The effect of mindfulness-based cognitive therapy on psychological distress in people with Parkinson*s Disease: clinical effects and cerebral mechanisms.

The effect of mindfulness-based cognitive therapy on psychological distress in people with Parkinson's Disease: clinical effects and cerebral mechanisms. - MIND-PD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51467

Enrollment

174

Registered

2022-09-20

Start date

2023-04-17

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

62 PD patients will receive an 8-week mindfulness-based cognitive therapy (MBCT) program, and 62 PD patients receive treatment as usual (TAU).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For patients: - A diagnosis of idiopathic Parkinson's Disease made by a movement disorders specialist. - Parkinson disease duration is 10 points). - Subject can read and understand the Dutch language. For healthy controls: - Subject can read and understand the Dutch language.

Exclusion criteria

Exclusion criteria: For patients: - Severe neurological or psychiatric co-morbidity (psychosis or suicidality). - Contraindications for MRI (i.e.: 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). For healthy controls: - Severe neurological or psychiatric co-morbidity (psychosis or suicidality). - Contraindications for MRI (i.e.: brain surgery in medical history, claustrophobia, an active implant, epilepsy, pregnancy, and/or metal objects in the upper body that are incompatible with MRI).

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is psychological stress complaints, measured with the validated Hospital Anxiety and Depression Scale (HADS) post-intervention (T1; for the MBCT group immediately post-intervention, for the control group 2-3 months after T0).	—

Secondary

Measure	Time frame
We will measure inflammatory markers in blood, cortisol levels from hair and saliva, and collect several clinical and MRI measures at baseline (T0), post-intervention (T1) and after a follow-up period of 12 months after baseline (T2). Baseline outcomes will be compared with health- and gendermatched healthy controls.	—

Countries

Netherlands

Contacts

Public ContactRCG Helmich

Radboud Universitair Medisch Centrum

rick.helmich@radboudumc.nl0243614308

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026