NCT05779137Fut, nem toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 27.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 174 (tervezett)
- Első benyújtás
- 2023. jan. 12.
- Kezdés
- 2023. ápr. 17.
- Elsődleges befejezés
- 2026. márc. 13.
- Fő szponzor
- Radboud University Medical Center
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT05779137
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 174
- 2023. ápr. 17. és az elsődleges befejezés (2026. márc. 13.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Previous participation in MBSR or MBCT (>4 sessions).
- Detailed knowledge about the nature of the stress induction paradigm prior to participating in the study.
Más betegség
- 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).
Egyéb
- Moderate to severe head tremor (to avoid artifacts caused by extensive head motion during scanning).
Kiket keres a vizsgálat
- 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.
Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Donders Centre for Cognitive Neuroimaging | Nijmegen | Hollandia | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.