Effectiveness of Mindfulness-Based Cognitive Therapy With Follow-Up Sessions for Pharmacotherapy-Refractory Anxiety Disorders: Protocol for a Feasibility Randomized Controlled Trial.

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.
(©Mitsuhiro Sado, Akira Ninomiya, Maki Nagaoka, Akihiro Koreki, Naho Goto, Yohei Sasaki, Chie Takamori, Teppei Kosugi, Masashi Yamada, Sunre Park, Yasunori Sato, Daisuke Fujisawa, Atsuo Nakagawa, Masaru Mimura. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.01.2022.)