G A S T R O E N T E R O L O G Y
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* and Yu-Tien Wang*
*Department of Gastroenterology and Hepatology,‡Department of Psychology,¶Behavioral Medicine Unit, Singapore General Hospital,†Department of General Medicine, Sengkang General Hospital,§Health Services Research Centre, Singapore Health Services, **Department of Gastroenterology and Hepatology, Department of Medicine, National University Hospital and††Department of Medicine, Yong Loo Lin School of Medicine, The National University of Singapore, Singapore
Key words
cognitive behavioral therapy, dyspepsia, mindfulness, psychological intervention.
Accepted for publication 23 December 2020.
Correspondence
Yi-Kang Ng, Department of General Medicine, Sengkang General Hospital, 110 Sengkang East Way, Singapore 544886.
Email: [email protected] Kevin Kim-Jun Teh and Yi-Kang Ng contributed equally asfirst authors.
Declaration of conflict of interest:All authors have nofinancial disclosures related to the conduct of this study.
Author contribution:K.K.J. Teh, Y.K. Ng, K.
Doshi, and Y.T. Wang did the conception and design, data acquisition, data analysis and interpretation, drafting of manuscript, revision of manuscript andfinal approval of manuscript.
L.Y. Ang and H.L.Y. Foong carried out the conception and design, data acquisition, and final approval of manuscript. S.W. Tay, Y. Hao, A.M.L. Ong, K.T.H. Siah, W.P.W. Chan, W.C.
Ong, S.J. Mesenas, and C.H. Lim did the data analysis and interpretation, drafting of manuscript, revision of manuscript, andfinal approval of manuscript.
Financial support:This study has been supported by the Singapore General Hospital New Investigator Grant SRG-NIG#14/2017 from the SGH Division of Research.
Abstract
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 compli- ance 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 improve- ment 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.
Introduction
Functional dyspepsia (FD) is a chronic functional gastrointestinal (GI) disorder with estimated global prevalence of 7%.1 Patients with functional GI disorders (FGIDs) often have concomitant anx- iety and depression.2Anxiety is a complex concept3 combining sense uncontrollability towards future negative events with
self-focus on one’s inadequate capabilities to cope. Psychosocial stressors precede symptom exacerbation, with Asians being more likely to express psychological distress as physical complaints.4 Cognitive behavioral therapy (CBT) is the most established psy- chological intervention for FGIDs. It is problem-focused, action- orientated and culturally congruent with the expectations of doi:10.1111/jgh.15389
therapy in Asians.5It is resource intensive,6requires multiple ses- sions of individual therapy, and may not be feasible for large-scale adoption, especially in centers with high patient-turnover and limited staffing.7
Studies evaluating mindfulness-based therapies (MBT) suggest efficacy in FGIDs, with consistent improvement in disease-related quality-of-life (QoL).8MBT teaches participants to develop mind- fulness, using meditation and relaxation to maintain their attention on present experiences without judgment.9,10A specific type of MBT, mindfulness-based cognitive therapy (MBCT), is a group-skills program combining strategies from CBT and MBT, aimed at integrating adaptive thought-processes and decreasing maladaptive thought-content.11,12MBCT utilizes secular mindful- ness techniques and disengages participants from perpetuating habitual dysfunctional cognitive routines, such as ruminative and negative thought-patterns. MBCT allows greater operational efficiency compared with CBT, given multiple patients can benefit during the same session. MBCT has been shown to improve symptoms in irritable bowel syndrome.13 To our knowledge, evidence on its efficacy in other FGIDs is lacking. There have been no randomized controlled trials (RCTs) evaluating MBCT in FD management.
We hypothesize that MBCT will reduce severity of FD symp- toms compared with treatment-as-usual (TAU) in Asians, given the aspects of psychological therapy it encompasses and addresses.
We conducted a pilot randomized trial to test feasibility (recruit- ment and retention rates) and efficacy of a MBCT program in FD management.
