Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Primary and Community Care, Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
PLoS One. 2023 Sep 5;18(9):e0290965. doi: 10.1371/journal.pone.0290965. eCollection 2023.
Discontinuing antidepressant medication (ADM) can be challenging for patients and clinicians. In the current study we investigated if Mindfulness-Based Cognitive Therapy (MBCT) added to supported protocolized discontinuation (SPD) is more effective than SPD alone to help patients discontinue ADM. This study describes a prospective, cluster-randomized controlled trial (completed). From 151 invited primary care practices in the Netherlands, 36 (24%) were willing to participate and randomly allocated to SPD+MBCT (k = 20) or SPD (k = 16). Adults using ADM > 9 months were invited by GPs to discuss tapering, followed by either MBCT+SPD, or SPD alone. Exclusion criteria included current psychiatric treatment; substance use disorder; non-psychiatric indication for ADM; attended MBCT within past 5 years; cognitive barriers. From the approximately 3000 invited patients, 276 responded, 119 participated in the interventions and 92 completed all assessments. All patients were offered a decision aid and a personalized tapering schedule (with GP). MBCT consisted of eight group sessions of 2.5 hours and one full day of practice. SPD was optional and consisted of consultations with a mental health assistant. Patients were assessed at baseline and 6, 9 and 12 months follow-up, non-blinded. In line with our protocol, primary outcome was full discontinuation of ADM within 6 months. Secondary outcomes were depression, anxiety, withdrawal symptoms, rumination, well-being, mindfulness skills, and self-compassion. Patients allocated to SPD + MBCT (n = 73) were not significantly more successful in discontinuing (44%) than those allocated to SPD (n = 46; 33%), OR 1.60, 95% CI 0.73 to 3.49, p = .24, number needed to treat = 9. Only 20/73 allocated to MBCT (27%) completed MBCT. No serious adverse events were reported. In conclusion, we were unable to demonstrate a significant benefit of adding MBCT to SPD to support discontinuation in general practice. Actual participation in patient-tailored interventions was low, both for practices and for patients. (Trial registration: ClinicalTrials.gov PRS ID: NCT03361514 registered December 2017).
停止使用抗抑郁药物（ADM）对患者和临床医生来说都是一个挑战。在目前的研究中，我们调查了正念认知疗法（MBCT）是否比单纯的支持性方案停药（SPD）更有效，以帮助患者停止使用 ADM。本研究描述了一项前瞻性、集群随机对照试验（已完成）。从荷兰邀请的 151 家初级保健诊所中，有 36 家（24%）愿意参与，并随机分配到 SPD+MBCT（k = 20）或 SPD（k = 16）。接受 ADM 治疗>9 个月的成年人被全科医生邀请讨论逐渐减少用药，随后要么接受 MBCT+SPD，要么单独接受 SPD。排除标准包括目前的精神科治疗；物质使用障碍；非精神科 ADM 指征；过去 5 年内接受过 MBCT；认知障碍。在大约 3000 名受邀患者中，有 276 人做出了回应，119 人参加了干预措施，92 人完成了所有评估。所有患者都获得了决策辅助工具和个性化的减药计划（与全科医生一起）。MBCT 由 8 个 2.5 小时的小组课程和 1 天的实践课程组成。SPD 是可选的，包括与心理健康助理的咨询。患者在基线和 6、9 和 12 个月时进行评估，不设盲法。根据我们的方案，主要结果是在 6 个月内完全停止使用 ADM。次要结果是抑郁、焦虑、戒断症状、沉思、幸福感、正念技能和自我同情。分配到 SPD+MBCT（n = 73）的患者在停药方面（44%）并不比分配到 SPD（n = 46；33%）的患者更成功，OR 1.60，95%CI 0.73 至 3.49，p =.24，需要治疗的人数 = 9。只有 73 名分配到 MBCT 的患者中的 20 名（27%）完成了 MBCT。没有报告严重不良事件。总之，我们无法证明在一般实践中添加 MBCT 以支持停药对 SPD 有显著益处。实际参与量身定制的干预措施的患者和实践都很少。（试验注册：ClinicalTrials.gov PRS ID：NCT03361514，于 2017 年 12 月注册）。
