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

Recruiting

Conditions: Parkinson's Disease
10028037

Registration Number: NL-OMON51467

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

- A diagnosis of idiopathic Parkinson's Disease made by a movement disorders
specialist.
- Parkinson disease duration is <=7 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 (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 mild cognitive impairment or
dementia).
- Previous participation in MBSR or MBCT (>4 sessions).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is severity of psychological distress, measured with the<br /><br>validated Hospital Anxiety and Depression Scale (HADS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will measure inflammatory markers in blood, cortisol levels from hair and<br /><br>saliva, and collect several clinical and MRI measures at baseline (T0),<br /><br>post-intervention (T1) and after a follow-up period of 12 months after baseline<br /><br>(T2).</p><br>