Methods
Patient selection and randomization. We conducted a mixed-method unblinded single-center pilot randomized parallel trial, with consecutive recruitment of patients attending the gastro- enterology clinic in a tertiary hospital in Singapore. Recruitment was conducted from June to December 2017. We included English-speaking adult patients (≥18 years) who fulfilled ROME-III criteria for FD14 with normal upper GI evaluation (endoscopic or radiological). They were excluded if they had any psychiatric illness, activeHelicobacter pyloriinfection inflamma- tory bowel disease, gastrointestinal malignancy, acute liver or pan- creatic disease, previous abdominal trauma or surgery involving gastrointestinal resection, active pregnancy, any change in psycho- tropic medications in the preceding 3 months or any condition that would prevent them from participation in group therapy.
Sample size calculation was not performed in our pilot study. A target of 15 patients per group, taking into account drop-outs, was chosen based on the ideal group size for mindfulness-based inter- personally oriented interventions.15The group size was optimal to provide the critical mass needed for validation of different viewpoints and sufficient time for participants to understand one another.
Informed consent was obtained, and the study protocol was ap- proved by the Singapore Health Services Centralized Institutional Review Board. Our study investigated a behavioral intervention, which did not require registration into a clinical trial registry according to FDAAA 801 and the Final Rule. Patients were given information about the group-based MBCT program and the
expected level of participation. They were informed that they would either be randomized into MBCT or TAU, with reassur- ances given that participation would not negatively impact clinical management. They were given the option of not participating and receiving psychological therapy directly. Patients who agreed to participate were randomized with 1:1 allocation ratio by means of block randomization, with assignment in sealed envelopes prepared by non-study team members.
All authors had access to the study data, reviewed, and approved thefinal manuscript.
Questionnaires. All participants completed questionnaires at baseline and at week 8 (Fig. 1).
The primary outcome was change in patients’ subjective assessment of their FD symptoms, measured by Subjective- Clinical-Assessment–FD (SCA-FD). Secondary outcomes included subjective assessment of their general-health (GH), measured Subjective-Clinical-Assessment–GH (SCA-GH),16 FD-specific and general QoL and emotional state.
Subjective-Clinical-Assessment–FD and SCA-GH were utilized by Orive et al. to evaluate efficacy of psychotherapy in FD.
Patients were asked to decide if they felt much better, quite a lot better, somewhat better, about the same, somewhat worse, quite a lot worse or much worse in relation to their FD symptoms and GH. A response was considered positive if the patient reported feeling much or somewhat better. All other responses were considered negative. While not validated in FD, improvements in SCA were consistent with improvements in two FD-specific ques- tionnaires—Glasgow Dyspepsia Severity Score and Dyspepsia Related Health Scale.16
Functional dyspepsia-specific QoL was assessed using the 10-item short form17 of the Nepean Dyspepsia Index (SF-NDI) GH-related QoL was measured using the EuroQoL-Visual Analog Scale (EuroQoL-VAS).18Emotional state was measured using the Depression, Anxiety and Stress Scale–21 Items (DASS-21).19 Participation satisfaction was evaluated using the Client Satisfac- tion Questionnaire (CSQ-8). Further details are included in the Supporting Information.
Mindfulness based cognitive therapy. The MBCT program consisted of eight weekly 2-h sessions with one half-day retreat after the sixth session. The program was facilitated by the same qualified mindfulness instructors throughout, with an average of 88 h of experience leading mindfulness-based courses and 780 h of personal practice. The program outline is shown in Table 1. Participants were provided weekly handouts and links to audiotracks for home-practice. They were required to complete a worksheet documenting their self-practice between sessions, which were reviewed and returned with feedback.
Focus group. Two focus-groups were conducted during the retreat to explore expectations and perceptions of the program.
