Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders
Introduction Anorexia nervosa is a refractory psychiatric disorder with a mortality rate of 5.9% and standardised mortality ratio of 5.35, which is much higher than other psychiatric disorders. The standardised mortality ratio of bulimia nervosa is 1.49; however, it is characterised by suicidality r...
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2021-01-01
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| author | Kazuhiro Yoshiuchi Sayo Hamatani Yoshiyuki Hirano Ayako Sugawara Masanori Isobe Naoki Kodama Kazufumi Yoshihara Yoshiya Moriguchi Tetsuya Ando Yuka Endo Jumpei Takahashi Nobuhiro Nohara Tsunehiko Takamura Hiroaki Hori Tomomi Noda Keima Tose Keita Watanabe Hiroaki Adachi Motoharu Gondo Shu Takakura Shin Fukudo Eiji Shimizu Yasuhiro Sato Atsushi Sekiguchi |
| author_facet | Kazuhiro Yoshiuchi Sayo Hamatani Yoshiyuki Hirano Ayako Sugawara Masanori Isobe Naoki Kodama Kazufumi Yoshihara Yoshiya Moriguchi Tetsuya Ando Yuka Endo Jumpei Takahashi Nobuhiro Nohara Tsunehiko Takamura Hiroaki Hori Tomomi Noda Keima Tose Keita Watanabe Hiroaki Adachi Motoharu Gondo Shu Takakura Shin Fukudo Eiji Shimizu Yasuhiro Sato Atsushi Sekiguchi |
| author_sort | Kazuhiro Yoshiuchi |
| collection | DOAJ |
| description | Introduction Anorexia nervosa is a refractory psychiatric disorder with a mortality rate of 5.9% and standardised mortality ratio of 5.35, which is much higher than other psychiatric disorders. The standardised mortality ratio of bulimia nervosa is 1.49; however, it is characterised by suicidality resulting in a shorter time to death. While there is no current validated drug treatment for eating disorders in Japan, cognitive–behavioural therapy (CBT) is a well-established and commonly used treatment. CBT is also recommended in the Japanese Guidelines for the Treatment of Eating Disorders (2012) and has been covered by insurance since 2018. However, the neural mechanisms responsible for the effect of CBT have not been elucidated, and the use of biomarkers such as neuroimaging data would be beneficial.Methods and analysis The Eating Disorder Neuroimaging Initiative is a multisite prospective cohort study. We will longitudinally collect data from 72 patients with eating disorders (anorexia nervosa and bulimia nervosa) and 70 controls. Data will be collected at baseline, after 21–41 sessions of CBT and 12 months later. We will assess longitudinal changes in neural circuit function, clinical data, gene expression and psychological measures by therapeutic intervention and analyse the relationship among them using machine learning methods.Ethics and dissemination The study was approved by The Ethical Committee of the National Center of Neurology and Psychiatry (A2019-072). We will obtain written informed consent from all patients who participate in the study after they had been fully informed about the study protocol. All imaging, demographic and clinical data are shared between the participating sites and will be made publicly available in 2024.Trial registration number UMIN000039841 |
| format | Article |
| id | doaj-art-cd788a49012c457a872a19550b706d87 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-01-01 |
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| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-cd788a49012c457a872a19550b706d872024-11-18T13:00:08ZengBMJ Publishing GroupBMJ Open2044-60552021-01-0111110.1136/bmjopen-2020-042685Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disordersKazuhiro Yoshiuchi0Sayo Hamatani1Yoshiyuki Hirano2Ayako Sugawara3Masanori Isobe4Naoki Kodama5Kazufumi Yoshihara6Yoshiya Moriguchi7Tetsuya Ando8Yuka Endo9Jumpei Takahashi10Nobuhiro Nohara11Tsunehiko Takamura12Hiroaki Hori13Tomomi Noda14Keima Tose15Keita Watanabe16Hiroaki Adachi17Motoharu Gondo18Shu Takakura19Shin Fukudo20Eiji Shimizu21Yasuhiro Sato22Atsushi Sekiguchi23Department of Stress Sciences and Psychosomatic Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, JapanResearch Center for Child Mental Development, Chiba University, Chiba, JapanResearch Center for Child Mental Development, Chiba University, Chiba, JapanDepartment of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan3 Department of Psychiatry, Kyoto University Graduate School of Medicine, Kyoto, JapanDivision of Psychosomatic Medicine, Department of Neurology, University of Occupational and Environmental Health, Kitakyushu, JapanDepartment of