Parkinson's DiseaseMIND-PDNCT05779137
The Effects of Mindfulness-based Cognitive Therapy in People With Parkinson's Disease
A study testing MBCT in people with Parkinson's Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- MBCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Apr 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- Participants of the HC group must be able to read and understand the Dutch language.
Who cannot join
- 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).
- Severe neurological or psychiatric co-morbidity (e.g. psychosis or suicidality).
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Donders Centre for Cognitive Neuroimaging
Nijmegen, 6525 EN
About this study
Official title: The Effect of Mindfulness-based Cognitive Therapy on Psychological Distress in People With Parkinson's Disease
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).
Read the detailed description
Parkinson's disease (PD) is a common and fast-growing neurological disease, clinically characterized by motor slowing (bradykinesia), stiffness (rigidity) and resting tremor. The pathological hallmark of PD is nigro-striatal dopamine depletion, but the noradrenergic (stress) system is also affected. Indeed, the prevalence of stress-related neuropsychiatric symptoms in PD is high and many PD patients suffer from reduced health-related quality of life. Also, (chronic) stress worsens many motor symptoms and may have detrimental long-term consequences by accelerating disease progression, as suggested by animal models.
There is no cure for PD, and currently no treatments to slow down disease progression. Therefore, the development of new and effective treatments is crucial. Given the large role of stress on PD symptoms, stress reduction might improve motor as well as non-motor symptoms. Intriguingly, recent evidence suggests that mindfulness training, where mindfulness is the trainable capacity to experience the present moment on purpose and without judgment, is an effective way to achieve such stress reduction. In fact, the effects of mindfulness practice have gained much interest as a topic of scientific research and clinical practise recently, where Mindfulness-Based Cognitive Therapy (MBCT) is one of the most commonly applied interventions, shown to be effective for a variety of somatic and psychiatric disorders. Importantly, previous trials investigating the effect of mindfulness-based interventions (MBIs) on clinical symptoms in PD showed positive effects on depression in 6/8 trials, on anxiety in 4/7 trials and on motor symptoms in 2/3 studies. Also, a large online survey on patients' experiences with stress and mindfulness showed that on one hand, patients experienced considerably more stress than controls, and significant stress-related worsening of PD symptoms; on the other, PD mindfulness users reported positive effects of mindfulness on anxiety and depression. In summary, current evidence suggests a positive effect of MBIs on psychological distress in PD, but clinical evidence is inconclusive. Also, to date, there is no research on the (cerebral) mechanisms underlying the (positive) effects of mindfulness in PD. Insight to the cerebral mechanisms of MBIs can pave the way for developing new, mechanism-based interventions, and can help to uncover the nature of the effects of stress on Parkinson's disease. Specifically, a mechanism based approach allows us to disentangle the symptomatic (stress as an amplifying factor on motor dysfunction) as opposed to neurodegenerative (nigro-striatal cell loss) effects of stress.
In this study, the investigators will test the effect of MBCT on the clinical (symptomatic) and neurodegenerative course of PD. If proven to be effective, MBCT can be applied as a new and cost-effective therapy to PD patients. The investigators will perform a randomized controlled trial with MBCT as intervention and a treatment as usual (TAU) control group. The investigators will evaluate whether a MBCT mindfulness course can lead to clinically relevant reductions in psychological distress (measured with the Hamilton Anxiety and Depression Scale) in PD patients with mild to moderate symptoms of psychological distress. Also, the investigators will evaluate the effects of a MBCT mindfulness course on other PD symptoms (e.g. motor dysfunction), cerebral markers of neurodegeneration, and neuroplasticity, and explore whether the intervention lowers systemic inflammatory tone in PD. The total duration of data acquisition per participant will be 12 months, consisting of a baseline measurement (T0), an intervention period of 2 months followed by a post-measurement (T1), and a final measurement (T2) that takes place 12 months after T0.
- Conditions
- Parkinson's Disease
- Being tested
- MBCT
- Keywords
- Parkinson's Disease, Mindfulness, Mindfulness-based cognitive therapy, Disease progression
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based cognitive therapy (MBCT) | Experimental | 62 patients will receive a mindfulness based intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 2
Secondary outcomes (25)
Change in psychological distress (as assessed by HADS [0-42])
HADS [0-42] (lower score = better (less stress), see also primary outcome.
Measured: Month 12. Change relative to baseline.
Disease severity (as assessed by MDS-UPDRS [0-199])
MDS-UPDRS [0-199] (higher score = worse (more disability)). We will assess overall symptom severity as a function of time T0/T1/T2 and group (MBCT vs. TAU).
Measured: Month 0, month 2, month 12.
