Cognitive Behavioural Therapy for anxiety disorders in patients with Parkinson*s disease: a Randomized, Controlled Trial of the clinical effectiveness and changes in cerebral connectivity
- Conditions
- anxiety disorders1002803710002861
- Registration Number
- NL-OMON46897
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
* Idiopathic PD according to the Queens Square Brain Bank diagnostic criteria
* Presence of clinically relevant anxiety symptoms
* Using a stable dose of levodopa or other antiparkinsonian medication for at least one month
* No other current psychological treatment for anxiety; pharmacotherapy (e.g., SSRIs) is allowed if a stable dose is used at least 2 months prior to participation and the patient still meets inclusion criteria. During the trial the dosage should not be changed. Medication use and mental health care will be tracked throughout the study.
* Age between 35 and 80 years
* Signed informed consent
* Parkinsonian syndromes or neurodegenerative disorders other than PD
* Dementia or severe cognitive decline
* Major depressive disorder (MDD) as defined by the criteria of a DSM-V diagnosis for MDD
* Abuse of alcohol, drugs or benzodiazepines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the difference in change in anxiety score<br /><br>between baseline and post-treatment as measured with the Hamilton Anxiety<br /><br>Rating Scale (HARS) between the intervention- and control group. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Differences in changes between the intervention- and control group in<br /><br>cerebral connectivity between limbic and frontal cortices before and after<br /><br>treatment, as measured with resting state BOLD fMRI and DTI.<br /><br>- Long term clinical effectiveness of the CBT module, measured by the change in<br /><br>HARS score after 3 months (between group) and 6 months (within group) follow-up<br /><br>in the intervention- and control group.<br /><br>- The difference between the intervention- and control group in generic<br /><br>health-related quality of life (EQ-5D-5L and PDQ8) and well-being (ICECAP-O)<br /><br>before and after treatment.<br /><br>- The cost-effectiveness of CBT as treatment for anxiety in PD patients as<br /><br>measured by the Resource Use Questionnaire. </p><br>