NIPH Clinical Trials Search

Maintenance Effects of the Maudsley Model for Anorexia Nervosa: A Randomized Controlled Trial Investigating Neural Mechanisms

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Anorexia Nervosa
Date of first enrollment	25/03/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	In this study, the intervention using MANTRA will be conducted by therapists who have previously attended the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) therapist training workshop, using the Maudsley Anorexia Nervosa Treatment MANTRA Workbook. Before starting treatment, therapists are required to complete the MANTRA therapist training workshop and participate in group supervision approximately once every two weeks to ensure treatment fidelity. Participants will receive the Japanese version of the MANTRA workbook prior to the start of therapy and will work collaboratively with the therapist following the program. For underage patients, at least four family sessions will be conducted in parallel. Sessions will be conducted face-to-face in an individual psychotherapy format. Family sessions will be conducted face-to-face with both the patient and family members present, or with family members only. Cognitive Remediation Therapy (CRT) was originally developed to improve cognitive functioning in schizophrenia and was adapted for anorexia nervosa by Dr. Kate Tchanturia at the University of London in 2005. CRT consists of ten tasks specifically designed to enhance cognitive flexibility (set-shifting) and central coherence. Through these tasks, patients become aware of their thinking styles (e.g., rigidity, difficulty in shifting perspectives), carry out behavioral homework in daily life, and aim to apply these cognitive changes in real-life situations. Engaging in these behavioral tasks is expected to reduce anxiety and provide a sense of accomplishment associated with positive change. CRT sessions will be conducted in a group therapy, face-to-face format. Additionally, former patients with anorexia nervosa who have previously received MANTRA will participate as CRT peer supporters in one review session. Peer supporters will be informed in advance about their role as CRT supporters, and their consent will be obtained prior to participation. Treatment will consist of weekly MANTRA sessions up to Week 26. In the MANTRA + CRT group, after completing the 26 MANTRA sessions, participants will receive an additional 6 weeks (8 sessions) of CRT. In the MANTRA-only group, participants will continue standard clinical care after completing the 26 MANTRA sessions.

Outcome(s)

Primary Outcome

Change in body mass index (BMI, kg/m2) between Week 26 and Week 52

Secondary Outcome

Secondary Outcome Measures 1) Symptom assessment scales using self-administered questionnaires <Before trearment, 26w, 32w, 52w) 1. Change in Eating Disorder Examination Questionnaire (EDE-Q) score 2. Change in Eating Disorder Quality of Life (ED-QOL) score 3. Change in Hospital Anxiety and Depression Scale (HADS) score 4. Change in EuroQol 5 Dimensions (EQ-5D) score 5. Change in Clinical Impairment Assessment-Japanese version (CIA-J) score 6. Change in Motivation Assessment Scale score 7. Change in Credibility/Expectancy Questionnaire-II (CEQ-II) score (treatment satisfaction) 8. Change in Cognitive Flexibility Inventory-Japanese version (CFI-J) score 9. Change in Obsessive-Compulsive Inventory-Revised (OCI-R) score 10. Change in Work and Social Adjustment Scale (WSAS) score 2) Screening tests for neurodevelopmental disorders and intellectual functioning <Before treatment> 1. Autism Spectrum Quotient (AQ) 2. Adult ADHD Self-Report Scale (ASRS) 3. Japanese Adult Reading Test (JART) 3) Symptom assessment by structured clinical interview <Before treatment, 26w, 32w, 52w> 1. Change in Clinical Global Impression-Severity/Change (CGI-S/C) score 2. Change in Modified Global Assessment of Functioning Scale-Short Form (mGAF-SF) score 4) Change in cognitive function test scores (ROCFT, CANTAB) <0w, 32w> 5) Dropout rate <32w, 52w> 6) Remission rate <32w, 52w> 7) Brain imaging assessments (resting-state functional MRI, structural MRI,T1-weighted, T2-weighted, DTI) <0w, 26w>

Key inclusion & exclusion criteria

Age minimum	>= 16age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Eligible patients must meet all of the following criteria: 1) Outpatients diagnosed with anorexia nervosa (AN) based on the diagnostic criteria of the DSM-5-TR. 2) Male or female patients aged between 16 and 65 years at the time of obtaining consent. 3) Patients with a BMI between 14.0 kg/m2 and 18.5 kg/m2 (inclusive). 4) Patients who have received sufficient explanation regarding the study, fully understood the content, and have voluntarily provided written informed consent to participate. (For patients aged 17 years or younger, both the patient and their legal representative must provide consent.) 5) Patients who are able to attend outpatient visits once per week.
Exclude criteria	Patients who meet any of the following criteria will be excluded: 1) Patients with serious physical complications or those requiring hospitalization for the treatment of physical symptoms. 2) Patients who require treatment for serious physical illnesses (e.g., diabetes). 3) Patients with imminent suicidal ideation or severe psychiatric symptoms. 4) Patients with comorbid substance dependence or alcohol dependence. 5) Patients with intellectual disability or learning disorders that make it difficult to understand the assessments and treatment procedures. 6) Patients with insufficient understanding of the Japanese language, making it difficult to comprehend the assessments and treatment procedures. 7) Pregnant patients. 8) Any other patients deemed inappropriate for safe participation in this study by the principal investigator or sub-investigator.