Opinions on the benefits of attending and recommendations on program-design were discussed. Thefirst group consisted offive participants who completed six of eight sessions (experienced group). The second group consisted of six participants from TAU (naïve group). Using an interview schedule, the focus group
was conducted by one of the authors (KD), accompanied by a different note-taker at each focus-group. Discussions were audio- recorded, transcribed verbatim, and analyzed independently using directed content analysis. Study design and reporting were in accordance with the“consolidate criteria for reporting qualitative research (COREQ)”checklist.20
Feasibility assessments. Feasibility of recruitment was assessed by the number of patients who were approached and agreed to participate.
Acceptability of randomization and procedures was evaluated by the number patients who dropped-out or were lost to follow- up, assessed at the point of randomization and at week 8.
Acceptability of treatment was determined based on the number of MBCT sessions attended. CSQ-8 was utilized to assess partici- pant satisfaction and to assess treatment acceptability.
Handout compliance was determined by the number of completed handouts received, and the number who dropped out of the study citing constraints relating to self-practice.
Feasibility of quantitative measures was determined by the amount of time required to complete all questionnaires and the number of patients who did not complete all questionnaires at baseline and week 8.
Qualitative feedback on all feasibility assessment aspects was obtained during focus-group sessions.
Treatment-as-usual. We adopted a pragmatic randomiza- tion design with TAU as the comparator with replicate clinical practice. Utilization of TAU ensured that no patients were negatively affected by participation in the study.21Treatment was neither delayed nor were patients denied access to ongoing clinical service. Participation and patient retention have been reported to be more favorable with TAU as the comparator.
Statistical analysis. Data were examined to ensure that they were normally distributed and met assumptions for parametric statistical tests. All outcome variables were approximately normally distributed. Paired and unpaired Studentt-tests were used for parametric quantitative data, and Wilcoxon signed-rank test for nonparametric quantitative data. Fisher’s exact test was used to compare categorical variables. Differences were considered signif- icant when P-value was <0.05. Per-protocol analysis was performed. All statistical tests were performed using SPSS17.0 (SPSS Inc. Chicago, IL) and R.
Results
Feasibility of recruitment. The consort diagram is shown in Figure 1. Of 54 eligible patients approached, 28 consented to participate; they completed baseline questionnaires and were ran- domized to MBCT (n= 15) or TAU (n= 13). This study was Figure 1 CONSORT diagram. MBCT,
mindfulness-based cognitive therapy; TAU, treat- ment-as-usual.
conducted by the Gastroenterology Department of a single tertiary referral center in Singapore, which sees on average 1500 outpa- tients per month (approximately 50% evaluated and managed for dyspepsia). Potential participants were identified during clinic visits.
We completed recruitment for the MBCT group on schedule, despite 50% of patients declining to participate. We believe this was due to inadequate understanding MBCT during a telephone conversation. This was higher in comparison with other studies which reported rejection rates of between 10–20%.16,22This can be addressed having a dedicated consultation by a study-team member.
Cultural factors like stigma against psychological therapy4 could also account for the high number of patients who declined to participate. A further 20% of eligible patients could not partici- pate because they could not converse in English, the medium of instruction.
Acceptability of randomization and procedures.
No patients dropped out of the study at the time of randomization.
Three patients randomized to MBCT and two patients randomized to TAU were lost to follow-up at week 8.
Acceptability of treatment. Among the 15 participants who underwent MBCT, three dropped-out (two citing time com- mitments and one citing difficulty following instructions), placing the drop-out rate at 20%. There were no reported adverse side-effects or harm resulting from participation in MBCT. The remaining 12 participants attended all MBCT and focus-group sessions. As with previously published studies on psychological therapy for FGIDs, we were limited by incomplete outcome data due to drop-outs. Nonetheless, the drop-out rate we experienced was comparable.16,22Across mindfulness studies, the attrition rate is moderate23at 16%, compared with 20%24with CBT.
