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

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...

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Veröffentlicht in:Journal of gastroenterology and hepatology 2021-08, Vol.36 (8), p.2058-2066
Hauptverfasser: Teh, Kevin Kim‐Jun, Ng, Yi‐Kang, Doshi, Kinjal, Tay, Shu‐Wen, Hao, Ying, Ang, Lui‐Yee, Foong, Henry Lew‐Yuen, Ong, Andrew Ming‐Liang, Siah, Kewin Tien‐Ho, Chan, Webber Pak‐Wo, Ong, Wai‐Choung, Mesenas, Steven Joseph, Lim, Chee‐Hooi, Wang, Yu‐Tien
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container_end_page 2066
container_issue 8
container_start_page 2058
container_title Journal of gastroenterology and hepatology
container_volume 36
creator Teh, Kevin Kim‐Jun
Ng, Yi‐Kang
Doshi, Kinjal
Tay, Shu‐Wen
Hao, Ying
Ang, Lui‐Yee
Foong, Henry Lew‐Yuen
Ong, Andrew Ming‐Liang
Siah, Kewin Tien‐Ho
Chan, Webber Pak‐Wo
Ong, Wai‐Choung
Mesenas, Steven Joseph
Lim, Chee‐Hooi
Wang, Yu‐Tien
description 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.
doi_str_mv 10.1111/jgh.15389
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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.</description><identifier>ISSN: 0815-9319</identifier><identifier>EISSN: 1440-1746</identifier><identifier>DOI: 10.1111/jgh.15389</identifier><identifier>PMID: 33373492</identifier><language>eng</language><publisher>Australia: Wiley Subscription Services, Inc</publisher><subject>Anxiety ; Clinical trials ; Cognitive ability ; Cognitive Behavioral Therapy ; Cognitive therapy ; Dyspepsia ; Dyspepsia - therapy ; Gastrointestinal diseases ; Humans ; Mental depression ; Mindfulness ; Patients ; Pilot Projects ; psychological intervention ; Psychotherapy, Group ; Treatment Outcome</subject><ispartof>Journal of gastroenterology and hepatology, 2021-08, Vol.36 (8), p.2058-2066</ispartof><rights>2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd</rights><rights>2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd.</rights><rights>2021 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4199-b9558bf09560701ee7c721d3a50250025d42e425f8dc588531920616912f710e3</citedby><cites>FETCH-LOGICAL-c4199-b9558bf09560701ee7c721d3a50250025d42e425f8dc588531920616912f710e3</cites><orcidid>0000-0001-8832-9561 ; 0000-0002-9199-2038 ; 0000-0002-2795-5101 ; 0000-0002-8884-3381</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjgh.15389$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjgh.15389$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33373492$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Teh, Kevin Kim‐Jun</creatorcontrib><creatorcontrib>Ng, Yi‐Kang</creatorcontrib><creatorcontrib>Doshi, Kinjal</creatorcontrib><creatorcontrib>Tay, Shu‐Wen</creatorcontrib><creatorcontrib>Hao, Ying</creatorcontrib><creatorcontrib>Ang, Lui‐Yee</creatorcontrib><creatorcontrib>Foong, Henry Lew‐Yuen</creatorcontrib><creatorcontrib>Ong, Andrew Ming‐Liang</creatorcontrib><creatorcontrib>Siah, Kewin Tien‐Ho</creatorcontrib><creatorcontrib>Chan, Webber Pak‐Wo</creatorcontrib><creatorcontrib>Ong, Wai‐Choung</creatorcontrib><creatorcontrib>Mesenas, Steven Joseph</creatorcontrib><creatorcontrib>Lim, Chee‐Hooi</creatorcontrib><creatorcontrib>Wang, Yu‐Tien</creatorcontrib><title>Mindfulness‐based cognitive therapy in functional dyspepsia: A pilot randomized trial</title><title>Journal of gastroenterology and hepatology</title><addtitle>J Gastroenterol Hepatol</addtitle><description>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). 