Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062082) titled 'A Study of the Efficacy of Supportive Psychotherapy for Eating Disorders' on July 30.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Mental Clinic of Dr. Nagata in Nanba
Condition:
Condition - eating disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluation of the efficacy of supportive psychotherapy for eating disorders
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 12-Session Supportive Psychotherapy (Based on the manual developed by the Supportive Psychotherapy Working Group of the Japanese Society for Eating Disorders)
Eligibility:
Age-lower limit - 15
years-old
Gender - Male and Female
Key inclusion criteria - Persons diagnosed with anorexia nervosa based on DSM-5 criteria.
Body mass index (BMI) is greater than 14.0 at starting.
Duration of illness less than 4 years
Outpatients only
Persons who can understand the purpose and content of this trial and give voluntary written informed consent.
For participants who are minors, voluntary written informed consent must be obtained from their parent(s) or legal guardian(s).
Key exclusion criteria - Physical Crisis: (1) Body mass index (BMI) < 14 (2) Little or no food intake for more than 10 consecutive days (3) Rapid weight loss of more than 5 kg within one month (4) Severe electrolyte abnormalities
Psychological Crisis: (1) severe suicidal ideation; (2) self-injurious behavior; (3) violence toward others
Presence of clinically significant psychiatric comorbidities, including severe major depressive disorder, obsessive-compulsive disorder, and borderline (emotionally unstable) personality disorder.
Any patient considered unsuitable for study participation by the principal investigator at the participating study site.
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 13 Day
Date of IRB - 2026 Year 06 Month 13 Day
Anticipated trial start date - 2026 Year 06 Month 25 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071012
Disclaimer: Curated by HT Syndication.