Table 1 Outline of the mindfulness-based cognitive behavioral therapy (MBCT) program
Session Title Lessons/practice
1 Automatic pilot Awarenessversusautopilot
Raisin exercise Body scan practice
2 Dealing with barriers Body scan practice
Mindfulness of the breath 10 min sitting meditation Thoughts and feeling exercise Pleasant experience calendar
3 Mindfulness of the breath and body Seeing/hearing exercise
30 min sharing meditation 3 min breathing space Unpleasant experience calendar
4 Staying present Automatic thoughts questionnaire
Seeing/hearing exercise 30 min sitting meditation Mindful walking
5 Allowing/letting be Sitting meditation
Using the breathing space
6 Thoughts are not facts Sitting meditation
Ways you can see your thoughts Differently
Relapse prevention
Working wisely with unhappiness and Depression-I Stepping back from thought
The train of associations
Retreat Day of mindfulness
7 How can I best take of myself Sitting meditation–noticing how we related to
working wisely with unhappiness and Depression-I Our experiences
The exhaustion funnel Schedule activities
Working wisely with unhappiness and Depression-II Relapse prevention
8 Using what has been learned to deal with future Body scan
Review
Discussion on how to maintain practice
Handout compliance. Two patients in MBCT dropped-out citing time commitments. Feedback from the patients who com- pleted the program suggests the schedule (weekly for 2.5 h on a weekday) and the daily minimum commitment of 30 min may have contributed. Nonetheless, the 12 patients who completed MBCT were compliant in completing weekly handouts.
Feasibility of quantitative measures. Baseline ques- tionnaires were completed by all 28 patients. At week 8, 22 pa- tients completed all questionnaires. One patient in MBCT did not complete CSQ-8.
The time required to complete the baseline questionnaires was 30 min. Patients with difficulty understanding selected questions were given translation assistance. While all patients included were able to understand written English, we do not anticipate language to hinder data collection as the key questionnaires are available in multiple languages. SCA-FD and SCA-GH involve only one ques- tion each and is easily translated.
Primary outcome. There were no significant differences in demographics and symptom severity at baseline among patients in both groups (Table 2). Mean SF-NDI, EuroQoL-VAS, and DASS-21 scores at baseline were also similar. No patients were initiated on psychotropic medications during the study duration.
Effects of mindfulness-based cognitive therapy on subjec- tive-clinical-assessment. Two patients who completed MBCT elected not to respond to SCA-FD. Nine of the remaining 10 pa- tients in MBCT had improvement in SCA-FD compared withfive out of 11 in TAU (Table 3), with a trend towards significance
(P= 0.063). There was no significant difference between the two groups in SCA-GH (P= 0.65).
Secondary outcomes
Effects on Short-form Nepean Dyspepsia Index, EuroQoL-Visual Analog Scale, and Depression, Anxiety and Stress Scale–21 Items. Patients in MBCT reported significant improvement in SF-NDI compared with TAU (mean change 8.8 (SD: 7.5)vs 0.7 (7.2),P= 0.018) (Table 4). They reported reduction in mean DASS-21 total score as well as within both depression and stress sub-categories. There was however no significant difference when compared with TAU ( 19.8 (29.5) vs 5.5 (6.6), P = 0.13). There were no significant changes in the EuroQoL-VAS or the DASS-anxiety sub scores. Overall changes in mean SF-NDI score for both MBCT and TAU groups are shown in Figure 2a. Change in individual patient SF-NDI, DASS-21 scores, and EuroQoL-VAS scores in both groups are shown in Figure 2b–d.
Patient satisfaction. Ten patients completed the CSQ-8 ques- tionnaire, with 90% responding positively (overall score≥32).
Focus group findings. Illustrative quotations from the focus-group sessions are shown in Table 5. All participants viewed MBCT as an alternate strategy that may complement existing ther- apy. They hoped to have some form of recovery after attending the program, particularly where medications had limited efficacy or caused side-effects. They also hoped MBCT would help them bet- ter understand the contributors to their symptoms.
