General Practice Clinical Unit, Medical School, The University of Queensland, Herston, Brisbane, QLD, 4072, Australia.
NHS Foundation Trust, Research and Development Department, London, Northeast London, UK.
Trials. 2023 Sep 28;24(1):615. doi: 10.1186/s13063-023-07646-w.
Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 12 months). Long-term antidepressant use is increasing internationally yet is not recommended for most people. Long-term use is associated with adverse effects including weight gain, sexual dysfunction, lethargy, emotional numbing and increased risk of falls and fractures. This study aims to determine the effectiveness of two multi-strategy interventions (RELEASE and RELEASE+) in supporting the safe cessation of long-term antidepressants, estimate cost-effectiveness, and evaluate implementation strategies.
DESIGN: 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1.
primary care general practices in southeast Queensland, Australia.
adults 18 years or older taking antidepressants for longer than 1 year. Practices will be randomised on a 1.5:1:1 ratio of Usual care:RELEASE:RELEASE+.
RELEASE for patients includes evidence-based information and resources and an invitation to medication review; RELEASE for GPs includes education, training and printable resources via practice management software. RELEASE+ includes additional internet support for patients and prescribing support including audit and feedback for GPs.
the primary outcome is antidepressant use at 12 months self-reported by patients. Cessation is defined as 0 mg antidepressant maintained for at least 2 weeks.
at 6 and 12 months are health-related quality of life, antidepressant side effects, well-being, withdrawal symptoms, emotional numbing, beliefs about antidepressants, depressive symptoms, and anxiety symptoms; and at 12 months 75% reduction in antidepressant dose; aggregated practice level antidepressant prescribing, and health service utilisation for costs.
653 patients from 28 practices. A concurrent evaluation of implementation will be through mixed methods including interviews with up to 40 patients and primary care general practitioners, brief e-surveys, and study administrative data to assess implementation outcomes (adoption and fidelity).
The RELEASE study will develop new knowledge applicable internationally on the effectiveness, cost-effectiveness, and implementation of two multi-strategy interventions in supporting the safe cessation of long-term antidepressants to improve primary health care and outcomes for patients.
ANZCTR, ACTRN12622001379707p. Registered on 27 October 2022.
许多人在试图停止使用抗抑郁药时会出现戒断症状。戒断症状很容易被误解为复发或持续需要药物治疗，从而导致长期使用（>12 个月）。国际上抗抑郁药的长期使用正在增加，但不建议大多数人使用。长期使用会导致不良反应，包括体重增加、性功能障碍、嗜睡、情绪麻木以及跌倒和骨折的风险增加。本研究旨在确定两种多策略干预措施（RELEASE 和 RELEASE+）在支持安全停用长期抗抑郁药方面的有效性，估计成本效益，并评估实施策略。
设计：3 臂实用集群随机对照试验有效性-实施混合类型 1。
澳大利亚昆士兰州东南部的基层医疗保健全科医生诊所。
服用抗抑郁药超过 1 年的 18 岁或以上成年人。将按 1.5:1:1 的比例对常规护理、RELEASE 和 RELEASE+进行随机分组。
RELEASE 为患者提供循证信息和资源，并邀请进行药物审查；RELEASE 为全科医生提供教育、培训和通过实践管理软件提供可打印资源。RELEASE+为患者提供额外的互联网支持，并为全科医生提供处方支持，包括审计和反馈。
患者在 12 个月时报告的抗抑郁药使用情况是主要结局。停药定义为至少 2 周维持 0mg 抗抑郁药。
6 个月和 12 个月时的健康相关生活质量、抗抑郁药副作用、幸福感、戒断症状、情绪麻木、对抗抑郁药的信念、抑郁症状和焦虑症状；以及 12 个月时抗抑郁药剂量减少 75%；汇总实践水平的抗抑郁药处方和卫生服务利用情况以评估成本。
来自 28 个实践的 653 名患者。同时进行实施情况的评估，将通过混合方法进行，包括对多达 40 名患者和初级保健全科医生进行访谈、简短的电子调查以及研究管理数据，以评估实施结果（采用和一致性）。
RELEASE 研究将开发新的知识，适用于国际上支持安全停用长期抗抑郁药的两种多策略干预措施的有效性、成本效益和实施情况，以改善初级保健和患者的结果。
ANZCTR，ACTRN12622001379707p。于 2022 年 10 月 27 日注册。
