The Danish Research Centre for Chemical Sensitivities, Department of Dermato-Allergology, Copenhagen University Hospital Gentofte, Ledreborg Alle 40, 2th, Gentofte 2820, Copenhagen, Denmark.
Trials. 2012 Sep 27;13:179. doi: 10.1186/1745-6215-13-179.
Multiple chemical sensitivity (MCS) is a condition characterized by recurrent, self-reported symptoms from multiple organ systems, attributable to exposure to a wide range of chemically unrelated substances at low levels. The pathophysiology is unknown, and affected individuals generally favor avoidance of the symptom triggering substances as a coping strategy. The impact of MCS on daily life may thus be severe. An intervention that may effectively reduce the impact of MCS, alleviate the symptoms and the psychological distress associated with the condition is therefore highly needed. In this study we will assess the effects of a mindfulness-based cognitive (MBCT) program on MCS.
METHODS/DESIGN: Using a randomized controlled design (RCT), we will compare MBCT with treatment as usual (TAU). The MBCT intervention will include 8 weekly 2.5 hour sessions, and 45 minutes of mindfulness home practice 6 days each week. Participants will be asked to complete questionnaires at baseline, post-treatment, and at 6 and 12 months' follow-up. Based on sample size estimation, 82 participants will be randomized to either the MBCT intervention or to TAU. The primary outcome will be a measure of the impact of MCS on the participants' lives. The secondary outcome measures are physical symptoms of psychological distress, perceived stress, illness perceptions, QOL, and work ability. Lastly, we will assess whether any effect of MBCT on the primary effect measure is mediated by level of mindfulness, self-compassion, perceived stress, and rumination.
This trial will provide important information on the effects of MBCT on MCS.
Clinical trials identifier NCT01240395.
多种化学敏感性 (MCS) 是一种以多个器官系统反复发作、自我报告的症状为特征的疾病，归因于暴露于低水平的广泛无关联化学物质。其病理生理学尚不清楚，受影响的个体通常倾向于避免接触引起症状的物质作为应对策略。因此，MCS 对日常生活的影响可能很严重。因此，非常需要一种能够有效减轻 MCS 影响、缓解与该病症相关的症状和心理困扰的干预措施。在这项研究中，我们将评估基于正念的认知 (MBCT) 方案对 MCS 的影响。
方法/设计：使用随机对照设计 (RCT)，我们将比较 MBCT 与常规治疗 (TAU)。MBCT 干预包括 8 周每周 2.5 小时的课程，以及每周 6 天每天 45 分钟的正念家庭练习。参与者将被要求在基线、治疗后以及 6 个月和 12 个月的随访时完成问卷。根据样本量估算，将有 82 名参与者被随机分配到 MBCT 干预组或 TAU 组。主要结局指标将是 MCS 对参与者生活影响的衡量标准。次要结局指标是身体症状、心理困扰、感知压力、疾病认知、生活质量和工作能力。最后，我们将评估 MBCT 对主要效果测量的任何影响是否通过正念、自我同情、感知压力和反刍的水平来介导。
这项试验将提供关于 MBCT 对 MCS 的影响的重要信息。
临床试验标识符 NCT01240395。
