Mindfulness-based Cognitive Therapy for Parkinson's Disease
The Effect of Mindfulness-based Cognitive Therapy on Psychological Distress in People With Parkinson's Disease
This study tests if Mindfulness-Based Cognitive Therapy can help people with Parkinson's Disease feel less stressed and improve their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT05779137 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Mindfulness-Based Cognitive Therapy (MBCT) on individuals with Parkinson's Disease (PD), focusing on how stress reduction can improve both motor and non-motor symptoms. Participants diagnosed with idiopathic PD and experiencing mild to moderate psychological distress will undergo MBCT to assess its impact on their condition. The study aims to provide evidence on the relationship between stress and PD progression, potentially leading to new treatment approaches. The intervention will be conducted at the Donders Centre for Cognitive Neuroimaging in Nijmegen.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with idiopathic Parkinson's Disease for 10 years or less, experiencing mild to moderate psychological distress.
Not a fit: Patients with severe neurological or psychiatric conditions, significant cognitive dysfunction, or those who have previously participated in similar mindfulness programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with Parkinson's Disease by alleviating stress-related symptoms.
How similar studies have performed: Previous studies have shown promising results for mindfulness interventions in various psychological and somatic disorders, suggesting potential for success in this novel application for Parkinson's Disease.
Eligibility criteria
Show full inclusion / exclusion 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. 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).
Where this trial is running
Nijmegen
- Donders Centre for Cognitive Neuroimaging — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Rick Helmich, MD PhD — Radboud University Medical Centre; Donders Institute for Brain, Cognition and Behaviour
- Study coordinator: Anouk van der Heide, MSc
- Email: anouk.vanderheide@donders.ru.nl
- Phone: +31628856881
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.