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Eating Disorder Neuroimaging Initiative Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-042685 on 25 January 2021. Downloaded from Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders Sayo Hamatani ,1,2 Yoshiyuki Hirano ,1,3 Ayako Sugawara,4 Masanori Isobe,5 Naoki Kodama,6 Kazufumi Yoshihara,7 Yoshiya Moriguchi,4 Tetsuya Ando,4 Yuka Endo,8 Jumpei Takahashi,1 Nobuhiro Nohara,9 Tsunehiko Takamura,4 Hiroaki Hori,4 Tomomi Noda,2,5 Keima Tose,5 Keita Watanabe,10 Hiroaki Adachi ,6 Motoharu Gondo,7,11 Shu Takakura,7 Shin Fukudo,8,12 Eiji Shimizu,1,13 Kazuhiro Yoshiuchi,9 Yasuhiro Sato,8 Atsushi Sekiguchi4 To cite: Hamatani S, Hirano Y, ABSTRACT Strengths and limitations of this study Sugawara A, et al. Eating Introduction Anorexia nervosa is a refractory psychiatric disorder Disorder Neuroimaging Initiative with a mortality rate of 5.9% and standardised mortality ratio of ► The research project will seek to clarify diagnos- (EDNI): a multicentre prospective 5.35, which is much higher than other psychiatric disorders. The cohort study protocol for tic and therapeutic markers and identify predictive standardised mortality ratio of bulimia nervosa is 1.49; however, elucidating the neural effects of markers of treatment response in patients with eat- it is characterised by suicidality resulting in a shorter time to cognitive–behavioural therapy ing disorders using a longitudinal approach. death. While there is no current validated drug treatment for for eating disorders. BMJ Open ► This should contribute to the early detection and eating disorders in Japan, cognitive–behavioural therapy (CBT) 2021;11:e042685. doi:10.1136/ early intervention of eating disorders. bmjopen-2020-042685 is a well- established and commonly used treatment. CBT is also ► We will also create a brain imaging database in recommended in the Japanese Guidelines for the Treatment of Prepublication history and Japan for those with eating disorders. ► Eating Disorders (2012) and has been covered by insurance since additional material for this paper ► MRI equipment and treatment protocols are not http://bmjopen.bmj.com/ 2018. However, the neural mechanisms responsible for the effect is available online. To view these completely unified. files, please visit the journal of CBT have not been elucidated, and the use of biomarkers such online (http:// dx. doi. org/ 10. as neuroimaging data would be beneficial. 1136/ bmjopen- 2020- 042685). Methods and analysis The Eating Disorder Neuroimaging Initiative is a multisite prospective cohort study. We will and abnormal eating behaviours. They are Received 11 July 2020 longitudinally collect data from 72 patients with eating mainly classified as anorexia nervosa (AN), Revised 09 December 2020 disorders (anorexia nervosa and bulimia nervosa) and 70 Accepted 10 January 2021 bulimia nervosa (BN) and binge- eating controls. Data will be collected at baseline, after 21–41 1 sessions of CBT and 12 months later. We will assess disorder (BED). In Japan, the number longitudinal changes in neural circuit function, clinical of patients with EDs has increased about on September 26, 2021 by guest. Protected copyright. 2 data, gene expression and psychological measures by 10- fold between the 1980s and 1990s. Based therapeutic intervention and analyse the relationship on a meta- analysis including 36 studies, AN among them using machine learning methods. was found to have a standardised mortality Ethics and dissemination The study was approved by ratio (SMR) of 5.13 and the highest mortality The Ethical Committee of the National Center of Neurology rate among mental disorders.4–7 In addition, and Psychiatry (A2019-072). We will obtain written informed renal function decreases as the duration consent from all patients who participate in the study after they of AN increases,8 and patients often suffer © Author(s) (or their had been fully informed about the study protocol. All imaging, from various physical complications asso- demographic and clinical data are shared between the employer(s)) 2021. Re- use ciated with prolonged symptoms and low permitted under CC BY-NC. No participating sites and will be made publicly available in 2024. 