Table 2 Comparison of MBCT and TAU group participants at baseline
MBCT group (n= 15) TAU group (n= 13) P-value
Age (years), mean (SD) 49.0 (15.5) 48.2 (12.9) 0.89
Gender (female), % 40.0 53.8 0.72
Race (Chinese), % 86.7 84.6 0.78
SF-NDI, mean (SD) 26.2 (9.7) 23.9 (10.8) 0.57
EuroQoL-VAS, mean (SD) 57.6 (21.0) 65.4 (16.0) 0.28
DASS-21, mean (SD) 43.2 (34.9) 35.1 (27.0) 0.49
DASS-21, Depression, Anxiety and Stress Scale–21 items; EuroQoL-VAS, EuroQoL-Visual Analog Scale; MBCT, mindfulness-based cognitive therapy;
SD, standard deviation; SF-NDI, 10-item short form of the Nepean Dyspepsia Index; TAU, treatment-as-usual.
Table 3 Effect on subjective clinical assessment
Total (n= 21) MBCT (n= 10) TAU (n= 11) P-value SCA-FD In relation to your functional dyspepsia do you:
feel better,n(%) 14 (50) 9 (90) 5 (45) 0.063
feel the same or worse,n(%) 7 (25) 1 (10) 6 (55)
Total (n=22) MBCT (n=11) TAU (n=11) p-value
SCA-GH In relation to your health in general, do you:
feel better,n(%) 14 (64) 8 (73) 6 (55) 0.659
feel the same or worse,n(%) 8 (36) 3 (27) 5 (45)
MBCT, mindfulness-based cognitive therapy; SCA-FD, subjective clinical assessment of functional dyspepsia symptoms; SCA-GH, subjective clinical assessment of general health; TAU, treatment-as-usual.
Experienced participants highlighted that the program provided skills to better manage their FD. They emphasized how they learned to recognize thoughts, feelings and bodily sensations, in- cluding their experience of stress. They were able to better manage their stress and consequently their FD symptoms. They were able to reduce their reliance on medications. Participating in group-therapy afforded them increased social-support by reducing the loneliness and isolation they experienced.
All participants expressed having uncertainties about MBCT.
They acknowledged that a better understanding of what the pro- gram entailed would have better prepared them. This caused con- cerns regarding conflicting schedules and required commitment levels.
The importance of having proper guidance within and outside of the sessions was highlighted by both groups; they believed it aided
their understanding of the practices and encouraged continued practice after the program. Experienced participants highlighted the importance of group-dynamics on their motivation to engage in-session and suggested that only individuals who were willing to commit to the program be invited.
Discussion
Ourfindings suggest that it is feasible to conduct a definitive RCT evaluating MBCT in the management of FD in a single tertiary re- ferral center in Asia. Ourfindings also suggest that MBCT is po- tentially efficacious, with a trend towards significance in SCA-FD and statistically significant improvement in SF-NDI. It provides patients and physicians a complementary approach to Table 4 Effect on SF-NDI, EuroQoL-VAS, and DASS-21
MBCT Within MBCT (P-value) TAU Within TAU (P-value) Between groups (P-value)
Change in SF-NDI, mean (SD) 8.8 (7.5) 0.003 0.7 (7.2) 0.75 0.02
Change in EuroQoL-VAS, mean (SD) 6.2 (18.6) 0.27 6.7 (15.7) 0.19 0.95
Change in DASS-21, mean (SD) 19.8 (29.5) 0.04 5.5 (6.6) 0.02 0.13
Change in DASS–Depression, mean (SD) 3.2 (4.8) 0.04 0.6 (1.7) 0.26 0.11
Change in DASS–Anxiety, mean (SD) 2.3 (5.4) 0.16 0.5 (2) 0.38 0.30
Change in DASS–Stress, mean (SD) 4.4 (5.8) 0.02 1.5 (2.9) 0.11 0.15
DASS-21, Depression, Anxiety and Stress Scale–21 items; EuroQoL-VAS, EuroQoL-Visual Analog Scale; MBCT, mindfulness-based cognitive therapy;
SD, standard deviation; SF-NDI, 10-item short form of the Nepean Dyspepsia Index; TAU, treatment-as-usual.
