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

NCT ID: NCT05779137

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2027-01-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness based cognitive therapy (MBCT)

62 patients will receive a mindfulness based intervention.

Group Type: EXPERIMENTAL

MBCT

Intervention Type: 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.

Treatment as usual (TAU)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy control (HC)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MBCT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rick Helmich, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Donders Centre for Cognitive Neuroimaging

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Franziska Goltz, MSc

Role: CONTACT

franziska.goltz@donders.ru.nl

+31625512157

Facility Contacts

Franziska Goltz, MSc

Role: primary

franziska.goltz@donders.ru.nl

References

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 38918695 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NL81309.091.22

Identifier Type: -

Identifier Source: org_study_id