Guided Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial
Background:Individual face-to-face cognitive behavioral therapy is known to be effective for bulimia nervosa (BN). Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy...
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| creator | Hamatani, Sayo Matsumoto, Kazuki Andersson, Gerhard Tomioka, Yukiko Numata, Shusuke Kamashita, Rio Sekiguchi, Atsushi Sato, Yasuhiro Fukudo, Shin Sasaki, Natsuki Nakamura, Masayuki Otani, Ryoko Sakuta, Ryoichi Hirano, Yoshiyuki Kosaka, Hirotaka Mizuno, Yoshifumi |
| description | Background:Individual face-to-face cognitive behavioral therapy is known to be effective for bulimia nervosa (BN). Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT.Objective:This paper presents a research protocol for strategies to examine the effects of guided ICBT.Methods:This study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis.Results:This study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022.Conclusions:This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN.Trial Registration:University Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522International Registered Report Identifier (IRRID):DERR1-10.2196/49828 |
| doi_str_mv | 10.2196/49828 |
| format | Article |
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Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT.Objective:This paper presents a research protocol for strategies to examine the effects of guided ICBT.Methods:This study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis.Results:This study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022.Conclusions:This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN.Trial Registration:University Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522International Registered Report Identifier (IRRID):DERR1-10.2196/49828</description><identifier>ISSN: 1929-0748</identifier><identifier>EISSN: 1929-0748</identifier><identifier>DOI: 10.2196/49828</identifier><identifier>PMID: 37725414</identifier><language>eng</language><publisher>Toronto: JMIR Publications</publisher><subject>Anxiety ; Behavior modification ; Binge eating ; Body image ; Bulimia ; Clinical trials ; Communication ; Eating disorders ; Females ; Hospitals ; Information technology ; Informed consent ; Internet access ; Intervention ; Literacy ; Medicin och hälsovetenskap ; Mental disorders ; Mental health ; Post traumatic stress disorder ; Protocol ; Questionnaires ; Self image ; Therapists ; Therapy ; Women</subject><ispartof>JMIR research protocols, 2023-01, Vol.12, p.e49828-e49828</ispartof><rights>2023. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Sayo Hamatani, Kazuki Matsumoto, Gerhard Andersson, Yukiko Tomioka, Shusuke Numata, Rio Kamashita, Atsushi Sekiguchi, Yasuhiro Sato, Shin Fukudo, Natsuki Sasaki, Masayuki Nakamura, Ryoko Otani, Ryoichi Sakuta, Yoshiyuki Hirano, Hirotaka Kosaka, Yoshifumi Mizuno. 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Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT.Objective:This paper presents a research protocol for strategies to examine the effects of guided ICBT.Methods:This study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis.Results:This study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022.Conclusions:This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN.Trial Registration:University Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522International Registered Report Identifier (IRRID):DERR1-10.2196/49828</description><subject>Anxiety</subject><subject>Behavior modification</subject><subject>Binge eating</subject><subject>Body image</subject><subject>Bulimia</subject><subject>Clinical trials</subject><subject>Communication</subject><subject>Eating disorders</subject><subject>Females</subject><subject>Hospitals</subject><subject>Information technology</subject><subject>Informed consent</subject><subject>Internet access</subject><subject>Intervention</subject><subject>Literacy</subject><subject>Medicin och hälsovetenskap</subject><subject>Mental 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Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial</title><author>Hamatani, Sayo ; Matsumoto, Kazuki ; Andersson, Gerhard ; Tomioka, Yukiko ; Numata, Shusuke ; Kamashita, Rio ; Sekiguchi, Atsushi ; Sato, Yasuhiro ; Fukudo, Shin ; Sasaki, Natsuki ; Nakamura, Masayuki ; Otani, Ryoko ; Sakuta, Ryoichi ; Hirano, Yoshiyuki ; Kosaka, Hirotaka ; Mizuno, Yoshifumi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c495t-e2c5dc7de925584e856033ac44bc566ff7951298fcd16f1580037c30712208173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Anxiety</topic><topic>Behavior modification</topic><topic>Binge eating</topic><topic>Body image</topic><topic>Bulimia</topic><topic>Clinical trials</topic><topic>Communication</topic><topic>Eating disorders</topic><topic>Females</topic><topic>Hospitals</topic><topic>Information technology</topic><topic>Informed consent</topic><topic>Internet access</topic><topic>Intervention</topic><topic>Literacy</topic><topic>Medicin och hälsovetenskap</topic><topic>Mental disorders</topic><topic>Mental health</topic><topic>Post traumatic stress disorder</topic><topic>Protocol</topic><topic>Questionnaires</topic><topic>Self