JPRN-jRCT1030210467
Recruiting
Phase 2
Safety and efficacy of cognitive remediation therapy compared with usual treatment for anorexia nervosa: a randomised controlled trial
Shimizu Eiji0 sites30 target enrollmentDecember 3, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shimizu Eiji
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion 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.)
Outcomes
Primary Outcomes
Not specified
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