NCT05779137Active, not recruiting
The Effects of Mindfulness-based Cognitive Therapy in People With Parkinson's Disease
The Effect of Mindfulness-based Cognitive Therapy on Psychological Distress in People With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- First submitted
- 12 Jan 2023
- Start date
- 17 Apr 2023
- Primary completion date
- 13 Mar 2026
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT05779137
What you commit to
- Study type: Interventional
- Planned participants: 174
- From 17 Apr 2023 to the primary completion date, 13 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in MBSR or MBCT (\>4 sessions).
- Detailed knowledge about the nature of the stress induction paradigm prior to participating in the study.
Other illness
- 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).
- 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).
Other
- Moderate to severe head tremor (to avoid artifacts caused by extensive head motion during scanning).
Who the study is looking for
- 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.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Donders Centre for Cognitive Neuroimaging Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.