JMIR Publications

ABSTRACT

Background:

Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported as effective post 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 the follow-up program by conducting a feasibility randomized controlled trial (RCT) to compare the augmented MBCT with follow-up and that without follow-up in preparation for a definitive RCT.

Methods:

We conducted an eight-week RCT with a ten-month follow-up. Patients aged 20–65 years who met the DSM-IV criteria for panic disorder, agoraphobia, or social anxiety disorder, not remitted with the usual treatment for at least four weeks were included in the study and randomly allocated to the augmented MBCT with follow-up sessions or the augmented MBCT without the follow-up sessions. For this feasibility RCT, the primary outcomes were 1) study inclusion rate, 2) dropout rate, 3) attendance rate, and 4) mean and standard deviation of the several clinical measures at 8 weeks and 5, 8, and 12 months.

Results:

We started recruiting participants in January 2020. The study is ongoing, and data collection will be completed by May 2022.

Conclusions:

This study is novel in terms of the 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 delivery mode of the intervention, and 2) lack of a pharmacotherapy-alone arm. For its novelty and significance, this study will bring fruitful knowledge to future definitive RCTs. Clinical Trial: UMIN Clinical Trials Registry: UMIN000038626. Registered November 19, 2019.