Mindfulness-based cognitive therapy in functional dyspepsia: A pilot randomized trial.
Study Goal
The researchers aimed to evaluate the feasibility and efficacy of Mindfulness-Based Cognitive Therapy (MBCT) in managing functional dyspepsia (FD) symptoms.
Results Summary
MBCT showed a trend toward symptom improvement in FD, with 90% of participants reporting better subjective-clinical-assessment scores compared to 45% in the control group. Significant improvements were noted in dyspepsia-specific and psychological distress measures, though general health and quality-of-life scores remained unchanged.
Population
28 patients meeting ROME-III criteria for functional dyspepsia.
Effective Dosage
8-week MBCT program (specific frequency not detailed).
Duration
8 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-based cognitive therapy (MBCT) | decrease | subjective-clinical-assessment of FD symptoms (SCA-FD) | patients fulfilling ROME-III criteria for FD | 90% reporting improvement | trend towards symptom improvement | #1 |
Mindfulness-based cognitive therapy (MBCT) | decrease | Short-form Nepean Dyspepsia Index (SF-NDI) | patients fulfilling ROME-III criteria for FD | mean change: -8.8 (SD: 7.5) vs -0.7 (7.2) | greater improvement | #2 |
Mindfulness-based cognitive therapy (MBCT) | decrease | Depression, Anxiety and Stress Scale-21 Items (DASS-21) | patients fulfilling ROME-III criteria for FD | -19.8 (29.5) vs -5.5 (6.6) | greater improvement | #3 |
Mindfulness-based cognitive therapy (MBCT) | no change | subjective-clinical-assessment of general health (SCA-GH) | patients fulfilling ROME-III criteria for FD | - | no difference | #4 |
Mindfulness-based cognitive therapy (MBCT) | no change | EuroQoL-Visual Analog Scale (EuroQoL-VAS) | patients fulfilling ROME-III criteria for FD | - | no difference | #5 |
BACKGROUND AND AIM: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: Mindfulness-based cognitive therapy is likely efficacious for FD, and it would be feasible to conduct a RCT.