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Clinical Trials/JPRN-jRCT1030210467
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.

Registry
who.int
Start Date
December 3, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Shimizu Eiji

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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