A E P Mulders1, A J H Moonen1, K Dujardin2, M L Kuijf3, A Duits1, B Flinois4, R L H Handels1, R Lopes5, A F G Leentjens6. 1. Department of Psychiatry and Neuropsychology, Maastricht University Medical Centre, Maastricht, The Netherlands. 2. Degenerative & Vascular Cognitive Disorders, University of Lille, Lille, France; Neurology and Movement Disorders Department, CHU, Lille, France. 3. Department of Neurology, Maastricht University Medical Centre, Maastricht, The Netherlands. 4. Neurology and Movement Disorders Department, CHU, Lille, France. 5. Degenerative & Vascular Cognitive Disorders, University of Lille, Lille, France; Neuroimaging Department, CHU Lille, Lille, France. 6. Department of Psychiatry and Neuropsychology, Maastricht University Medical Centre, Maastricht, The Netherlands. Electronic address: a.leentjens@maastrichtuniversity.nl.
Abstract
BACKGROUND:Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a negative effect on motor symptoms and quality of life. To date, no clinical trials specifically targeting anxiety in PD patients have been published. OBJECTIVE: To describe the rationale and methodology of a randomised controlled trial (RCT) that aims to study the clinical effectiveness, alterations in brain circuitry, and cost-effectiveness of cognitive behavioural therapy (CBT) for anxiety in PD. METHODS: This study is a prospective, two-centre RCT in which sixty PD patients with anxiety will be randomised to CBT treatment and clinical monitoring (intervention group) or to clinical monitoring only (control group). The CBT module used in this study was specifically developed to address symptoms of anxiety in PD patients. Participants will undergo standardised clinical, cognitive and behavioural assessment at baseline and at 2 follow-up measurements, as well as resting-state fMRI and DTI scanning before and after the intervention. The primary outcome measure is changes in severity of anxiety symptoms. Secondary outcome measures involve long-term changes in anxiety symptoms, changes in functional and structural connectivity between limbic and frontal cortices, and cost-effectiveness of the treatment. The study is registered at the ClinicalTrials.gov database under registration number NCT02648737. CONCLUSION: This study is the first that evaluates both the clinical effectiveness, cost-effectiveness, as well as the biological impact of CBT for anxiety in PD patients that, if proven effective, will hopefully contribute to a better and evidence-based approach for these non-motor symptoms.
RCT Entities:
BACKGROUND:Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a negative effect on motor symptoms and quality of life. To date, no clinical trials specifically targeting anxiety in PDpatients have been published. OBJECTIVE: To describe the rationale and methodology of a randomised controlled trial (RCT) that aims to study the clinical effectiveness, alterations in brain circuitry, and cost-effectiveness of cognitive behavioural therapy (CBT) for anxiety in PD. METHODS: This study is a prospective, two-centre RCT in which sixty PDpatients with anxiety will be randomised to CBT treatment and clinical monitoring (intervention group) or to clinical monitoring only (control group). The CBT module used in this study was specifically developed to address symptoms of anxiety in PDpatients. Participants will undergo standardised clinical, cognitive and behavioural assessment at baseline and at 2 follow-up measurements, as well as resting-state fMRI and DTI scanning before and after the intervention. The primary outcome measure is changes in severity of anxiety symptoms. Secondary outcome measures involve long-term changes in anxiety symptoms, changes in functional and structural connectivity between limbic and frontal cortices, and cost-effectiveness of the treatment. The study is registered at the ClinicalTrials.gov database under registration number NCT02648737. CONCLUSION: This study is the first that evaluates both the clinical effectiveness, cost-effectiveness, as well as the biological impact of CBT for anxiety in PDpatients that, if proven effective, will hopefully contribute to a better and evidence-based approach for these non-motor symptoms.
Authors: Gregory M Pontone; Nadeeka Dissanayka; Liana Apostolova; Richard G Brown; Roseanne Dobkin; Kathy Dujardin; Joseph H Friedman; Albert F G Leentjens; Eric J Lenze; Laura Marsh; Lynda Mari; Oury Monchi; Irene H Richard; Anette Schrag; Antonio P Strafella; Beth Vernaleo; Daniel Weintraub; Zoltan Mari Journal: NPJ Parkinsons Dis Date: 2019-12-11
Authors: Anja J H Moonen; Anne E P Mulders; Luc Defebvre; Annelien Duits; Bérengère Flinois; Sebastian Köhler; Mark L Kuijf; Anne-Claire Leterme; Dominique Servant; Marjolein de Vugt; Kathy Dujardin; Albert F G Leentjens Journal: Mov Disord Date: 2021-02-22 Impact factor: 9.698