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Discontinuation of antidepressant medication in primary care supported by monitoring plus mindfulness-based cognitive therapy versus monitoring alone: design and protocol of a cluster randomized controlled trial

机译:监测加基于正念的认知疗法与单独监测相比,支持在初级保健中停用抗抑郁药:一项随机对照试验的设计和方案

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Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners (GPs). Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care. This study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12?months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of SPD and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0?mg) within 6?months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs. In theory, stopping antidepressant medication seems straightforward. In practice however, patients and their GPs appear reluctant to initiate and accomplish this process. Both patients and professionals are in need of appropriate tools and information to better support the process of discontinuing antidepressant medication. ClinicalTrials.gov PRS ID: NCT03361514 retrospectively registered October 2017.
机译:抗抑郁药的使用持续增长,这主要是由于接受长期治疗的患者比例增加。尽管治疗指南建议在持续缓解后停用,但抗抑郁药的停用对于患者和全科医生(GPs)均具有挑战性。基于正念的认知疗法(MBCT)是一种有效的干预措施,可以降低复发性抑郁症复发的风险,并可以通过教导患者应对戒断症状和对复发的恐惧感来促进戒断。目前的研究旨在调查支持的协议性停药(SPD)和MBCT相较于单独使用SPD在成功终止长期在基层医疗中长期使用抗抑郁药的有效性。这项研究包括一项对长期护理抗抑郁药的基层护理患者进行的基线随机对照研究,基线治疗分别为基线,6、9和12个月。选择中止药物治疗的患者将获得SPD和MBCT或SPD的组合。我们的主要结果是在基线评估后的6个月内完全停用抗抑郁药(= 0 mg)。次要结果指标是戒断症状的严重程度,抑郁和焦虑症状,心理健康,生活质量以及医疗和社会成本。从理论上讲,停止抗抑郁药的治疗似乎很简单。然而,实际上,患者及其全科医生似乎不愿意启动和完成此过程。病人和专业人员都需要适当的工具和信息,以更好地支持抗抑郁药的停药过程。 ClinicalTrials.gov PRS ID:NCT03361514于2017年10月追溯注册。

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