基于正念的认知疗法及随访对药物治疗难治性焦虑症的有效性：一项可行性随机对照试验方案
Effectiveness of Mindfulness-Based Cognitive Therapy With Follow-Up Sessions for Pharmacotherapy-Refractory Anxiety Disorders: Protocol for a Feasibility Randomized Controlled Trial.
作者信息
Sado Mitsuhiro, Ninomiya Akira, Nagaoka Maki, Koreki Akihiro, Goto Naho, Sasaki Yohei, Takamori Chie, Kosugi Teppei, Yamada Masashi, Park Sunre, Sato Yasunori, Fujisawa Daisuke, Nakagawa Atsuo, Mimura Masaru
机构信息
Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Center for Stress Research, Keio University, Tokyo, Japan.
出版信息
JMIR Res Protoc. 2022 Jan 21;11(1):e33776. doi: 10.2196/33776.
BACKGROUND
Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported to be effective after treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear.
OBJECTIVE
This study aims to examine the feasibility, acceptability, and effectiveness of a follow-up program by conducting a feasibility randomized controlled trial (RCT) that compares augmented MBCT with follow-up sessions and that without follow-up sessions in preparation for a definitive RCT.
METHODS
The study involves an 8-week MBCT with a 10-month follow-up. Patients aged 20 to 65 years who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for panic disorder, agoraphobia, or social anxiety disorder, which is not remitted with usual treatment for at least 4 weeks, will be included in the study and randomly allocated to receive augmented MBCT with follow-up sessions or augmented MBCT without follow-up sessions. For this feasibility RCT, the primary outcomes are (1) study inclusion rate, (2) dropout rate, (3) attendance rate, and (4) mean and standard deviation of several clinical measures at 8 weeks and 5, 8, and 12 months.
RESULTS
We started recruiting participants in January 2020, and 43 participants have been enrolled up to January 2021. The study is ongoing, and data collection will be completed by May 2022.
CONCLUSIONS
This study is novel in terms of its design, which compares augmented MBCT with and without follow-up sessions. The limitations of the trial are as follows: (1) mixed participants in terms of the delivery mode of the intervention, and (2) lack of a pharmacotherapy-alone arm. Owing to its novelty and significance, this study will provide fruitful knowledge for future definitive RCTs.
TRIAL REGISTRATION
UMIN Clinical Trials Registry UMIN000038626; https://tinyurl.com/2p9dtxzh.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33776.
背景
据报道，强化正念认知疗法（MBCT）联合常规治疗（主要是药物治疗）对焦虑症治疗有效。然而，其长期有效性尚不清楚。
目的
本研究旨在通过开展一项可行性随机对照试验（RCT），比较有随访 sessions 的强化 MBCT 和无随访 sessions 的强化 MBCT，以检验随访项目的可行性、可接受性和有效性，为确定性 RCT 做准备。
方法
本研究包括为期 8 周的 MBCT 和 10 个月的随访。年龄在 20 至 65 岁之间、符合《精神障碍诊断与统计手册》第 4 版（DSM-IV）中惊恐障碍、广场恐惧症或社交焦虑障碍标准且常规治疗至少 4 周未缓解的患者将纳入研究，并随机分配接受有随访 sessions 的强化 MBCT 或无随访 sessions 的强化 MBCT。对于这项可行性 RCT，主要结局指标为：（1）研究纳入率；（2）脱落率；（3）出勤率；（4）8 周以及 5、8 和 12 个月时多项临床指标的均值和标准差。
结果
我们于 2020 年 1 月开始招募参与者，截至 2021 年 1 月已招募 43 名参与者。研究正在进行中，数据收集将于 2022 年 5 月完成。
结论
本研究在设计上具有创新性，比较了有随访 sessions 和无随访 sessions 的强化 MBCT。该试验的局限性如下：（1）干预实施方式的参与者混杂；（2）缺乏单纯药物治疗组。由于其新颖性和重要性，本研究将为未来的确定性 RCT 提供丰富的知识。
试验注册
UMIN 临床试验注册库 UMIN000038626；https://tinyurl.com/2p9dtxzh。
国际注册报告识别码（IRRID）：DERR1-10.2196/33776。
Zotero 插件