Cognitive function (as assessed by MoCA [0-30])
Montreal Cognitive Assessment; MoCA [0-30] (higher score = better (less disability)) We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 12.
Tremor severity (indicated by tremor power [log(µV2)])
We will compare tremor severity as measured with accelerometry during rest, mental arithmetic (coco), posturing and action. We will perform a 2x2x2 ANOVA with between-subjects factor GROUP (MBCT vs. control), and within-subjects factors TIME (T0 vs. T2) and CONDITION (coco vs. rest, posture vs. rest, action vs. rest).
Measured: Month 0, month 2, month 12.
Hair cortisol
Hair cortisol levels will be established by means of a hair sample and hair cortisol concentration of the previous 2 months will be assessed and compared between T0/T1/T2 and between groups (MBCT/TAU)
Measured: Month 0, month 2, month 12.
Bradykinesia severity (indicated by average keys per second on key tapping test)
We will measure bradykinesia severity by means of a keyboard finger tapping test. Average keys pressed per seconds will be used as dependent variable. More keys per second = less disability. We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 12.
Inflammatory tone (as assessed by serum C-reactive protein)
We will be assessing inflammatory tone by means of serum C-reactie protein (CRP) levels. Higher CRP = more inflammation.
Measured: Month 0, month 2, month 12.
Quality of life questionnaire (as assessed by PDQ-39 [0-100])
Parkinson Disease Questionnaire 39; PDQ-39 [0 - 100] (higher score = worse (more disability)) We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 6, month 12.
Perceived stress (as assessed by PSS [0-40])
Perceived Stress Scale; PSS [0 - 40] (higher score = worse (more perceived stress)) We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 6, month 12.
Rumination (as assessed by RRS [26-104])
Ruminative Response Scale; RRS [26-104] (higher score = worse (more ruminative thoughts)) We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 6, month 12.
Mindfulness skills (as assessed by FFMQ [39-195])
Five Facet Mindfulness Questionnaire Short Form; FFMQ [39-195] (higher score = better (more mindfulness skills)) We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 6, month 12.
Self-compassion as assessed by SCS [12-84])
Self-Compassion Short Form; SCS [12-84] (higher score = better (more self compassion)) We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 6, month 12.
Self-efficacy (as assessed by GSES [10-40])
General Self-Efficacy Scale; GSES [10-40] (higher score = better (more self efficacy)) We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 6, month 12.
Positive appraisal (as assessed by PASS)
Positive Appraisal Style Scale; PASS [for each coping style: 2-10, for humor: 1-8] We will test whether clinical scores change significantly between T0, T1 and T2 using mixed models.
Measured: Month 0, month 2, month 6, month 12.
Decision making task
Patients will perform a neuropsychological task designed to track individual decision making and learning processes. Computational modeling will be used to model response patters according to an actor model and a spectator model. Response patterns will be compared as a function of group (MBCT / TAU) and time (T0 / T1/ T2).
Measured: Month 0, month 2, month 12.
Salivary cortisol
Acute cortisol levels will be assessed via saliva samples during socially evaluated cold pressor test as a function of group (MBCT/TAU), time (T0/T2), and SECPT time points (pre/post/30mpost/60mpost).
Measured: Month 0, month 12.
Resting state network reactivity to a stressor (fMRI)
Resting-state network connectivity will be assessed based on resting state fMRI before and after the socially evaluated cold pressure test (SECPT). In specific, this will be evaluated as a function of group (MBCT / TAU), time (T0 / T2), and SECPT (before / after). Resting state networks of interest include the salience network, central executive network, and default mode network.
Measured: Month 0, month 12.
Grey matter volume of stress-related regions (MRI)
By means of a structural T1 scan, we will compare structural changes in stress-related brain regions, e.g. amygdala, hippocampus. Specifically, grey matter volume will be compared as a function of group (MBCT / TAU) and time (T0 / T2).
This measure will help us distinguish between structural changes versus network adaptations as a response to the intervention.
Measured: Month 0, month 12.
Structural integrity of substantia nigra and locus coeruleus (LC)
To further evaluate structural integrity of the substantia nigra and LC, signal intensity on neuromelanin sensitive MRI scans, as well as diffusion MRI will be determined before and one year after the MBI. Structural integrity will be analysed as a function of group (MBCT / TAU) and time (T0 / T2).
Measured: Month 0, month 12.
Functional integrity of nigro-striatal dopamine system
To quantify the functional integrity of the nigro-striatal dopamine system, we will use resting-state fMRI to calculate gradients of cortico-striatal connectivity. This fMRI measure is sensitive to compensatory changes: in PD, cortico-striatal connectivity shifts from more-affected (posterior) to less-affected (anterior) portions of the striatum. To investigate this, functional connectivity profiles of the posterior and anterior putamen specifically will be determined and analysed as a function of group (MBCT / TAU) and time (T0 / T2).
