Ires Ghielen

132 Chapter 7 Group (2 levels: control and experimental) and Time (3 levels: baseline, assessment at week 6 (directly post-treatment) and assessment week 18 (3 month follow up)). Ethical considerations Prior to study participation, all patients will be asked to sign a written informed consent. The study was approved by the ethics committee of the VU University medical centre (study number: 13.421). Data monitoring The data and safety monitoring board will guard the quality and safety during this study, according to the Good Clinical Practice guidelines. Discussion (expected results) Wearing-off is an inevitable and disabling consequence of long-term DRT in patients with PD and WRA is a concept characterized by a complex reciprocal interaction of motor and non-motor symptoms. The general neglect of these complex interactions in the TAU leaves a gap for treatment innovation. BEWARE is a promising therapy for WRA in PD since it specifically focuses on the interaction between physical and mental symptoms. The specific and unique combination of elements of the therapy aim to increase self-efficacy, by strengthening ones own belief to adequately cope with the wearing off and the disproportional concurrent feelings of anxiety, rather than symptom reduction or elimination. Since the development of wearing-off is associated with long-term treatment of PD with DRT, as well as to an early onset of disease, longer disease duration, and higher doses of levodopa [5,17,46], we will inadvertently include patients that are in a more advanced stage of the disease. Therefore, we must pay specific attention to the potential additional difficulties with patient compliance regarding the amount of effort and commitment we demand from the patients during the twice-weekly intervention. Based on previous research in combination with our own experience based on a small open pilot study in four PD patients (results not published), we expect to see a significantly bigger improvement in self-efficacy in the BEWARE condition as compared with the TAU condition. A decrease in BAI total score was observed in the patients that participated in the pilot study. The patients in the pilot study reported very positive subjective effects of the intervention. In particular the group aspect