由监测加正念认知疗法支持的初级保健中抗抑郁药物停药与单独监测的比较：一项集群随机对照试验的设计和方案。
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.
机构信息
Department of Psychiatry, Radboud University Medical Center, Postbus 9101, 6500 HB, Nijmegen, the Netherlands.
Department of Primary and Community Care, Radboud University Medical Center, Postbus 9101, 6500 HB, Nijmegen, the Netherlands.
出版信息
BMC Fam Pract. 2019 Jul 26;20(1):105. doi: 10.1186/s12875-019-0989-5.
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov PRS ID: NCT03361514 retrospectively registered October 2017.
背景
抗抑郁药的使用持续增加，主要原因是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药，但对于患者和全科医生（GP）来说，停药似乎具有挑战性。基于正念认知疗法（MBCT）是一种有效的干预措施，可降低复发性抑郁症复发的风险，并通过教患者应对停药症状和对复发的恐惧，从而有助于停药。本研究旨在调查支持方案停药（SPD）联合 MBCT 与 SPD 单独治疗在初级保健中长期使用抗抑郁药成功停药方面的有效性。
方法
这是一项在初级保健中长期使用抗抑郁药的患者中进行的集群随机对照试验，基线和 6、9 和 12 个月时进行随访评估。选择停药的患者将接受 SPD 联合 MBCT 或 SPD 单独治疗。我们的主要结局将是在基线评估后 6 个月内完全停止抗抑郁药物（= 0mg）。次要结局指标将是停药症状的严重程度、抑郁和焦虑症状、心理幸福感、生活质量以及医疗和社会成本。
讨论
从理论上讲，停止抗抑郁药似乎很简单。但实际上，患者及其 GP 似乎不愿意开始和完成这一过程。患者和专业人员都需要适当的工具和信息来更好地支持停药过程。
试验注册
ClinicalTrials.gov PRS ID：NCT03361514 于 2017 年 10 月回顾性注册。
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