Ires Ghielen

155 BEWARE: Results of the pilot RCT The number of wearing-off symptoms at baseline did not seem to influence the treatment effect. However, the number of wearing-off symptoms might not be a good criterion to assess the severity of the wearing-off, since patients may experience just one but very disabling wearing-off symptom versus several, less disabling wearing-off symptoms. The severity of discomfort, instead of the number of symptoms, is not included in the WOQ-19. In the future it might be better to use other measures to assess disease severity, such as the Movement Disorder Society- Unified Parkinson’s Disease Scale (MDS-UPDRS) part III and IV [46], in combination with times of medication intake. Results from the qualitative analysis indicate that the burden of the frequency of therapy sessions was high for several patients while the duration of each session could be increased. In addition the involvement of caregivers was missed. In a follow-up study, the frequency of therapy sessions should be reduced (to once a week), while the length of the sessions can be extended to one and half hour. In addition, more homework with proper monitoring can be implemented to promote implementation of the treatment principles in daily life, and the addition of 1 or 2 home sessions also involving the partner and/or the caregiver might add to the long-term effects of the intervention. In addition, a booster session at 12 weeks after treatment completion might also facilitate better implementation into daily life and long-term effects, as is also argued by Morris and colleagues [47]. Self-help material should be developed so that patients have something they can fall back on at home in between sessions and after completion of the training. Concerning the content of the BEWARE training, more time will be spent on exercises concerning valued living and less time will to be spent on repetition of previously trained elements. Homework will focus more on the involvement of the patients’ daily life (motor and non-motor) struggles, and the amount of homework will be increased with the goal to perform one exercise with a duration of 10-15 minutes every day. In addition, cognitive demands will be decreased by focusing more on the body and daily life activities, and by more repetition using the self-help material and a booster session. A major strength of this study is the implementation of a TAU group, which controlled for the physical therapy elements that were also implemented in the BEWARE group. The additional effect of the psychological elements was therefore investigated. This was the first time this new approach to the treatment of PD patients with wearing- off, which includes both psychological and physical elements, was investigated. The number of participants, although calculated prior to study set-up, could have been insufficient to achieve sufficient statistical power, which can be considered a limitation. 8