Ires Ghielen

147 BEWARE: Results of the pilot RCT a Hoehn & Yahr (H&Y) staging of 2 or 3 in the ON stage, as retrospectively assessed by the physical therapists. We assessed this retrospectively over 12 treatment sessions to obtain a reliable indicator of the disease stage, since H&Y scores are dependent on the (moment of the) day. Twelve patients, six in each condition, used pharmacotherapy for anxiety and/or depressive symptoms during the study (see table 1). There was a non-selective drop-out of 26%, which was mainly due to the burden related to the frequency of therapy sessions (including travel distance). Outcomes In table 2 the means and standard deviations of the outcome measures are shown, per group treatment. Primary outcome : There was no significant differential treatment effect over time on the primary outcome measure ‘self-efficacy’ (see table 3). Secondary outcomes : There was a significant improvement in emotional wellbeing, as measured with the PDQ-39, in the BEWARE condition compared with the TAU condition, both at post-treatment and at follow-up. In addition, the timed balance test significantly improved with the BEWARE training compared with the TAU, also both at post-treatment and at follow-up. The regression coefficient of the stigmatization subscale of the PDQ-39 showed a trend-significant improvement in the BEWARE condition compared to the TAU condition. Figure 2 illustrates the changes over time, separately for the two conditions. Covariates Severity of wearing-off, represented by the number of wearing-off symptoms that patients reported at baseline, the level of anxiety, represented by the BAI total score, and the LEDD score, did not influence the effect of the intervention. However, cognitive status, represented by the MMSE total score, modulated the treatment effect for depressive symptoms (BDI): patients that had a higher score on the BDI, but were cognitively most intact, showed larger improvements after the BEWARE treatment. Besides this finding, the MMSE score had a significant influence on the intervention effect for freezing-of-gait (p=0.009), quality of life (PDQ) - emotional wellbeing (p=0.045), PDQ - social support (p=0.049), activities of daily living (NEAI) – household (p=0.047), and NEAI - leisure time (p=0.026). 8

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