NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1030210262

Registered date:19/08/2021

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedAnorexia Nervosa
Date of first enrollment19/08/2021
Target sample size62
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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 with the treatment as usual (TAU). In the intervention group, patients receive 30 once-weekly individual sessions of therapy and 2 monthly follow up sessions. In the control group, patients receive outpatient treatment as usual, such as psychoeducation, nutritional treatment.

Outcome(s)

Primary Outcomethe change of BMI at baseline and post-treatment (30 weeks)
Secondary Outcome1. 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

Key inclusion & exclusion criteria

Age minimum>= 16age old
Age maximum<= 65age old
GenderBoth
Include criteria1. 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
Exclude criteria1. 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,

Related Information

Contact

Public contact
Name Michiko Nakazato
Address 852 Hatakeda, Narita, Chiba 286-8520, Japan Chiba Japan 286-8520
Telephone +81-47-635-5600
E-mail mnak@iuhw.ac.jp
Affiliation International University of Health and Welfare, Narita Hospital
Scientific contact
Name Masaomi Iyo
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba 260-8677, Japan Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail iyom@faculty.chiba-u.jp
Affiliation Chiba University Hospital