Figure 2 (a) Overall change in mean SF-NDI scores. (b) Change in individual SF-NDI scores. (c) Change in individual DASS-21 scores. (d) Change in EuroQoL-VAS scores. (a)▪▪▪, MBCT;▪▪▪, treatment-as-usual.
managing FD. Furthermore, this study highlighted the patient’s ex- perience, including aspects that would improve its future conduct.
Ninety percent of patients in the MBCT group reported improvement in SCA-FD. This is comparable with the initial study by Orive et al.16 The difference did not reach statistical signifi- cance as this pilot study was not adequately powered. There was statistically significant improvement in SF-NDI scores, with mean change of 8.8 (effect size 1.33, 95% CI 13.8, 3.8). This fell short of the improvement in SF-NDI score required to correspond to clinically meaningful change in patient status25, which we attri- bute to the small patient numbers. However, the distinct improve- ment in symptoms measured by SCA-FD and SF-NDI observed in the MBCT group is encouraging, supporting our hypothesis that MBCT would be efficacious.
The reduction in DASS-21 scores of patients who underwent MBCT is promising and clinically significant. Reduction in depression may be attributed to a reduction in rumination and worry, which are widely accepted to perpetuate and intensify depression.26 Participants identified that learning self-regulation of thoughts and emotions was beneficial; studies suggest that mindfulness practice develops the participants’ability to observe their thoughts non-judgmentally and not react in a reflexive manner.27This ability to self-regulate one’s thoughts and emotions alleviates depression. Similarly, participants highlighted the rela- tionship between worry, stress, and their physical FD symptoms.
This supports the body of research suggesting that MBCT may be effective in reducing FD symptoms28 through control of anxiety, depression, and stress.
Participants who underwent MBCT reported significant improvement in their FD-specific QoL, without translating to overall QoL. Participants could have focused the application of
MBCT strategies and exercises only towards FD, without applying them to other aspects of life.
Experience of mindfulness-based cognitive ther- apy. Subjectively, participants of the MBCT program found it efficacious. The program enlightened them on the potential trig- gers for their symptoms. Together with the exercises to address these triggers and manage the experience of symptoms, partici- pants regained a sense of control. Studies have shown that provid- ing education alone is insufficient in enabling patients to care for their chronic medical conditions. Training them to use skills that can address the issues they face, and in so, offering them a sense of agency is more effective in helping them manage their condition.29
Limitations. Our study only recruited English-speaking pa- tients. Our data were collected at the end of the 8-week program, and we were not able to evaluate sustainability of symptom improvement. We anticipate that patients would continue applying techniques learnt during the program in their daily routine.28We aim to address this in the eventual RCT, where patients will be followed-up for 6 months after completion of MBCT. Patients in TAU did not subsequently undergo MBCT. TAU was used as the control measure in our study, potentially resulting in performance bias. Our sample size was small and underpowered to detect differ- ences in subgroup analyses and potential patient factors that could affect the efficacy of MBCT. In addition, our study included patients who fulfilled ROME-III criteria for FD, regardless of symptom severity. Despite these limitations, this is thefirst pilot randomized study evaluating MBCT in FD management.
Table 5 Illustrative quotations by theme from data generated by participants Illustrative quotations
1.0 Theme: Expectations and Perceptions of the Program
1.1 Subtheme: Alternative approach to addressing functional dyspepsia symptoms
“I hate taking all the medications…the side effects there…”[experienced group, #1]
“…see what other things can be done. Because, taking pain killers, doing all this doesn’t really help…see if there’s anything I can learn from. It’s good to, self-help myself.”[naïve group, #2]
1.2 Subtheme: Management of stressors “…it looks like my mood can control my guts”[naïve group, #5]
“…learn to distress from pain”[experienced group, #4]
2.0 Theme: Benefits of participating in program 2.1 Subtheme: Better management of functional dyspepsia symptoms
“I was taking a lot of medication, for acid reflux. Gradually after 6 weeks it reduced” “It’s working for me, I want to be living proof that it works”[experienced group, #1]
“after 6 weeks…I gradually reduced off my medications for bloating and heart burn” [experienced group, #3]
2.2 Subtheme: Increased social support “…people in the class, better to get to know them, we are not alone.”[experienced group, #1]
3.0 Theme: Recommendations for the program 3.1. Subtheme: Addressing the uncertainties of the program
“Just like you go for a course…what you learn, topics, this is what you get. So it’s very clear.