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Ng, Yi‐Kang ; Doshi, Kinjal ; Tay, Shu‐Wen ; Hao, Ying ; Ang, Lui‐Yee ; Foong, Henry Lew‐Yuen ; Ong, Andrew Ming‐Liang ; Siah, Kewin Tien‐Ho ; Chan, Webber Pak‐Wo ; Ong, Wai‐Choung ; Mesenas, Steven Joseph ; Lim, Chee‐Hooi ; Wang, Yu‐Tien</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4199-b9558bf09560701ee7c721d3a50250025d42e425f8dc588531920616912f710e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Anxiety</topic><topic>Clinical trials</topic><topic>Cognitive ability</topic><topic>Cognitive Behavioral Therapy</topic><topic>Cognitive therapy</topic><topic>Dyspepsia</topic><topic>Dyspepsia - therapy</topic><topic>Gastrointestinal diseases</topic><topic>Humans</topic><topic>Mental depression</topic><topic>Mindfulness</topic><topic>Patients</topic><topic>Pilot Projects</topic><topic>psychological intervention</topic><topic>Psychotherapy, Group</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Teh, Kevin Kim‐Jun</creatorcontrib><creatorcontrib>Ng, Yi‐Kang</creatorcontrib><creatorcontrib>Doshi, Kinjal</creatorcontrib><creatorcontrib>Tay, Shu‐Wen</creatorcontrib><creatorcontrib>Hao, Ying</creatorcontrib><creatorcontrib>Ang, Lui‐Yee</creatorcontrib><creatorcontrib>Foong, Henry Lew‐Yuen</creatorcontrib><creatorcontrib>Ong, Andrew Ming‐Liang</creatorcontrib><creatorcontrib>Siah, Kewin Tien‐Ho</creatorcontrib><creatorcontrib>Chan, Webber Pak‐Wo</creatorcontrib><creatorcontrib>Ong, Wai‐Choung</creatorcontrib><creatorcontrib>Mesenas, Steven Joseph</creatorcontrib><creatorcontrib>Lim, Chee‐Hooi</creatorcontrib><creatorcontrib>Wang, Yu‐Tien</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Teh, Kevin Kim‐Jun</au><au>Ng, Yi‐Kang</au><au>Doshi, Kinjal</au><au>Tay, Shu‐Wen</au><au>Hao, Ying</au><au>Ang, Lui‐Yee</au><au>Foong, Henry Lew‐Yuen</au><au>Ong, Andrew Ming‐Liang</au><au>Siah, Kewin Tien‐Ho</au><au>Chan, Webber Pak‐Wo</au><au>Ong, Wai‐Choung</au><au>Mesenas, Steven Joseph</au><au>Lim, Chee‐Hooi</au><au>Wang, Yu‐Tien</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mindfulness‐based cognitive therapy in functional dyspepsia: A pilot randomized trial</atitle><jtitle>Journal of gastroenterology and hepatology</jtitle><addtitle>J Gastroenterol Hepatol</addtitle><date>2021-08</date><risdate>2021</risdate><volume>36</volume><issue>8</issue><spage>2058</spage><epage>2066</epage><pages>2058-2066</pages><issn>0815-9319</issn><eissn>1440-1746</eissn><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 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.</abstract><cop>Australia</cop><pub>Wiley Subscription Services, Inc</pub><pmid>33373492</pmid><doi>10.1111/jgh.15389</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-8832-9561</orcidid><orcidid>https://orcid.org/0000-0002-9199-2038</orcidid><orcidid>https://orcid.org/0000-0002-2795-5101</orcidid><orcidid>https://orcid.org/0000-0002-8884-3381</orcidid></addata></record>
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subjects Anxiety
Clinical trials
Cognitive ability
Cognitive Behavioral Therapy
Cognitive therapy
Dyspepsia
Dyspepsia - therapy
Gastrointestinal diseases
Humans
Mental depression
Mindfulness
Patients
Pilot Projects
psychological intervention
Psychotherapy, Group
Treatment Outcome
title Mindfulness‐based cognitive therapy in functional dyspepsia: A pilot randomized trial
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