BACKGROUND: The wearing-off phenomenon in patients with Parkinson's disease (PD) 
is a complication of prolonged levodopa usage. During this phenomenon, motor 
symptoms such as rigidity and freezing re-emerge. This is often accompanied by 
non-motor symptoms, including anxiety, the so-called wearing-off related anxiety 
(WRA). Current treatment options are limited and typically focus on either the 
physical or mental aspects of wearing-off. An integrated approach seems 
warranted in order to optimally address the complex reciprocal interactions 
between these aspects. Also, because wearing-off is eventually inescapable, 
treatment needs to focus on coping, acceptance, and self-efficacy. We therefore 
developed an integrated body awareness intervention, combining principles from 
physical therapy with acceptance and commitment therapy to teach patients to 
deal with WRA. This study will investigate whether this new intervention, named 
BEWARE, is more effective than treatment as usual in increasing self-efficacy.
METHODS/DESIGN: This is a single-blinded randomized controlled trial in 36 PD 
patients who experience WRA. Subjects will be recruited from the outpatient 
clinic for movement disorders of the VU University Medical Center. After 
providing written informed consent, patients will be randomly assigned to an 
experimental (BEWARE) or treatment-as-usual (physical therapy) group. Clinical 
assessments will be performed prior to the intervention, directly after the 
6-week intervention period, and at 3-month naturalistic follow-up by a blinded 
investigator not involved in the study. The primary outcome measure is 
self-efficacy, and secondary outcomes focus on mobility, daily functioning, 
anxiety, and quality of life.
DISCUSSION: Because wearing-off is an inevitable consequence of levodopa therapy 
and current treatment options are insufficient, a multidisciplinary intervention 
that addresses both physical and mental aspects of wearing-off in PD may foster 
additional benefits for treating WRA in PD patients over mono-disciplinary care 
alone.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02054845. Date of 
registration: 30 January 2014.