Effectiveness of enhanced cognitive behavior therapy for bulimia nervosa in Japan: a randomized controlled trial protocol

Abstract

Background: The effectiveness of psychotherapeutic interventions for eating disorders (EDs) is widely studied in Europe, North America, and Australia/New Zealand. However, few controlled studies and no randomized controlled trials (RCTs) have been conducted in Japan despite the relatively high prevalence of EDs in the Japanese population. The aim of this study is to evaluate the effect of enhanced cognitive behavior therapy (CBT-E), an evidence-supported ED-focused form of cognitive behavior therapy (CBT), for the treatment of bulimia nervosa (BN) in Japan. Methods/design: This multicenter RCT will compare CBT-E with treatment as usual (TAU), which is widely used in Japan. A group of 140 adult outpatients with a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnosis of BN, ≥18 years of age, a body mass index (BMI) > 17.5 and < 40 kg/m 2 will be randomly assigned to CBT-E or TAU. Participants will be stratified by intervention site and BN severity. CBT-E participants will receive 20 sessions of focused form CBT-E for 20 weeks. Those in the TAU group will receive routine treatment provided by specialists. Assessment will be performed in a blinded manner prior to the start of treatment, after 6 weeks of treatment, at the end of treatment (20 weeks), and at follow-up at 40 and 80 weeks after the start of treatment. The primary outcome is the remission of BN, defined by the absence, in the previous 4 weeks, of symptoms required to meet the DSM-5 criteria for a diagnosis of BN. Secondary outcomes include the levels of ED psychopathology and impairment due to the ED, anxiety, depression, family function, and satisfaction with treatment. Discussion: This will be the first RCT conducted in Japan to compare CBT-E and TAU for the treatment of BN. If CBT-E is found to be more effective than TAU, then the evidence would support its wider use for patients with BN in Japan. Because it is possible to train therapists who do not possess extensive specialist experience, wider use is also likely to be practically feasible. In addition, demonstrating the effectiveness of CBT-E in Japan would demonstrate that it could be successfully extended to additional world cultures and regions.

DNASE1L3 enhances antitumor immunity and suppresses tumor progression in colon cancer

“…The intratumoral levels of total cDCs and XCR1 + cDC1 were comparable between Dnase1l3 -KO and WT mice ( Supplemental Figure 8 , B and C). However, relatively few XCR1 + cDC1 in dLNs of KO mice expressed the immune activation marker PD-L1 ( 28 ), compared with their counterparts in WT mice ( Figure 5J ). These data suggest that the enhanced tumor growth in Dnase1l3 -deficient mice might be a result of impaired DC function and consequent reduction in cytotoxic CD8 + and CD4 + T cells in dLNs and tumors.…”

The effectiveness and cultural adaptations of psychological interventions for eating disorders in East Asia: A systematic scoping review

“…This may be due to the fact that these interventions were introduced into ED guidelines and into clinical settings only relatively recently—for example, FBT was introduced in 2015 in a local hospital in Japan (Iguchi et al, 2021), and DBT was introduced to China in 2017 (Chen et al, 2021). Ohara et al (2020) also mentioned that CBT‐E was rarely available in Japan.…”

“…In terms of service provision, evidence‐based psychological interventions such as cognitive behavioral therapy (CBT) (Fairburn, 2008), dialectical behavioral therapy (DBT) (Linehan, 2014), and family‐based treatment (FBT) (Lock & Le Grange, 2015) were introduced fairly recently to China (Chen et al, 2021). In Japan, enhanced CBT (CBT‐E) is rarely available (Ohara et al, 2020). The demand for services is high and typically can only afford limited and infrequent contact time, where each session might only last from 5 to 30 min (Iguchi et al, 2021).…”

“…4 | DISCUSSION The present systematic scoping review examined the quantity and types of ED-focused psychological interventions and their cultural adaptations and effectiveness in East Asia to address the gaps in ED treatment research in non-Western settings.4.1 | Dominance of cognitive and cognitive behavioral approachesThe included interventions were largely cognitive-based, including CBT, cognitive-behavioral GSH, CRT and meta-cognitive training.However, when examining forthcoming/ongoing trials, there is a greater variety of interventions being evaluated, such as FBT, DBT and MANTRA. This may be due to the fact that these interventions were introduced into ED guidelines and into clinical settings only relatively recently-for example, FBT was introduced in 2015 in a local hospital in Japan(Iguchi et al, 2021), and DBT was introduced to China in 2017(Chen et al, 2021) Ohara et al (2020). also mentioned that CBT-E was rarely available in Japan.An interesting observation was that some included (and forthcoming) studies included 13-14 year olds, and offered GSH or CBT tothem, whereas Western countries, such as the UK would offer familybased interventions as the first-line for that age group (National Institute for Health and Care Excellence (NICE), 2020).…”

Eating Disorder Neuroimaging Initiative (EDNI): a multicentre prospective cohort study protocol for elucidating the neural effects of cognitive–behavioural therapy for eating disorders

“…Non-specific psychological indicators (see details as a online supplemental file 1 ): the Mini-International Neuropsychiatric Interview 43 44 for comorbidities; Japanese Adult Reading Test 45 46 for intellectual ability; Beck Depression Inventory-Second Edition 47 48 for severity of depressive symptoms; State-Trait Anxiety Inventory 49 50 for anxiety; NEO Five‐Factor Inventory (NEO‐FFI) 51 52 for personality scores; 20-Item Toronto Alexithymia Scale 53 54 for alexithymia; adult version facial expression recognition test 55 for adult facial expression recognition ability; Edinburgh handedness inventory 56 57 for determining objectively whether one is left or right handed; Childhood Trauma Questionnaire 58 59 for childhood trauma; Post-traumatic Diagnostic Scale 60 61 for trauma; Visual Analogue Scale 62 for expectation to treatment; General Functioning scale of Family Assessment Device 63 64 for family assessment; help-seeking preferences 65 for attitude to seek help for others; Multidimensional Assessment of Interoceptive Awareness 66 67 for relevant dimensions of bodily awareness; Barratt Impulsiveness Scale 68 69 for impulsivity scale; Maudsley Obsessional Compulsive Inventory 70 71 for obsessive–compulsive symptoms scale; Autism-Spectrum Quotient 72 73 for autism tendencies; Rosenberg Self-Esteem Scale (SES) 74 75 for global self-esteem ; Tri-axial Coping Scale 76 for evaluation of stress coping strategies; Working Alliance Inventory 77 for aspects of the therapeutic alliance; EuroQol-5 Dimension 78 79 for quality of life; the Generalized Anxiety Disorder Assessment 80 81 for severity of anxiety; Patient Health Questionnaire 81 82 for depression module; the WHO - Five Well-Being Index 83 for mental health scale; socioeconomic status for education history; and Stanford Sleepiness Scale 84 for subjective sleepiness levels.…”