Parkinson's Disease Clinical Trial
Official title:
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
NCT number | NCT02648737 |
Other study ID # | 11169 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | December 2019 |
Verified date | February 2020 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life. With this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this module in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral connectivity. Effective CBT treatment of anxiety will provide patients with behavioural and anxiety management techniques that can give lasting benefits, not only on anxiety symptoms, but potentially also on motor symptoms.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Idiopathic PD according to the Queens Square Brain Bank diagnostic criteria - Presence of clinically relevant anxiety symptoms, as operationalized by the Mini International Neuropsychiatric Inventory (MINI), sections for social phobia (F) and GAD (H), and/or a Parkinson Anxiety Scale (PAS) persistent score >9 and/or PAS avoidance score >3. - 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., selective serotonin re-uptake inhibitors) 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. - Signed informed consent Note: In order to achieve a representative study sample, patients will be included irrespective of their disease stage or their current antiparkinsonian medication. Exclusion Criteria: - Parkinsonian syndromes or neurodegenerative disorders other than PD - Dementia or severe cognitive decline, operationalized as a Montreal Cognitive Assessment (MOCA) score < 24 - Contra-indications for magnetic resonance imaging - Major depressive disorder (MDD) as defined by the criteria of a DSM-V diagnosis for MDD - Abuse of alcohol, drugs or benzodiazepines. |
Country | Name | City | State |
---|---|---|---|
France | Neurology and Movement Disorders Unit, Lille University Hospital | Lille Cedex | |
Netherlands | Maastricht University Medical Centre | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Michael J. Fox Foundation for Parkinson's Research |
France, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in anxiety score as measured with the Hamilton Anxiety Rating Scale (HARS). | Baseline assessment (T0) and post-treatment assessment (T1; after 10 weeks) | ||
Secondary | Changes in cerebral connectivity between limbic and frontal cortices as measured with resting state blood-oxygen-level dependent functional magnetic resonance imaging (BOLD fMRI) and diffusion tensor imaging (DTI) | MRI scanning at baseline (T0) and post-treatment (T1; after 10 weeks) | ||
Secondary | Long term clinical effectiveness of the CBT module measured by the change in HARS score | 3 months follow-up (T2) and 6 months follow-up (T3) |
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