A Decentralized Trial of Individual Video-assisted Cognitive Behavioural Therapy for Depressive Disorder in Parkinson's Disease.

More than 1 million people in Europe suffer from Parkinson's disease (PD), a brain disorder manifesting with a motor syndrome and several non-motor features. Neuropsychiatric symptoms, like anxiety and depression, are common in patients with PD, and has profound effects on quality of life and activities of daily living of the patient, and caregiver burden. Cognitive behavioral therapy (CBT) has proven efficient for depressive symptoms, but treatment availability to the general patient with PD is low. Thus, there is an urgent need for individualized remote approaches that can be of benefit to patients on a national scale. This study is a remote, randomized delayed start trial of the effectiveness of videoconference based cognitive behavioral therapy (eCBT) for PD patients with depressive symptoms. N=120 participants with PD and depressive symptoms will be recruited from neurological clinics across four health regions in Norway and self-reference, and randomized into two arms: (A) immediate eCBT with concurrent with TAU and (B) a delayed start (14 weeks) of eCBT with TAU alone. Patients will be assessed at baseline before allocation to treatment, with followed up evaluations 14, 28 and 42 weeks after baseline. The trial is designed as a state-of-the-art remote clinical trial, that can be easily implemented existing health services, resulting in a rapid implementation and improvement of treatment for patients with PD, and potentially large translational value to other brain disorders.