Effectiveness of Mindfulness-Based Cognitive Therapy With Follow-Up Sessions for Pharmacotherapy-Refractory Anxiety Disorders: Protocol for a Feasibility Randomized Controlled Trial
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
JMIR Research Protocols August 28, 2023 DOI: 10.2196/33776 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Feasibility randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 43 |
| Population | Adults aged 20–65 with panic disorder, agoraphobia, or social anxiety disorder not remitted after at least 4 weeks of usual treatment |
| Duration | 8-week intervention, 10-month follow-up |
| Topics | Anxiety Meditation |
| Key findings | The study is ongoing and no results are reported; it assesses feasibility outcomes to inform a future definitive RCT. |
Abstract
BackgroundAugmented 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. ObjectiveThis 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. MethodsThe 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. ResultsWe 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. ConclusionsThis 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 RegistrationUMIN Clinical Trials Registry UMIN000038626; https://tinyurl.com/2p9dtxzh International Registered Report Identifier (IRRID)DERR1-10.2196/33776
Comparable studies
Other randomized controlled trials on anxiety, most cited first.
Citations in the library
Cites 11
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse Psychotherapy Research March 1, 2003
- A Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression Psychotherapy and Psychosomatics 2016
- Effectiveness of mindfulness‐based cognitive therapy in patients with anxiety disorders in secondary‐care settings: A randomized controlled trial Psychiatry and Clinical Neurosciences November 27, 2019
- Practice of Therapy Acquired Regulatory Skills and Depressive Relapse/Recurrence Prophylaxis Following Cognitive Therapy or Mindfulness Based Cognitive Therapy Journal of Consulting and Clinical Psychology February 1, 2019
and 6 more in the library