image</topic><topic>Therapists</topic><topic>Therapy</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hamatani, Sayo</creatorcontrib><creatorcontrib>Matsumoto, Kazuki</creatorcontrib><creatorcontrib>Andersson, Gerhard</creatorcontrib><creatorcontrib>Tomioka, Yukiko</creatorcontrib><creatorcontrib>Numata, Shusuke</creatorcontrib><creatorcontrib>Kamashita, Rio</creatorcontrib><creatorcontrib>Sekiguchi, Atsushi</creatorcontrib><creatorcontrib>Sato, Yasuhiro</creatorcontrib><creatorcontrib>Fukudo, 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Controlled Trial</atitle><jtitle>JMIR research protocols</jtitle><date>2023-01-01</date><risdate>2023</risdate><volume>12</volume><spage>e49828</spage><epage>e49828</epage><pages>e49828-e49828</pages><issn>1929-0748</issn><eissn>1929-0748</eissn><abstract>Background:Individual face-to-face cognitive behavioral therapy is known to be effective for bulimia nervosa (BN). Since foods vary considerably between regions and cultures in which patients live, cultural adaptation of the treatment program is particularly important in cognitive behavioral therapy for BN. Recently, an internet-based cognitive behavioral therapy (ICBT) program was developed for Japanese women with BN, adapted to the Japanese food culture. However, no previous randomized controlled trial has examined the effectiveness of ICBT.Objective:This paper presents a research protocol for strategies to examine the effects of guided ICBT.Methods:This study is designed as a multicenter, prospective, assessor-blinded randomized controlled trial. The treatment groups will be divided into treatment as usual (TAU) alone as the control group and ICBT combined with TAU as the intervention group. The primary outcome is the total of binge eating and purging behaviors assessed before and after treatment by an independent assessor. Secondary outcomes will include measures of eating disorder severity, depression, anxiety, quality of life, treatment satisfaction, and working alliances. Treatment satisfaction and working alliances will be measured post assessment only. Other measures will be assessed at baseline, post intervention, and follow-up, and the outcomes will be analyzed on an intention-to-treat basis.Results:This study will be conducted at 7 different medical institutions in Japan from August 2022 to October 2026. Recruitment of participants began on August 19, 2022, and recruitment is scheduled to continue until July 2024. The first participants were registered on September 8, 2022.Conclusions:This is the first multicenter randomized controlled trial in Japan comparing the effectiveness of ICBT and TAU in patients with BN.Trial Registration:University Hospital Medical Information Network UMIN000048732; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522International Registered Report Identifier (IRRID):DERR1-10.2196/49828</abstract><cop>Toronto</cop><pub>JMIR Publications</pub><pmid>37725414</pmid><doi>10.2196/49828</doi><orcidid>https://orcid.org/0000-0003-2209-352X</orcidid><orcidid>https://orcid.org/0000-0002-5444-0568</orcidid><orcidid>https://orcid.org/0000-0002-0668-6838</orcidid><orcidid>https://orcid.org/0009-0009-0697-8871</orcidid><orcidid>https://orcid.org/0000-0002-0270-797X</orcidid><orcidid>https://orcid.org/0000-0001-7847-6381</orcidid><orcidid>https://orcid.org/0000-0003-4753-6745</orcidid><orcidid>https://orcid.org/0009-0004-8876-0887</orcidid><orcidid>https://orcid.org/0000-0001-7383-9163</orcidid><orcidid>https://orcid.org/0000-0001-5558-0418</orcidid><orcidid>https://orcid.org/0000-0002-3466-3035</orcidid><orcidid>https://orcid.org/0000-0003-2210-5025</orcidid><orcidid>https://orcid.org/0000-0003-2265-0349</orcidid><orcidid>https://orcid.org/0000-0003-0505-6882</orcidid><orcidid>https://orcid.org/0000-0003-3844-3061</orcidid><orcidid>https://orcid.org/0009-0000-2624-6568</orcidid><oa>free_for_read</oa></addata></record> |
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| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_824386 |
| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; SWEPUB Freely available online; PubMed Central Open Access; PubMed Central |
| subjects | Anxiety Behavior modification Binge eating Body image Bulimia Clinical trials Communication Eating disorders Females Hospitals Information technology Informed consent Internet access Intervention Literacy Medicin och hälsovetenskap Mental disorders Mental health Post traumatic stress disorder Protocol Questionnaires Self image Therapists Therapy Women |
| title | Guided Internet-Based Cognitive Behavioral Therapy for Women With Bulimia Nervosa: Protocol for a Multicenter Randomized Controlled Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-16T17%3A32%3A18IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Guided%20Internet-Based%20Cognitive%20Behavioral%20Therapy%20for%20Women%20With%20Bulimia%20Nervosa:%20Protocol%20for%20a%20Multicenter%20Randomized%20Controlled%20Trial&rft.jtitle=JMIR%20research%20protocols&rft.au=Hamatani,%20Sayo&rft.date=2023-01-01&rft.volume=12&rft.spage=e49828&rft.epage=e49828&rft.pages=e49828-e49828&rft.issn=1929-0748&rft.eissn=1929-0748&rft_id=info:doi/10.2196/49828&rft_dat=%3Cproquest_swepu%3E2866759721%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2918523025&rft_id=info:pmid/37725414&rfr_iscdi=true |