The Effects of Mindfulness-based Cognitive Therapy in People With Parkinson's Disease

NCT05779137 | Active Not Recruiting DMC

• 1 other identifier: NL81309.091.22
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is a debilitating neurodegenerative disorder occurring in 7 million patients worldwide. PD is caused by progressive loss of nigro-striatal dopamine cells, which causes motor symptoms such as slowness of movement and tremor, and non-motor symptoms such as cognitive dysfunction. Converging clinical evidence indicates that PD patients are very sensitive to the effects of psychological stress. There is a high prevalence of stressrelated neuropsychiatric symptoms in PD: 30-40% of patients experience depression and 25-30% have anxiety. Furthermore, stress worsens many motor symptoms, e.g. tremor, freezing of gait, and dyskinesia. In addition to these immediate negative effects, chronic stress may also have detrimental long-term consequences, and specifically by accelerating disease progression, as suggested by animal models. However, this hypothesis remains to be confirmed in humans. Better evidence about the impact of stress on PD would have major treatment consequences: novel stress-reducing interventions may have symptomatic effects, and perhaps also disease-modifying effects. The aim of this study is to test whether a stress-reducing intervention improves clinical symptoms, slows neurodegeneration, and/or enhances neuroplasticity in PD. In a randomized controlled trial, the investigators will compare a stress-reducing mindfulness-based intervention group (MBI; one year) to a treatment as usual (TAU) group on clinical symptoms, cerebral markers of nigro-striatal dysfunction and stressor-reactivity (MRI), and inflammatory markers (serum).

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Mindfulness; Mindfulness-based cognitive therapy; Disease progression

Outcome Measures

Primary Outcomes (1)

• Psychological distress post-intervention (as assessed by HADS [0-42])

  Our primary outcome will be psychological distress (anxiety and depressive symptoms), measured by the Hospital Anxiety and Depression Scale (HADS) at T1 (post-intervention). The HADS is a validated self-report questionnaire consisting of anxiety and depression subscales, scores can range from 0-42 points. Lower scores mean less stress, i.e. better outcome. It was previously used as primary outcome measure in an MBCT-RCT in cancer, it was used as outcome measure in the largest MBI-RCT to date in PD, and it has been validated in PD. The effect on HADS will all be analyzed with an analysis of covariance (ANCOVA). The dependent variable will be the HADS score at T1; group allocation will serve as fixed factors, and age at T0, sex and the HADS score at T0 will serve as covariates.

  Month 2

Secondary Outcomes (25)

• Change in psychological distress (as assessed by HADS [0-42])

  Month 12. Change relative to baseline.

• Disease severity (as assessed by MDS-UPDRS [0-199])

  Month 0, month 2, month 12.

• Cognitive function (as assessed by MoCA [0-30])

  Month 0, month 2, month 12.

• Tremor severity (indicated by tremor power [log(µV2)])

  Month 0, month 2, month 12.

• Hair cortisol

  Month 0, month 2, month 12.

Study Arms (3)

Mindfulness based cognitive therapy (MBCT)

EXPERIMENTAL

62 patients will receive a mindfulness based intervention.

Behavioral: MBCT

Treatment as usual (TAU)

NO INTERVENTION

62 patients will receive treatment as usual, this will form a (passive) control group to the MBCT group.

Healthy control (HC)

NO INTERVENTION

50 healthy individuals without PD will not be randomized. This arm will only be measured once at baseline.

Interventions

MBCT BEHAVIORAL

Patients will join a mindfulness-based cognitive therapy course at the Radboudumc Center for Mindfulness. The course consists of eight weekly sessions of 2.5-hour and one 6-hour silence day between the 6th and 7th session. The sessions include meditation exercises (body-scan, sitting meditation, gentle movement exercises, three-minute breathing space, daily activities with attention), psychoeducation and group discussion. Psychoeducation includes information on cognitive techniques, like monitoring and scheduling of events and identification of negative automatic thoughts. In addition, all participants will be encouraged to perform daily practice assignments at home for about 30-45 minutes per day, mainly consisting of meditation exercises.

Mindfulness based cognitive therapy (MBCT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of idiopathic PD made by a movement disorders specialist.
• PD disease duration is ≤10 years, defined as time since diagnosis made by a neurologist.
• Mild-moderate symptoms of psychological distress (Hospital Anxiety and Depression Scale score \>10 points).
• Subject can read and understand the Dutch language.

