Mindfulness-based cognitive therapy for multiple chemical sensitivity: a study protocol for a randomized controlled trial

基于正念的认知疗法治疗多种化学物质过敏症:一项随机对照试验的研究方案

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Abstract

BACKGROUND: 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. DISCUSSION: This trial will provide important information on the effects of MBCT on MCS. TRIALS REGISTRATION: Clinical trials identifier NCT01240395.

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