注意：帕金森病患者“剂末现象”相关焦虑症治疗中的身体觉知训练：一项随机对照试验的研究方案

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.

作者信息

Ghielen Ires, van den Heuvel Odile A, de Goede Cees J T, Houniet-de Gier Marieke, Collette Emma H, Burgers-Bots Ingrid A L, Rutten Sonja, Kwakkel Gert, Vermunt Kees, van Vliet Bep, Berendse Henk W, van Wegen Erwin E H

机构信息

Department of Psychiatry, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.

Department of Anatomy & Neurosciences, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.

出版信息

Trials. 2015 Jun 23;16:283. doi: 10.1186/s13063-015-0804-0.

DOI:10.1186/s13063-015-0804-0

PMID:26101038

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4489048/

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.

摘要

背景

帕金森病（PD）患者的剂末现象是长期使用左旋多巴的一种并发症。在此现象期间，诸如僵硬和冻结等运动症状会再次出现。这通常伴有非运动症状，包括焦虑，即所谓的剂末相关焦虑（WRA）。当前的治疗选择有限，通常侧重于剂末现象的身体或心理方面。为了最佳地应对这些方面之间复杂的相互作用，一种综合方法似乎是必要的。此外，由于剂末现象最终是不可避免的，治疗需要侧重于应对、接受和自我效能感。因此，我们开发了一种综合身体意识干预措施，将物理治疗的原则与接受与承诺疗法相结合，以教导患者应对WRA。本研究将调查这种名为BEWARE的新干预措施在提高自我效能感方面是否比常规治疗更有效。

方法/设计：这是一项针对36名经历WRA的PD患者的单盲随机对照试验。研究对象将从VU大学医学中心运动障碍门诊招募。在提供书面知情同意书后，患者将被随机分配到实验组（BEWARE）或常规治疗组（物理治疗）。临床评估将在干预前、6周干预期结束后以及3个月自然随访期由未参与研究的盲法研究者进行。主要结局指标是自我效能感，次要结局指标侧重于运动能力、日常功能、焦虑和生活质量。