Safety and efficacy of cognitive remediation therapy compared with usual treatment for anorexia nervosa: a randomised controlled trial

Cognitive Behavioral Therapy Center, Chiba University Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年12月3日

试验速览

暂无简介。

•(1) Patients who meet the diagnostic criteria for anorexia nervosa (including eating disorders that cause emaciation such as avoidance and restrictive food intake) in DSM-
•BMI between 14.0 and 18.5 kg/m2 at the time of consent.
•between 10 and 25 years of age at the time of consent.
•onset of illness less than 3.5 years
•(5) Patients who have no coexisting serious psychiatric disorders according to the Brief Structured Interview for Mental Illness (M.I.N.I.).
•(6) Patients who have received a written consent form of their own free will and that of their parents or guardians after receiving sufficient explanation and understanding of the study.
•be mentally and physically able to attend eight consecutive CRT sessions on a fixed day and time once a week.

•patients with serious physical complications
•patients who require behavioral restrictions due to low body weight
•patients with impending thoughts of death
•patients who have difficulty in understanding assessment and treatment due to intellectual disability
•5.Patients who have difficulty in understanding assessment and treatment due to poor understanding of Japanese, even considering their age.
•6.Patients who have repeated antisocial behavior or have difficulty communicating with the researcher.
•7.Patients who are judged by the investigator or sub-investigator to be inappropriate for the safe conduct of the study.
•(Patients on stable volume drug therapy will not be excluded.)

Change in the total number of errors

时间窗: week 0 to week 8

Change in the total number of errors at week 0 from the total number of errors at week 8 of the Wisconsin Card Sorting Test (WCST)

Eating Attitudes Test (EAT-26) score(8 weeks)
Hospital Anxiety and Depression Scale (HADS)(8 weeks)
Pediatric Quality of Life Inventory (PedsQL)(8 weeks)
ROCFT total score and sub-item (order and style) score(8 weeks)
Brixton errors(8 weeks)
WCST subscore other than total errors(8 weeks)
EQ-5D-5L (Euro-QOL5Dimension) medicoeconomic health-related quality of life assessment scale(16 weeks)
BMI(8 weeks)
Frequency of adverse events
Autism Diagnosis Observation Schedule Second Edition (ADOS-2)
Social Responsiveness Scale Second Edition (SRS-2)
Assessment of quality of life (QOL) using the Pediatric Quality of Life Inventory (PedsQL)
Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS)

发起方

Cognitive Behavioral Therapy Center, Chiba University Hospital