Ires Ghielen

127 BEWARE: Study protocol of the pilot RCT improving psychological functions and reducing pain and stress [29]. Since PD is a chronic disease and is accompanied by both physical and mental symptoms (motor and non-motor symptoms), combing mindfulness-based therapy with physical rehabilitation might be of potential benefit for PD patients with WRA. BEWARE is an integrated body awareness intervention, combining acceptance and commitment therapy (ACT), in which mindfulness training is incorporated, with physical therapy. We will test the effectiveness of this intervention (compared with treatment as usual (TAU)) in terms of self-efficacy in PD patients with WRA. We hypothesize that the BEWARE intervention will be more effective in improving self- efficacy than physical therapy alone (TAU). Methods/Design Study design This will be a single-blind randomized controlled trial. Thirty-six PD patients that experience WRA will be randomly allocated to either the BEWARE training group (n=18, 3 groups of 6 patients) or to a control group receiving physical group therapy, which is a usual form of treatment for wearing-off in PD patients at the VU University medical center (n=18, 3 groups of 6 patients). Block-randomization is done using concealed opaque envelopes. All participants are asked to maintain the regular medication schedule during the six-week intervention. Assessments are conducted prior to the intervention, at six weeks directly after the intervention and at 18 weeks follow-up. The assessments will be performed by a blinded investigator who is not involved in the intervention and/or randomization. Figure 1 demonstrates the study design according to the CONSORT statement [30]. Patient recruitment The patients will be recruited from the outpatient clinic of the VU University medical centre. The neurologists and psychiatrist will be asked to approach PD patients who, in their view, experience WRA. In addition, an announcement will be placed on the website of the Dutch Parkinson patient association (Parkinson Vereniging) and in their magazine. In- and exclusion criteria are listed below. Patient inclusion criteria 1. Diagnosed with idiopathic PD according to the UK PD Brain Bank criteria [31]. 2. Experiencing wearing-off symptoms and/or response fluctuations, as measured with the Wearing-Off Questionnaire 19 [32]. A patient is considered 7