Maybe a one-page understanding would be good for everybody”[naïve group, #2]
“Have to go through thefirst roundfirst to know actually what’s the hassle like…will not know until the veryfirst week”[naïve group, #3]
3.2. Subtheme: Continued guidance “Need people to guide me. We need to have more opportunities to practice with others.” [experienced group, #5]
3.3. Subtheme: Group dynamics “Have a criteria to select people who are genuine so that we can benefit as a group. To keep the morale.”[experienced group, #2]
“Great value to identify people who would stay throughout the program, otherwise it would be a waste of resources and decrease in morale”[experienced group, #3]
Future considerations. Using our primary outcome measure (SCA-FD), the eventual RCT will require 50 patients in total (25 in each group) to detect an effect size of 0.47 with 90%
power at 5% significance level, factoring a 20% dropout rate.
When conducting the eventual RCT, more information on base- line characteristics of patient’s recruited should be obtained to evaluate for potential confounders. A consideration would be to recruit patients fulfilling the latest ROME criteria of FD who report moderate to severe intensity of FD-related symptoms.
Selecting patients with more significant impairment in FD-specific QoL, represented by higher SF-NDI scores may be beneficial in showing the efficacy of MBCT.
Utilization of an active control group involving psychoeducation and/or supportive therapy with similar sessions can be considered. The eventual program should incorporate mate- rial that specifically addresses the participants’concerns regarding FD; similar tailored mindfulness-based programs have been created for depression, sleep disorders, and cancer recovery.
Participants highlighted the need for a study team representative to act as a contact person during the program. The tailored program will also need to take into account the duration of time, amount of practice and type of mindfulness skills taught to partic- ipants, which may improve participation, practice and application.
Our center is in the process of training psychologists and clinicians to facilitate the conduct of MBCT programs in other commonly spoken languages.
Conclusions
This pilot randomized trial has demonstrated that it is feasible to conduct a full RCT evaluating MBCT in the management patients with FD. Our data suggests MBCT is likely to be efficacious FD management. Future considerations for an RCT evaluating MBCT in FD management have been proposed.
Acknowledgments
The authors would like to acknowledge the contributions of Lavanya Sugumar and Stacey Lee Henderson for qualitative data acquisition and analysis for focus group transcripts.
References
1 Vakil NB, Howden CW, Moayyedi P, Tack J. White paper AGA:
functional dyspepsia.Clin. Gastroenterol. Hepatol.2017;15: 1191–4.
2 Aro P, Talley NJ, Johansson S-E, Agréus L, Ronkainen J. Anxiety is linked to new-onset dyspepsia in the Swedish population: a 10-year follow-up study.Gastroenterology2015;148: 928–37.
3 Barlow DH, Chorpita BF, Turovsky J. Fear, panic, anxiety, and disorders of emotion.Neb. Symp. Motiv. Neb. Symp. Motiv.1996;43:
251–328.
4 Kramer EJ, Kwong K, Lee E, Chung H. Cultural factors influencing the mental health of Asian Americans.West. J. Med.2002;176:
227–31.
5 Tang J, Li C, Rogers R, Ballou M. Effectiveness of cognitive behavioral therapy with Asian American patients in an acute psychiatric partial hospital program. North.Am. J. Med. Sci.2015;8: 6.
6 Palsson OS, Whitehead WE. Psychological treatments in functional gastrointestinal disorders: a primer for the gastroenterologist.Clin.
