UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of cognitive rihabilitation (NEAR:Neuropsychological and Educational Approach to cognitive Remediation) and cognitive impairment on Anorexia Nervosa
Title of the study (Brief title)	Cognitive impairment on Anorexia Nervosa
Region	Japan

Condition
Condition	Anorexia Nervosa
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of cognitive impairment on Anorexia Nervosa by BACS(Brief assessment of cognition in Schizophrenia) and effect of cognitive rehabilitation (NEAR:Neuropsychological and Educational Approach to cognitive Remediation)
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The change of BACS(Brief assessment of cognition in Schizophrenia) after cognitive rehabilitation for 6 months
Key secondary outcomes	Self Efficacy for Community Life scale : SECL, Life Assessment Scale for Mental Ill : LASMI, The Global Assessment of Functioning Scale : GAF, Hamilton Depression Rating Scale : HAM-D, Trail Making Test-B : TMT-B, Wisconsin Card Sorting Test : WCST, Rey- Osterrieth Complex Figure Test : RCFT, Eating Attitude Test- 26 : EAT-26

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	cognitive rehabilitation for 6 months, twice a week, 1-1.5 hours a day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	intelligence quotient is over 70 by Wechsler Adult Intelligence Scale - Third Edition : WAIS-3, z score of all low order items are over -2 standard deviation by BACS : Brief Assessment of Cognition in Schizophrenia
Key exclusion criteria	hospitalization comorbidity of schizophrenia, bipolar disorder, and personality disorder
Target sample size	30

Research contact person
Name of lead principal investigator	Naoya Kitamura
Organization	Kawasaki medical college
Division name	Departure of Psychiatry
Address	577 Matsushima, Kurashiki city, Okayama, Japan
TEL	086-462-1111
Email	n-kitamura@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Naoya Kitamura
Organization	Kawasaki medical school
Division name	Departure of Psychiatry
Address	577 Matsushima, Kurashiki city, Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	n-kitamura@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki medical school
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2019 Year 01 Month 17 Day
Date of closure to data entry	2019 Year 01 Month 17 Day
Date trial data considered complete	2019 Year 01 Month 17 Day
Date analysis concluded	2019 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 29 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029319