9–12 commercial re- use. See rights Trial registration number UMIN000039841 weight. The rate of chronicity for patients and permissions. Published by with AN for up to 10 years is approximately BMJ. 10%–20%, and the long- term prognosis For numbered affiliations see is poor.13 14 Furthermore, current treat- end of article. ments may not be effective in severe cases 15 Correspondence to INTRODUCTION of chronic AN. Regarding BN, the SMR is Dr Atsushi Sekiguchi; Eating disorders (EDs) are a psychiatric 1.49; however, it is characterised by suicid- asekiguchi@ ncnp. go. jp disorder with a focus on body shape, weight ality resulting in a shorter time to death.3 Hamatani S, et al. BMJ Open 2021;11:e042685. doi:10.1136/bmjopen-2020-042685 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-042685 on 25 January 2021. Downloaded from Therefore, early detection and early intervention are and mainly takes place in Germany. For the time being, important. they have used methods to meta- analyse anatomical Cognitive–behavioural therapy (CBT) is a psycho- images and diffusion tensor-weighted images of patients therapy that aims to improve psychiatric symptoms by with AN and BN that have already been imaged at partic- focusing on cognitive processes and behavioural patterns. ipating facilities. The ENIGMA-Eating Disorders study CBT for EDs identifies the psychopathology that contrib- is expected to build a framework for joint research to utes to the disease while advancing regular eating and be developed in the future. However, ED brain image weight- regulating behavioural modifications.16 Cognitive multicentre research has not been found to have been styles such as fear of weight gain and adherence to body conducted, even when searching the world’s major clin- shape and behavioural patterns such as dietary restric- ical research registration sites such as ClinicalT rials. gov in tions and excessive exercise are often seen in EDs17; CBT the USA and EU register in the EU. Furthermore, an ED can be used to address these psychopathologies.16 CBT brain image database has not yet been developed globally. has been shown to be effective as a psychotherapy for EDs,18–20 and CBT is also recommended in the National Aims and hypotheses Institute for Health and Care Excellence (NICE) guide- We aim to generate neuroscientific evidence for the lines.21 Meta- analyses of Randomised Controlled Trials effect of CBT. First, we will longitudinally collect brain (RCTs) that include waitlist controls report that CBT is MRI images and clinical data in observational studies particularly effective for BN and BED.22–26 In Japan, there before and after CBT for EDs. Next, we will identify are two reports on the effectiveness and feasibility of CBT clinical biomarkers of EDs through analytical studies for BN or BED,27 28 and the national health insurance has using longitudinal image data before and after CBT for covered CBT in Japan since 2018. However, according EDs and create neural evidence for the effect of CBT. to a meta- analysis of RCTs, the dropout rate for CBT is We aim to identify brain image biomarkers that can be approximately 24%,29 and there are large individual used as clinical markers (diagnostic markers, therapeutic differences in treatment responsiveness. markers and therapeutic response prediction markers) To the best of our knowledge, there are no reports of for EDs. We hypothesise the following: (1) characteristic neural mechanisms that regulate the effects and treat- brain circuit abnormalities exist for each type of ED; ment responses of CBT for EDs. Therefore, accumulating (2) there are brain circuit changes that correlate with evidence using brain imaging and biomarkers of gene changes in severity before and after treatment for ED; expression would further our understanding of CBT and (3) there are brain circuit features that define the effectiveness for EDs. The identification of biomarkers therapeutic response of CBT for ED. Furthermore, the may provide clues to the development of diagnostic and brain image data collected for this project will be inte- therapeutic methods based on the elucidation of the grated into an international brain database prepared by pathophysiology and pathogenic mechanism of EDs. It the Japan Agency for Medical Research and Development http://bmjopen.bmj.com/ may contribute to social implementation of early detec- (AMED). In the future, after the AMED Brain/MINDS tion and early intervention with diagnostic methods using Beyond human brain MRI database is constructed, it will objective indicators. be possible to access the database. At the moment, the Since individuals with EDs show abnormal eating portal site (https:// brainminds- beyond. jp/ ja/ resources/ behaviours, structural and functional brain imaging 2020/ 05/ amedmri. html) is being created (Details of The studies have been conducted to elucidate the neural basis Brain / MINDS Beyond human brain MRI project: Koike of these abnormalities through brain imaging research. et al, 2020 preprint). There are various reports on brain imaging research in on September 26, 2021 by guest. Protected copyright. patients with ED that have revealed abnormal reward systems,30 reductions in grey matter of various brain METHODS AND ANALYSIS
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