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

NCT05779137 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Rick Helmich, MD PhD · Radboud University Medical Centre; Donders Institute for Brain, Cognition and Behaviour

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2026-03-13
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779137 on ClinicalTrials.gov