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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.

Ghielen I, van den Heuvel OA, de Goede CJ, Houniet-de Gier M, Collette EH, Burgers-Bots IA, Rutten S, Kwakkel G, Vermunt K, van Vliet B, Berendse HW, van Wegen EE - Trials (2015)

Bottom Line: During this phenomenon, motor symptoms such as rigidity and freezing re-emerge.This study will investigate whether this new intervention, named BEWARE, is more effective than treatment as usual in increasing self-efficacy.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands. i.ghielen@vumc.nl.

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/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.

No MeSH data available.


Related in: MedlinePlus

Study flow chart. BEWARE body awareness training, PD Parkinson’s disease, TAU treatment as usual
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Fig1: Study flow chart. BEWARE body awareness training, PD Parkinson’s disease, TAU treatment as usual

Mentions: This will be a single-blind randomized controlled trial. Thirty-six PD patients who experience WRA will be randomly allocated either to the BEWARE training group (n = 18, three groups of six patients) or to a control group receiving physical group therapy, which is a usual form of treatment for wearing-off in patients with PD at the VU University Medical Center (n = 18, three groups of six patients). Block randomization is done by using concealed opaque envelopes. All participants are asked to maintain the regular medication schedule during the 6-week intervention. Assessments are conducted prior to the intervention and at 6 weeks directly after the intervention. Also, long-term effects will be assessed at 18 weeks of follow-up (from post-enrolment). The assessments will be performed by a blinded investigator who is not involved in the intervention or randomization. Figure 1 demonstrates the study design according to the CONSORT (Consolidated Standards of Reporting Trials) statement [33].Fig. 1


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.

Ghielen I, van den Heuvel OA, de Goede CJ, Houniet-de Gier M, Collette EH, Burgers-Bots IA, Rutten S, Kwakkel G, Vermunt K, van Vliet B, Berendse HW, van Wegen EE - Trials (2015)

Study flow chart. BEWARE body awareness training, PD Parkinson’s disease, TAU treatment as usual
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4489048&req=5

Fig1: Study flow chart. BEWARE body awareness training, PD Parkinson’s disease, TAU treatment as usual
Mentions: This will be a single-blind randomized controlled trial. Thirty-six PD patients who experience WRA will be randomly allocated either to the BEWARE training group (n = 18, three groups of six patients) or to a control group receiving physical group therapy, which is a usual form of treatment for wearing-off in patients with PD at the VU University Medical Center (n = 18, three groups of six patients). Block randomization is done by using concealed opaque envelopes. All participants are asked to maintain the regular medication schedule during the 6-week intervention. Assessments are conducted prior to the intervention and at 6 weeks directly after the intervention. Also, long-term effects will be assessed at 18 weeks of follow-up (from post-enrolment). The assessments will be performed by a blinded investigator who is not involved in the intervention or randomization. Figure 1 demonstrates the study design according to the CONSORT (Consolidated Standards of Reporting Trials) statement [33].Fig. 1

Bottom Line: During this phenomenon, motor symptoms such as rigidity and freezing re-emerge.This study will investigate whether this new intervention, named BEWARE, is more effective than treatment as usual in increasing self-efficacy.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands. i.ghielen@vumc.nl.

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/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.

No MeSH data available.


Related in: MedlinePlus