You may not qualify if:

• Severe neurological or psychiatric co-morbidity (e.g. psychosis or suicidality).
• Contraindications for MRI (e.g. brain surgery in medical history, claustrophobia, an active implant, epilepsy, pregnancy, and/or metal objects in the upper body that are incompatible with MRI).
• Moderate to severe head tremor (to avoid artifacts caused by extensive head motion during scanning).
• Cognitive dysfunction (clinical diagnosis of dementia, or a score of 20 or lower on the MoCA, which will be measured at T0).
• Previous participation in MBSR or MBCT (\>4 sessions).
• Participants of the HC group must be able to read and understand the Dutch language.
• Severe neurological or psychiatric co-morbidity (e.g. psychosis or suicidality).
• Contraindications for MRI (e.g. brain surgery in medical history, claustrophobia, an active implant, epilepsy, pregnancy, and/or metal objects in the upper body that are incompatible with MRI).
• Cognitive dysfunction (clinical diagnosis of dementia, or a score of 20 or lower on the MoCA, which will be measured at T0).
• Detailed knowledge about the nature of the stress induction paradigm prior to participating in the study.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Donders Centre for Cognitive Neuroimaging

Nijmegen, 6525 EN, Netherlands

Location

Related Publications (9)

• Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.

  PMID: 33275908 BACKGROUND

• Kish SJ, Shannak K, Hornykiewicz O. Uneven pattern of dopamine loss in the striatum of patients with idiopathic Parkinson's disease. Pathophysiologic and clinical implications. N Engl J Med. 1988 Apr 7;318(14):876-80. doi: 10.1056/NEJM198804073181402.

  PMID: 3352672 BACKGROUND

• Hemmerle AM, Herman JP, Seroogy KB. Stress, depression and Parkinson's disease. Exp Neurol. 2012 Jan;233(1):79-86. doi: 10.1016/j.expneurol.2011.09.035. Epub 2011 Oct 6.

  PMID: 22001159 BACKGROUND

• van der Heide A, Speckens AEM, Meinders MJ, Rosenthal LS, Bloem BR, Helmich RC. Stress and mindfulness in Parkinson's disease - a survey in 5000 patients. NPJ Parkinsons Dis. 2021 Jan 18;7(1):7. doi: 10.1038/s41531-020-00152-9.

  PMID: 33462213 BACKGROUND

• de Pablos RM, Herrera AJ, Espinosa-Oliva AM, Sarmiento M, Munoz MF, Machado A, Venero JL. Chronic stress enhances microglia activation and exacerbates death of nigral dopaminergic neurons under conditions of inflammation. J Neuroinflammation. 2014 Feb 24;11:34. doi: 10.1186/1742-2094-11-34.

  PMID: 24565378 BACKGROUND

• Burtscher J, Copin JC, Rodrigues J, Kumar ST, Chiki A, Guillot de Suduiraut I, Sandi C, Lashuel HA. Chronic corticosterone aggravates behavioral and neuronal symptomatology in a mouse model of alpha-synuclein pathology. Neurobiol Aging. 2019 Nov;83:11-20. doi: 10.1016/j.neurobiolaging.2019.08.007. Epub 2019 Aug 14.

  PMID: 31585362 BACKGROUND

• van der Heide A, Meinders MJ, Speckens AEM, Peerbolte TF, Bloem BR, Helmich RC. Stress and Mindfulness in Parkinson's Disease: Clinical Effects and Potential Underlying Mechanisms. Mov Disord. 2021 Jan;36(1):64-70. doi: 10.1002/mds.28345. Epub 2020 Oct 23.

  PMID: 33094858 BACKGROUND

• Baer, R. A. Mindfulness training as a clinical intervention: a conceptual and empirical review. Clinical psychology: Science and practice 10, 125-143, doi:10.1093/clipsy.bpg015 (2003).

  BACKGROUND

• van der Heide A, Goltz F, de Vries NM, Bloem BR, Speckens AE, Helmich RC. Study protocol for the MIND-PD study: a randomized controlled trial to investigate clinical and biological effects of mindfulness-based cognitive therapy in people with Parkinson's disease. BMC Neurol. 2024 Jun 25;24(1):219. doi: 10.1186/s12883-024-03736-7.

  PMID: 38918695 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rick Helmich, MD PhD

  Radboud University Medical Centre; Donders Institute for Brain, Cognition and Behaviour

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The involved researchers will not be blinded to the treatment allocation, because this would not be feasible with the current design. Patients receiving MBCT need to be allocated to a specific treatment group, which requires extensive communication between the patient, mindfulness center and researcher. Also, patients receiving the treatment will perform different questionnaires in the course of the study, which makes it impossible for the researcher to be blinded for group allocation. We do not expect any bias on our primary outcome measure (self-report questionnaire). Secondary outcome measures (MRI, blood serum, hair cortisol) are unlikely to be biased by the researcher. UPDRS-III performance will be video recorded to allow blinded ratings by independent researchers after collecting the data (hence blinded outcome assessor). Patients will be informed about their intervention after randomization.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: March 22, 2023
• Study Start: April 17, 2023
• Primary Completion: March 13, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)