BEWARE: Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson’s disease: study protocol for a randomized controlled trial

Abstract

BackgroundThe 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/DesignThis 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.DiscussionBecause 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 registrationClinicalTrials.gov identifier: NCT02054845. Date of registration: 30 January 2014.

Remote delivery of psychological interventions for Parkinson's disease

“…A recent six-week group mindfulness intervention involving lifestyle management strategies for PD patients showed a significant reduction in depression and stress, and improvements in mindfulness and ADL at sixmonth follow-up (Advocat et al, 2016). In-person ACT-based interventions for wearing-off related anxiety (Dissanayaka et al, 2016b) associated with prolonged dopamine-replacement therapy in PD are currently underway (Ghielen et al, 2015). These promising findings support the future adaptation of such psychological interventions for flexible, home-based delivery, thereby increasing telehealth-based treatment options for PD patients beyond CBT, and enhancing patient-centerd care.…”

The effect of kinesiophobia on physical activity, balance, and fear of falling in patients with Parkinson’s disease

“…As a result, multidisciplinary rehabilitation programs that support functionality and include cognitivebehavioral strategies and approaches for secondary effects due to fear of falling, balance, physical activity level, and kinesiophobia may be beneficial for Parkinson's patients to reduce the negative effects of kinesiophobia and the perceived level of disability. Acceptance and commitment therapy-based exercise programs such as BEWARE, which are currently being studied, may also be beneficial in reducing kinesiophobia in patients with PD (Ghielen et al, 2015).…”

Exploring Nonmotor Neuropsychiatric Manifestations of Parkinson Disease in a Comprehensive Care Setting

“…Other trials for therapy involving body awareness training for the treatment of wearing off-related anxiety and a mindfulness-based exercise have shown that these modalities are helpful in balance and well-being. 32,33 Serial electroconvulsive therapy (ECT) has not been well studied but was found to be effective in a case study of severe anxiety in patients with PD. 34…”