Psychosomatic Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanDepartment of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, JapanDepartment of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, JapanDepartment of Psychosomatic Medicine, Tohoku University Hospital, Sendai, JapanResearch Center for Child Mental Development, Chiba University, Chiba, JapanDepartment of Stress Sciences and Psychosomatic Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, JapanDepartment of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, JapanDepartment of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, JapanJapan Society for the Promotion of Science, Tokyo, JapanDepartment of Psychiatry, Graduate School of Medicine, Kyoto University, Kyoto, JapanDepartment of Radiology, University of Occupational and Environmental Health School of Medicine, Kitakyushu, JapanDivision of Psychosomatic Medicine, Department of Neurology, University of Occupational and Environmental Health, Kitakyushu, JapanDepartment of Psychosomatic Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanDepartment of Psychosomatic Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanDepartment of Psychosomatic Medicine, Tohoku University Hospital, Sendai, JapanResearch Center for Child Mental Development, Chiba University, Chiba, JapanDepartment of Pediatrics, Teikyo University School of Medicine Graduate School of Medicine, Itabashi-ku, JapanDepartment of Behavioral Medicine, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, JapanIntroduction Anorexia nervosa is a refractory psychiatric disorder with a mortality rate of 5.9% and standardised mortality ratio of 5.35, which is much higher than other psychiatric disorders. The standardised mortality ratio of bulimia nervosa is 1.49; however, it is characterised by suicidality resulting in a shorter time to death. While there is no current validated drug treatment for eating disorders in Japan, cognitive–behavioural therapy (CBT) is a well-established and commonly used treatment. CBT is also recommended in the Japanese Guidelines for the Treatment of Eating Disorders (2012) and has been covered by insurance since 2018. However, the neural mechanisms responsible for the effect of CBT have not been elucidated, and the use of biomarkers such as neuroimaging data would be beneficial.Methods and analysis The Eating Disorder Neuroimaging Initiative is a multisite prospective cohort study. We will longitudinally collect data from 72 patients with eating disorders (anorexia nervosa and bulimia nervosa) and 70 controls. Data will be collected at baseline, after 21–41 sessions of CBT and 12 months later. We will assess longitudinal changes in neural circuit function, clinical data, gene expression and psychological measures by therapeutic intervention and analyse the relationship among them using machine learning methods.Ethics and dissemination The study was approved by The Ethical Committee of the National Center of Neurology and Psychiatry (A2019-072). We will obtain written informed consent from all patients who participate in the study after they had been fully informed about the study protocol. All imaging, demographic and clinical data are shared between the participating sites and will be made publicly available in 2024.Trial registration number UMIN000039841https://bmjopen.bmj.com/content/11/1/e042685.full |
| spellingShingle | Kazuhiro Yoshiuchi Sayo Hamatani Yoshiyuki Hirano Ayako Sugawara Masanori Isobe Naoki Kodama Kazufumi Yoshihara Yoshiya Moriguchi Tetsuya Ando Yuka Endo Jumpei Takahashi Nobuhiro Nohara Tsunehiko Takamura Hiroaki Hori Tomomi Noda Keima Tose Keita Watanabe Hiroaki Adachi Motoharu Gondo Shu Takakura Shin Fukudo Eiji Shimizu Yasuhiro Sato Atsushi Sekiguchi Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders BMJ Open |
| title | Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders |
| title_full | Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders |
| title_fullStr | Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders |
| title_full_unstemmed | Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders |
| title_short | Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders |
| title_sort | eating disorder neuroimaging initiative edni a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive behavioural therapy for eating disorders |
| url | https://bmjopen.bmj.com/content/11/1/e042685.full |
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