Maudsley model of Anorexia Nervosa treatment for Japanese outpatient randomized controlled trial

Maudsley Anorexia Nervosa treatment for adults for Japanese outpatients: a randomized controlled trial - MAJOR study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030210262

Enrollment

Registered

2021-08-19

Start date

2021-09-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa eating disorder, anorexia nervosa, psychotherapy, randomised controlled trial

Interventions

In the intervention group, patients receive a manual-based psychotheray, the Maudsley Model of Anorexia Nervosa. Treatment for Adults (MANTRA), using the Japanese version MANTRA workbook combined wi

psycotherapy, MANTRA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. outpatients meeting the current diagnostic criteria for AN according to DSM-5 criteria 2. age range between 16 and 65 years 3. the body mass index (BMI) is > or =14 and < or=18.5 kg/m2 at baseline 4. those who were able to understand the protocol, who were taken written informed consent, agreed to participate in the trial

Exclusion criteria

Exclusion criteria: 1. severe AN patients with life-threatening starvation requiring immediate in-patients treatment 2. those with physical illness such as diabetes mellitus 3. those with severe mental illness with high likelihood of attempting suicide 4. those with severe mental illness such as current severe substance dependence 5. those with intelligence disability 6. those with insufficient knowledge of Japanese to understand the treatment, 7. women currently pregnant,

Design outcomes

Primary

Measure	Time frame
the change of BMI at baseline and post-treatment (30 weeks)	—

Secondary

Measure	Time frame
1. the changes of BMI between baseline, at 10 weeks, 20 weeks, 2 month follow up 2. the eating disorders features, using the self reported questionnaires such as the EDEQ, the EDI2, at baseline, 10weeks, 20 weeks, post treatment (30 weeks), and 2 month follow up 3. the general psychopathology including the Hospital Anxiety and Depression Scale (HADS), the 5 level EuroQoL5 dimension (EQ5D5L), the psychosocial functioning using the Clinical Global Impression Scale Severity and Change (CGI SC), the Global Assessment of Functioning (GAF), the Clinical Impairment Assessment questionnaire (CIA) at baseline, 10weeks, 20 weeks, post treatment (30 weeks), and 2 month follow up 4. the Motivation Ruler, the credibility and or expectancy questionnaire (CEQ) at baseline, 10weeks, 20 weeks, post treatment (30 weeks), and 2 month follow up 5. drop out rates at post treatment	—

Measure

Time frame

1. the changes of BMI between baseline, at 10 weeks, 20 weeks, 2 month follow up 2. the eating disorders features, using the self reported questionnaires such as the EDEQ, the EDI2, at baseline, 10weeks, 20 weeks, post treatment (30 weeks), and 2 month follow up 3. the general psychopathology including the Hospital Anxiety and Depression Scale (HADS), the 5 level EuroQoL5 dimension (EQ5D5L), the psychosocial functioning using the Clinical Global Impression Scale Severity and Change (CGI SC), the Global Assessment of Functioning (GAF), the Clinical Impairment Assessment questionnaire (CIA) at baseline, 10weeks, 20 weeks, post treatment (30 weeks), and 2 month follow up 4. the Motivation Ruler, the credibility and or expectancy questionnaire (CEQ) at baseline, 10weeks, 20 weeks, post treatment (30 weeks), and 2 month follow up 5. drop out rates at post treatment

—

Contacts

Public ContactMichiko Nakazato

International University of Health and Welfare, Narita Hospital

mnak@iuhw.ac.jp+81-47-635-5600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026