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Mindfulness-based cognitive therapy in functional dyspepsia: A pilot randomized trial.

Kevin Kim-Jun Teh, Yi-Kang Ng, Kinjal Doshi, Shu-Wen Tay, Ying Hao, Lui-Yee Ang, Henry Lew-Yuen Foong, Andrew Ming-Liang Ong, Kewin Tien-Ho Siah, Webber Pak-Wo Chan, Wai-Choung Ong, Steven Joseph Mesenas, Chee-Hooi Lim, Yu-Tien Wang

Journal of gastroenterology and hepatology August 2021 DOI: 10.1111/jgh.15389 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Pilot randomized controlled trial (mixed-method, single-center) Peer reviewed
Sample size 28
Population Patients meeting ROME-III criteria for functional dyspepsia
Intervention Mindfulness-based cognitive therapy (MBCT)
Duration 8-week intervention, with questionnaires at baseline and week 8
Measures Subjective-clinical-assessment of FD symptoms (SCA-FD), Short-form Nepean Dyspepsia Index (SF-NDI), subjective-clinical-assessment of general health (SCA-GH), EuroQoL-Visual Analog Scale (EuroQoL-VAS), Depression, Anxiety and Stress Scale-21 Items (DASS-21)
Topics Meditation
Keywords Cognitive behavioral therapy Dyspepsia Psychological intervention
Key findings MBCT showed a non-significant trend toward dyspepsia symptom improvement (90% vs 45% reporting improvement, P=0.063) and significantly greater improvement on the Short-form Nepean Dyspepsia Index (mean change -8.8 vs -0.7, P=0.018) compared with treatment-as-usual. Depression, anxiety, and stress scores improved more in the MBCT group but not significantly, and general health and quality-of-life measures showed no difference. The authors conclude MBCT is likely efficacious for functional dyspepsia and that a full randomized trial would be feasible.

Abstract

Patients with functional dyspepsia (FD) often have concomitant anxiety and depression. Mindfulness-based cognitive therapy (MBCT) combines the principles of cognitive behavioral therapy and mindfulness. It is a group-based therapy and has been shown to be efficacious in functional gastrointestinal disorders. There are no randomized controlled trials (RCTs) evaluating MBCT in FD. We aimed to evaluate feasibility and efficacy of MBCT in FD management. We performed a mixed-method single-center pilot randomized trial of 28 patients fulfilling ROME-III criteria for FD. Fifteen patients were randomized to an 8-week MBCT program while 13 underwent treatment-as-usual (TAU). Patients completed questionnaires at baseline and at week 8. Two focus-groups were conducted. Feasibility of recruitment, acceptability of randomization, procedures and intervention, handout compliance and feasibility of quantitative measures were assessed. The primary outcome was subjective-clinical-assessment of FD symptoms (SCA-FD). Secondary outcome measures included Short-form Nepean Dyspepsia Index (SF-NDI), subjective-clinical-assessment of general health (SCA-GH), EuroQoL-Visual Analog Scale (EuroQoL-VAS), and Depression, Anxiety and Stress Scale-21 Items (DASS-21). Twelve of 15 patients in the MBCT group completed the program. There was a trend towards symptom improvement, with 90% in the MBCT group reporting improvement in SCA-FD compared with 45% in TAU(P = 0.063). Patients who underwent MBCT reported greater improvement in SF-NDI (mean change: -8.8 (SD: 7.5) vs -0.7 (7.2), P = 0.018) and DASS-21 (-19.8 (29.5) vs -5.5 (6.6) P = 0.13) compared with TAU. There was no difference in SCA-GH and EuroQoL-VAS. Based on SCA-FD improvement, the eventual RCT will require 50 patients (25 in each group). Mindfulness-based cognitive therapy is likely efficacious for FD, and it would be feasible to conduct a RCT.

Comparable studies

Other randomized controlled trials on meditation, most cited first.

Study Year Design Participants
Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment 2003 Randomized controlled trial n = 41
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults 2008 Randomized controlled trial n = 139
Short-term meditation training improves attention and self-regulation Undergraduate Chinese students 2007 Randomized controlled trial n = 40
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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