated questionnaire on quality of life with symptoms of Parkinson Disease	12 weeks post-test
Secondary	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	1 week post-test
Secondary	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	4 weeks post-test
Secondary	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	12 weeks post-test
Secondary	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	3 weeks after the beginning of intervention (mid-point)
Secondary	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	1 week post-test
Secondary	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	4 weeks post-test
Secondary	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	Baseline, mid-point of intervention, 1 week post-test, 4 weeks post-test and 12 weeks post-test
Secondary	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	3 weeks after the beginning of intervention (mid-point)
Secondary	Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 1 week post-test	assessment of twelve neuropsychiatric symptoms usually found in dementia	1 week post-test
Secondary	Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 4 weeks post-test	assessment of twelve neuropsychiatric symptoms usually found in dementia	4 week post-test
Secondary	Raw score Change from baseline Neuropsychiatric Inventory, 12 items to 12 weeks post-test	assessment of twelve neuropsychiatric symptoms usually found in dementia	12 week post-test
Secondary	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).	3 weeks after the beginning of intervention (mid-point)
Secondary	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).	1 week post-test
Secondary	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).	4 weeks post-test
Secondary	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).	12 weeks post-test