Gastroenterol. Hepatol.2013;11: 208–16.
7 Kramer TL, Burns BJ. Implementing cognitive behavioral therapy in the real world: a case study of two mental health centers.Implement Sci.2008; 29;3: 14.
8 Zernicke KA, Campbell TS, Blustein PKet al. Mindfulness-based stress reduction for the treatment of irritable bowel syndrome symptoms: a randomized wait-list controlled trial.Int. J. Behav. Med.
2013;20: 385–96.
9 Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being.J. Pers. Soc. Psychol.2003;84:
822–48.
10 Kabat-Zinn J. Mindfulness-based interventions in context:
past, present, and future.Clin. Psychol. Sci. Pract.2003;10: 144–56.
11 Williams JMG, Russell I, Russell D. Mindfulness-based cognitive therapy.J. Consult. Clin. Psychol.2008;76: 524–9.
12 Segal ZV, Teasdale JD, Williams JMG. Mindfulness-based cognitive therapy: theoretical rationale and empirical status. In:Mindfulness and acceptance: expanding the cognitive-behavioral tradition. New York, NY, US: Guilford Press, 2004; 45–65.
13 Henrich JF, Gjelsvik B, Surawy C, Evans E, Martin M. A randomized clinical trial of mindfulness-based cognitive therapy for women with irritable bowel syndrome-effects and mechanisms.J. Consult. Clin.
Psychol.2020;88: 295–310.
14 Tack J, Talley NJ, Camilleri Met al. Functional gastroduodenal disorders.Gastroenterology2006;130: 1466–79.
15 Schroevers MJ, Tovote KA, Snippe E, Fleer J. Group and individual mindfulness-based cognitive therapy (MBCT) are both effective: a pilot randomized controlled trial in depressed people with a somatic disease.Mind2016;7: 1339–46.
16 Orive M, Barrio I, Orive VMet al. A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia.J. Psychosom. Res.
2015;78: 563–8.
17 Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form.Aliment. Pharmacol. Ther.
2001;15: 207–16.
18 Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group.Ann. Med.2001;33: 337–43.
19 Antony MM, Bieling PJ, Cox BJ, Enns MW, Swinson RP.
Psychometric properties of the 42-item and 21-item versions of the depression anxiety stress scales in clinical groups and a community sample.Psychol. Assess.1998;10: 176–81.
20 Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.International J. Qual. Health Care2007;19: 349–57.
21 Kazdin AE. Treatment as usual and routine care in research and clinical practice.Clin. Psychol. Rev.2015;42: 168–78.
22 Hamilton J, Guthrie E, Creed Fet al. A randomized controlled trial of psychotherapy in patients with chronic functional dyspepsia.
Gastroenterology2000 Sep;119: 661–9.
23 Khoury B, Lecomte T, Fortin Get al. Mindfulness-based therapy: a comprehensive meta-analysis.Clin. Psychol. Rev.2013;33: 763–71.
24 Westbrook D, Kirk J. The clinical effectiveness of cognitive behaviour therapy: outcome for a large sample of adults treated in routine practice.Behav. Res. Ther.2005;43: 1243–61.
25 Jones M, Talley NJ. Minimum clinically important difference for the Nepean Dyspepsia Index, a validated quality of life scale for functional dyspepsia.Am. J. Gastroenterol.2009;104: 1483–8.
26 Raes F. Rumination and worry as mediators of the relationship between self-compassion and depression and anxiety.Personal. Individ. Differ.
2010;48: 757–61.
27 Baer RA. Self-focused attention and mechanisms of change in mindfulness-based treatment.Cogn. Behav. Ther.2009;38: 15–20.
28 Gaylord SA, Palsson OS, Garland ELet al. Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial.Am. J. Gastroenterol.2011;106: 1678–88.
29 Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient
self-management of chronic disease in primary care.JAMA2002 Nov 20;288: 2469–75.
Supporting information
Additional supporting information may be found online in the Supporting Information section at the end of the article.
Data S1.Supporting information
