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

JRCT ID: jRCT1030210262

Registered date:19/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anorexia Nervosa
• Date of first enrollment: 14/09/2021
• Target sample size: 62
• Study type: Interventional
• 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 Outcome: the change of BMI at baseline and post-treatment (30 weeks)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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,

Related Information

• Primary Sponsor: Niitsu Tomihisa
• Secondary Sponsor: Nakazato Michiko,Ministry of Health, Labour and Welfare