Test whether a mindfulness-based cognitive therapy intervention (MBCT) improves psychological distress, clinical symptoms, slows neurodegeneration, and/or enhances neuroplasticity in PD.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Parkinson*s disease (PD) patients are very sensitive to the effects of
psychological stress. The prevalence of stress-related neuropsychiatric
symptoms is high, stress worsens motor symptoms and chronic stress might also
accelerate disease progression, as suggested by animal models.
Mindfulness-based interventions (MBI) train participants to focus on the
present moment without judgement, while allowing experienced difficulties.
Previous studies suggest that MBIs can reduce stress and improve depression and
anxiety in PD, but many studies have been small-scale or have mixed results.
The effects on motor symptoms and underlying cerebral mechanisms remain fully
unclear.
Study objective
Test whether a mindfulness-based cognitive therapy intervention (MBCT) improves
psychological distress, clinical symptoms, slows neurodegeneration, and/or
enhances neuroplasticity in PD.
Study design
Randomized controlled trial.
Intervention
62 PD patients will receive an 8-week mindfulness-based cognitive therapy
(MBCT) program, and 62 PD patients receive treatment as usual (TAU).
Study burden and risks
The load on patients consists mostly of the time spent on the intervention,
which will be eight 2-2.5-hour sessions and a 4-hour silence day in the
mindfulness group with daily exercises to be performed at home. In addition,
there will be three study visits (baseline (T0), post-intervention (T1) and 12
months after baseline (T2)) where clinical, psychological, blood samples and
MRI measures will be collected. During these study visits all measurements
happen OFF-medication and therefore symptoms might temporarily worsen, which
can lead to discomfort. Except for three blood samples that will be taken, all
measures (MRI, clinical assessments, questionnaires, cortisol) are
non-invasive. Finally, participants are asked to fill out home questionnaires
at T0, T1, T2, and in the middle of the follow-up period (6 months after
baseline). Mindfulness adherence will be assessed every 2 months (exclusively
in the mindfulness group). Participants could directly benefit from the
intervention. Participants in the control group are offered the possibility to
follow the MBCT course after the study is finished.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
For patients:
- A diagnosis of idiopathic Parkinson's Disease made by a movement disorders
specialist.
- Parkinson 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.
For healthy controls:
- Subject can read and understand the Dutch language.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05779137 |
| CCMO | NL81309.091.22 |