Ires Ghielen

153 BEWARE: Results of the pilot RCT Discussion This pilot randomized controlled phase II study investigated a newly developed intervention involving body awareness training (BEWARE) for WRA in patients with PD. Patients that participated in the BEWARE treatment (compared with TAU) showed improved emotional wellbeing as well as standing balance, both at post-treatment and follow-up. Feelings of social stigmatization trend-significantly decreased in the BEWARE condition compared with the TAU condition. The BEWARE treatment was not superior to TAU with regard to the primary outcome measure self-efficacy (GSES). One explanation involves the content of the BEWARE intervention, that will be further optimized. The efficacy of the treatment might increase by removing or adjusting exercises that appeared less applicable to WRA according to the therapists. Since roughly half of the time of each BEWARE treatment session focused on ACT principles, instead of physical exercises as in the TAU condition, the treatment contrast regarding time that is spent on coping with WRA between the two conditions might not have been large enough to achieve significant between group differences in self-efficacy. In addition, based on the experience and feedback of participants, the frequency of the intervention sessions could be reduced while the duration of each session should be increased to improve feasibility and compliance. Also, more home-assignments or tools should be developed to achieve a better implementation of the principles in daily life. Another explanation might be that the GSES is not responsive enough to measure changes in coping-related aspects of WRA in patients with PD. Certain self-efficacy beliefs that relate to controlling the disease and its symptoms may be unhelpful in the context of WRA, as Dennison and colleagues [41] also argue in a review of psychological correlates of adjustment in patients with multiple sclerosis. Critical review of the GSES reveals that while several items focus on dealing with unexpected situations, other statements in the questionnaire involve problem solving . In an ACT- based intervention like BEWARE, the effect might be measured better by specifically focusing on the subject’s perceived capability to deal with WRA, instead of solving or controlling the situation. Since patients are taught to focus on what they find important, despite of their illness, another questionnaire might be more applicable and sensitive to change. While no such specific questionnaire is currently available nor validated for PD, one may consider the Engaged Living Scale [42] or the Goal Attainment Scaling [43]. These questionnaires focus on personal goals and values, which may be more closely related to the main focus of the BEWARE treatment, but would need to be validated in PD prior to implementation in a follow up study. 8

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