JRCT ID: jRCT1030210467
Registered date:03/12/2021
Safety and efficacy of cognitive remediation therapy for anorexia nervosa
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Eating disorders presenting as emaciation |
Date of first enrollment | 03/12/2021 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | In CRT, eight sessions are conducted through tasks that are set specifically to improve cognitive function and that are interesting to the patient, and "look back and home work" is conducted so that the patient can become aware of his or her own thinking style, leading to behavioral changes in daily life. Cognitive function improvement therapy (8 sessions + 1 follow-up session) will be conducted while the patient continues to receive regular medical care at the primary care physician (family doctor). Symptom assessment will be conducted at the pre-start, end (8 weeks), and 1-month follow-up. Sessions 1 to 8 As a general rule, the sessions will be conducted in the following order, but may be modified as needed to meet the individual patient's level of understanding and progress. The number of sessions will not be extended. Session 10 (Reflection) will be included in the final session. (Seven of the following sessions (1-9) will be selected for this session, and a "general review" session will be held in the last week. |
Outcome(s)
Primary Outcome | 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). |
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Secondary Outcome | <Secondary Efficacy Endpoints> 1.Change from baseline in ROCFT total score and sub-item (order and style) score at 8 weeks. 2.Change from baseline in the number of Brixton errors at 8 weeks. 3. change from Week 0 (baseline) in WCST subscore other than total errors at 8 weeks 4. change from baseline in Eating Attitudes Test (EAT-26) score at 8 weeks 5. change from baseline in depression score using the Hospital Anxiety and Depression Scale (HADS) at 8 weeks 6. change from week 0 (baseline) in quality of life score at 8 weeks using the Pediatric Quality of Life Inventory (PedsQL) 7. change from week 0 (baseline) in scores on the EQ-5D-5L (Euro-QOL5Dimension) medicoeconomic health-related quality of life assessment scale at 16 weeks 8. Wechsler Adult Intelligence Scale-Forth Edition (WAIS-IV Intelligence Test) 9. Autism Spectrum Quotient (AQ) Safety secondary endpoints BMI at the time of assessment and at week 8, and no significant difference in the amount of change in BMI at week 8 from the time of assessment (baseline). 2) Frequency of adverse events Adverse events will be evaluated in three levels of severity: "mild, moderate, and severe" <Exploratory endpoints> The correlation between the comorbidity of autism spectrum disorder and the treatment effect will be examined. 1. Autism Diagnosis Observation Schedule Second Edition (ADOS-2, semi-structured interview for the assessment of autism spectrum disorder) 2.Questionnaire to be completed by parents 1) Social Responsiveness Scale Second Edition (SRS-2, Interpersonal Responsiveness Scale) 2) Assessment of quality of life (QOL) using the Pediatric Quality of Life Inventory (PedsQL). 3)Child Autism Spectrum Quotient (Child AQ) 4) Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS, Attention Deficit/Hyperactivity Disorder: Rating Scale for Diagnosis, Screening, and Severity Assessment) |
Key inclusion & exclusion criteria
Age minimum | >= 10age old |
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Age maximum | <= 25age 11month 4weeks old |
Gender | Both |
Include criteria | (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-5. 2. BMI between 14.0 and 18.5 kg/m2 at the time of consent. 3. between 10 and 25 years of age at the time of consent. 4. 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. 7. be mentally and physically able to attend eight consecutive CRT sessions on a fixed day and time once a week. |
Exclude criteria | 1. patients with serious physical complications 2. patients who require behavioral restrictions due to low body weight 3. patients with impending thoughts of death 4. 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.) |
Related Information
Primary Sponsor | Shimizu Eiji |
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Secondary Sponsor | Numata Noriko |
Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology |
Secondary ID(s) | Nil known |
Contact
Public contact | |
Name | Noriko Numata |
Address | 1-8-1 Inohana Chuo-ku Chiba city Chiba Japan 260-8670 Chiba Japan 260-8670 |
Telephone | +81-43-226-2027 |
n_numata@chiba-u.jp | |
Affiliation | Chiba University |
Scientific contact | |
Name | Eiji Shimizu |
Address | 1-8-1 Inohana Chuo-ku Chiba city Chiba Japan 260-8670 Chiba Japan 260-8670 |
Telephone | +81-43-226-2027 |
eiji@faculty.chiba-u.jp | |
Affiliation | Chiba University |