Mindfulness therapy tested to calm Parkinson's stress
NCT ID NCT05779137
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether mindfulness-based cognitive therapy (MBCT) can reduce psychological distress in people with Parkinson's disease. 174 participants with mild-to-moderate stress symptoms will either receive MBCT or continue usual care. The main goal is to see if MBCT lowers anxiety and depression scores after the program.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mindfulness-based cognitive therapy
- What this could lead to
- If it works, this could offer a drug-free way to ease anxiety and depression in Parkinson's, and possibly slow disease progression.
- What could go wrong
- This is a mid-sized trial testing a behavioral intervention, not a drug. Results may be modest or not generalizable, and benefits may not last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 174 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria for the RCT: * 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. Exclusion criteria for the RCT: * 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). Inclusion criteria (HC group): • Participants of the HC group must be able to read and understand the Dutch language. Exclusion criteria (HC group): * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Donders Centre for Cognitive Neuroimaging
Nijmegen, 6525 EN, Netherlands
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