The Effect of Mindfulness-based Cognitive Therapy on Psychological Distress in People With Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Netherlands
Donders Centre for Cognitive Neuroimaging
RECRUITING
Nijmegen
Contact Information
Primary
Franziska Goltz, MSc
franziska.goltz@donders.ru.nl
+31625512157
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2027-01
Participants
Target number of participants: 174
Treatments
Experimental: Mindfulness based cognitive therapy (MBCT)
62 patients will receive a mindfulness based intervention.
No_intervention: Treatment as usual (TAU)
62 patients will receive treatment as usual, this will form a (passive) control group to the MBCT group.
No_intervention: Healthy control (HC)
50 healthy individuals without PD will not be randomized. This arm will only be measured once at baseline.
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov