Ires Ghielen

125 BEWARE: Study protocol of the pilot RCT Introduction Parkinson’s disease (PD) is a progressive neurodegenerative disorder of the central nervous system with a prevalence of 1.6% among people of 65 years or older [1]. The neurobiological hallmark of PD is a loss of dopaminergic cells, causing the typical motor symptoms such as tremor, rigidity, slowness of movement, postural instability and freezing. Non-motor symptoms, such as autonomic failure, fatigue, depression and anxiety are also prevalent, likely due to an additional involvement of non-dopaminergic systems [2]. To supplement the shortage of dopamine, levodopa treatment is currently the most applied and effective symptomatic treatment [3]. When the dopamine replacement therapy (DRT) takes effect and symptoms become less prominent, the patient is in the ‘on’ state. In contrast, the state in which the patient is in need of a new dose of dopamine and experiences intensified PD symptoms, is referred to as the ‘off’-state. A re-emergence of PD symptoms, shifting from an ‘on’ state to an ‘off’ state, is called wearing-off. This typically occurs prior to the next scheduled dose of dopaminergic therapy taking effect [4], and is related to a longer disease duration [5]. Motor and non-motor symptoms have reciprocal influences [6]. About seventy- five percent of patients with motor fluctuations, including wearing-off, experience mood and/or anxiety fluctuations in parallel [7]. This wearing-off related anxiety (WRA) is characterized not only by subjective feelings of anxiety but also by physical complaints, such as sweating, abdominal distress and shortness of breath. Rutten et al [8] showed, by performing a factor analysis on the Beck Anxiety Inventory (BAI), that anxiety symptoms in PD show significant overlap with both autonomic and motor symptoms. This finding demonstrates that physical and mental symptoms are intertwined in PD. The physical symptoms accompanying WRA are often incongruent with the actual severity and physical impact of motor symptoms of wearing-off, suggesting an increased sensitivity and reactivity to the occurrence of wearing-off symptoms and heightened body awareness in these patients. Body awareness involves an attentional focus on and awareness of internal bodily sensations [9]. An abnormal increase in body awareness can be maladaptive [9] and is, in general, also related to anxiety disorders [10-14]. The anxiety symptoms experienced by PD patients are often responsive to dopaminergic medication [15]. Therefore, the first therapeutic approach for treating 7