title: 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: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT02054845. Date of registration: 30 January 2014.
authors.affiliation: Department of Psychiatry, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands. i.ghielen@vumc.nl.
authors.forename: Ires
authors.initials: I
authors.lastname: Ghielen
authors.affiliation: Department of Psychiatry, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands. oa.vandenheuvel@vumc.nl.|Department of Anatomy & Neurosciences, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. oa.vandenheuvel@vumc.nl.|Neuroscience Campus Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. oa.vandenheuvel@vumc.nl.
authors.forename: Odile A
authors.initials: OA
authors.lastname: van den Heuvel
authors.affiliation: Department of Rehabilitation Medicine, MOVE Research Institute Amsterdam, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands. cjt.degoede@vumc.nl.
authors.forename: Cees J T
authors.initials: CJ
authors.lastname: de Goede
authors.affiliation: Department of Medical Psychology, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands. m.degier1@vumc.nl.
authors.forename: Marieke
authors.initials: M
authors.lastname: Houniet-de Gier
authors.affiliation: Department of Medical Psychology, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands. eh.collette@vumc.nl.
authors.forename: Emma H
authors.initials: EH
authors.lastname: Collette
authors.affiliation: Department of Rehabilitation Medicine, MOVE Research Institute Amsterdam, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands. ial.burgers@vumc.nl.
authors.forename: Ingrid A L
authors.initials: IA
authors.lastname: Burgers-Bots
authors.affiliation: Department of Psychiatry, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands. s.rutten@vumc.nl.
authors.forename: Sonja
authors.initials: S
authors.lastname: Rutten
authors.affiliation: Department of Rehabilitation Medicine, MOVE Research Institute Amsterdam, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands. g.kwakkel@vumc.nl.
authors.forename: Gert
authors.initials: G
authors.lastname: Kwakkel
authors.affiliation: Parkinson Vereniging, Postbus 46, 3980 CA, Bunnik, The Netherlands. vermunt.kees@gmail.com.
authors.forename: Kees
authors.initials: K
authors.lastname: Vermunt
authors.affiliation: Parkinson Vereniging, Postbus 46, 3980 CA, Bunnik, The Netherlands. b.van.vliet@xs4all.nl.
authors.forename: Bep
authors.initials: B
authors.lastname: van Vliet
authors.affiliation: Neuroscience Campus Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. h.berendse@vumc.nl.|Department of Neurology, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. h.berendse@vumc.nl.
authors.forename: Henk W
authors.initials: HW
authors.lastname: Berendse
authors.affiliation: Department of Rehabilitation Medicine, MOVE Research Institute Amsterdam, VU University Medical Center, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands. e.vanwegen@vumc.nl.
authors.forename: Erwin E H
authors.initials: EE
authors.lastname: van Wegen
mesh_terms: D001007:Anxiety / Q000209:etiology / Q000628:therapy*; D001364:Awareness; D002985:Clinical Protocols; D006801:Humans; D007980:Levodopa / Q000009:adverse effects*; D017063:Outcome Assessment, Health Care; D010300:Parkinson Disease / Q000188:drug therapy*; D026741:Physical Therapy Modalities; D018401:Sample Size; D016037:Single-Blind Method
chemical_list: D007980:Levodopa