Measured: Month 0, month 12.
Hair cortisol (HC)
Hair cortisol levels will be established by means of a scalp hair sample. Hair cortisol concentration of the previous 3 months will be assessed and compared between groups (PD/HC).
Measured: Month 0
Decision making task (HC)
Patients will perform a neuropsychological task designed to track individual decision making and learning processes. Computational modeling will be used to model response patterns according to an actor model and a spectator model. Response patterns will be compared as a function of group (PD/HC).
Measured: Month 0
Salivary cortisol (HC)
Acute cortisol levels will be assessed via saliva samples during socially evaluated cold pressor test as a function of group (PD/HC) and SECPT time points (pre/post/30mpost/60mpost).
Measured: Month 0
Resting state network reactivity to a stressor (fMRI) (HC)
Resting-state network connectivity will be assessed based on resting state fMRI before and after the socially evaluated cold pressor test (SECPT). In specific, this will be evaluated as a function of group (PD/ HC) and SECPT (before / after). Resting state networks of interest include the salience network, central executive network, and default mode network. Relevant mediators of the effect will be explored.
Measured: Month 0
Structural integrity of substantia nigra and locus coeruleus (HC)
To evaluate structural integrity of the substantia nigra and locus coeruleus, signal intensity on neuromelanin sensitive MRI scans, as well as diffusion MRI will be determined. Structural integrity will be analysed as a function of group (PD/ HC).
Measured: Month 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start17 Apr 2023
- Primary completion13 Mar 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rick Helmich, MD PhD, Principal investigator, Radboud University Medical Centre; Donders Institute for Brain, Cognition and Behaviour
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779137
- Sponsor's protocol ID
- NL81309.091.22
- Acronym
- MIND-PD
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33275908Kish 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.
PubMed 3352672Hemmerle 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.
PubMed 22001159van 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.
PubMed 33462213de 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.
PubMed 24565378Burtscher 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.
PubMed 31585362van 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.
PubMed 33094858Baer, 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).
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.
PubMed 38918695
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-based Cognitive Therapy on Psychological Distress in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05779137
- Acronym / sponsor ID
- MIND-PD / NL81309.091.22
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Mindfulness, Mindfulness-based cognitive therapy, Disease progression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Mar 2023 (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.
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).
Detailed description
Parkinson's disease (PD) is a common and fast-growing neurological disease, clinically characterized by motor slowing (bradykinesia), stiffness (rigidity) and resting tremor. The pathological hallmark of PD is nigro-striatal dopamine depletion, but the noradrenergic (stress) system is also affected. Indeed, the prevalence of stress-related neuropsychiatric symptoms in PD is high and many PD patients suffer from reduced health-related quality of life. Also, (chronic) stress worsens many motor symptoms and may have detrimental long-term consequences by accelerating disease progression, as suggested by animal models.
There is no cure for PD, and currently no treatments to slow down disease progression. Therefore, the development of new and effective treatments is crucial. Given the large role of stress on PD symptoms, stress reduction might improve motor as well as non-motor symptoms. Intriguingly, recent evidence suggests that mindfulness training, where mindfulness is the trainable capacity to experience the present moment on purpose and without judgment, is an effective way to achieve such stress reduction. In fact, the effects of mindfulness practice have gained much interest as a topic of scientific research and clinical practise recently, where Mindfulness-Based Cognitive Therapy (MBCT) is one of the most commonly applied interventions, shown to be effective for a variety of somatic and psychiatric disorders. Importantly, previous trials investigating the effect of mindfulness-based interventions (MBIs) on clinical symptoms in PD showed positive effects on depression in 6/8 trials, on anxiety in 4/7 trials and on motor symptoms in 2/3 studies. Also, a large online survey on patients' experiences with stress and mindfulness showed that on one hand, patients experienced considerably more stress than controls, and significant stress-related worsening of PD symptoms; on the other, PD mindfulness users reported positive effects of mindfulness on anxiety and depression. In summary, current evidence suggests a positive effect of MBIs on psychological distress in PD, but clinical evidence is inconclusive. Also, to date, there is no research on the (cerebral) mechanisms underlying the (positive) effects of mindfulness in PD. Insight to the cerebral mechanisms of MBIs can pave the way for developing new, mechanism-based interventions, and can help to uncover the nature of the effects of stress on Parkinson's disease. Specifically, a mechanism based approach allows us to disentangle the symptomatic (stress as an amplifying factor on motor dysfunction) as opposed to neurodegenerative (nigro-striatal cell loss) effects of stress.
In this study, the investigators will test the effect of MBCT on the clinical (symptomatic) and neurodegenerative course of PD. If proven to be effective, MBCT can be applied as a new and cost-effective therapy to PD patients. The investigators will perform a randomized controlled trial with MBCT as intervention and a treatment as usual (TAU) control group. The investigators will evaluate whether a MBCT mindfulness course can lead to clinically relevant reductions in psychological distress (measured with the Hamilton Anxiety and Depression Scale) in PD patients with mild to moderate symptoms of psychological distress. Also, the investigators will evaluate the effects of a MBCT mindfulness course on other PD symptoms (e.g. motor dysfunction), cerebral markers of neurodegeneration, and neuroplasticity, and explore whether the intervention lowers systemic inflammatory tone in PD. The total duration of data acquisition per participant will be 12 months, consisting of a baseline measurement (T0), an intervention period of 2 months followed by a post-measurement (T1), and a final measurement (T2) that takes place 12 months after T0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based cognitive therapy (MBCT) | Experimental | Behavioral: MBCT62 patients will receive a mindfulness based intervention. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Participants of the HC group must be able to read and understand the Dutch language.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| MBCTPatients 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. | Behavioural | Mindfulness based cognitive therapy (MBCT) |
Primary outcome
Psychological distress post-intervention (as assessed by HADS [0-42])
Time frame: Month 2
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.
25 secondary outcomes
Change in psychological distress (as assessed by HADS [0-42])
Time frame: Month 12. Change relative to baseline.
Disease severity (as assessed by MDS-UPDRS [0-199])
Time frame: Month 0, month 2, month 12.
Cognitive function (as assessed by MoCA [0-30])
Time frame: Month 0, month 2, month 12.
Tremor severity (indicated by tremor power [log(µV2)])
Time frame: Month 0, month 2, month 12.
Hair cortisol
Time frame: Month 0, month 2, month 12.
Bradykinesia severity (indicated by average keys per second on key tapping test)
Time frame: Month 0, month 2, month 12.
Inflammatory tone (as assessed by serum C-reactive protein)
Time frame: Month 0, month 2, month 12.
Quality of life questionnaire (as assessed by PDQ-39 [0-100])
Time frame: Month 0, month 2, month 6, month 12.
Perceived stress (as assessed by PSS [0-40])
Time frame: Month 0, month 2, month 6, month 12.
Rumination (as assessed by RRS [26-104])
Time frame: Month 0, month 2, month 6, month 12.
Mindfulness skills (as assessed by FFMQ [39-195])
Time frame: Month 0, month 2, month 6, month 12.
Self-compassion as assessed by SCS [12-84])
Time frame: Month 0, month 2, month 6, month 12.
Self-efficacy (as assessed by GSES [10-40])
Time frame: Month 0, month 2, month 6, month 12.
Positive appraisal (as assessed by PASS)
Time frame: Month 0, month 2, month 6, month 12.
Decision making task
Time frame: Month 0, month 2, month 12.
Salivary cortisol
Time frame: Month 0, month 12.
Resting state network reactivity to a stressor (fMRI)
Time frame: Month 0, month 12.
Grey matter volume of stress-related regions (MRI)
Time frame: Month 0, month 12.
Structural integrity of substantia nigra and locus coeruleus (LC)
Time frame: Month 0, month 12.
Functional integrity of nigro-striatal dopamine system
Time frame: Month 0, month 12.
Hair cortisol (HC)
Time frame: Month 0
Decision making task (HC)
Time frame: Month 0
Salivary cortisol (HC)
Time frame: Month 0
Resting state network reactivity to a stressor (fMRI) (HC)
Time frame: Month 0
Structural integrity of substantia nigra and locus coeruleus (HC)
Time frame: Month 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 33275908Cieza 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.
- Background: PubMed 3352672Kish 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.
- Background: PubMed 22001159Hemmerle 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.
- Background: PubMed 33462213van 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.
- Background: PubMed 24565378de 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.
- Background: PubMed 31585362Burtscher 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.
- Background: PubMed 33094858van 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.
- BackgroundBaer, 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).
- Derived from this study: PubMed 38918695van 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.
- 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.
Rick Helmich, MD PhD principal investigator
Radboud University Medical Centre; Donders Institute for Brain, Cognition and Behaviour
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT in people with Parkinson's Disease, run by Radboud University Medical Center at 1 site in Netherlands.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Psychological distress post-intervention (as assessed by HADS [0-42]) (time frame: Month 2). 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 NCT05779137, which also lists 9 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 27 Mar 2026.