UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of a Cognitive Remediation Therapy Group for Adolescents with Anorexia Nervosa:Open study
Title of the study (Brief title)	Evaluation of a Cognitive Remediation Therapy Group for Adolescents with Anorexia Nervosa
Region	Japan

Condition
Condition	anorexia nervosa(AN)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study feasibility of group CRT adolescents with AN and adequacy of CRT session manual
Basic objectives2	Others
Basic objectives -Others	To explore measures for evaluating effectiveness of Group CRT for adolescents with AN
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Rey-Ostterrieth Complex Figure Test will be measured pre and post Group CRT.
Key secondary outcomes	BMI ideal body weight Brixton Test Motivational ruler BDI RSES GAF CGI Dropout rates/reasons Questionnaire (pre-CRT) Worksheet (post-each session) Satisfaction Questionnaire (post-final session)

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	4 sessions of Group Cognitive Remediation Therapy
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	13 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1)patients in whom anorexia nervosa was diagnosed by a child psychiatrist at Department of Child and Adolescent Psychiatry at Tokyo Metropolitan Children's Medical Center using DSM-5 2)hospitalized patients 3)patients between age 13 and 18 years old 4)patients consenting to participation in this study
Key exclusion criteria	1)patients with an intelligence Quotient of less than, or equal to 70 2)patients who have history of brain injury 3)patients who have history of drug abuse/dependence 4)patients who have active suicidality 5)patients who have critical physical disease 6)patients assessed by a doctor as unfit for the study
Target sample size	5

Research contact person
Name of lead principal investigator	Rie Kuge
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of Psychology and Welfare
Address	2-8-29 Musashidai Fuchu-shi Tokyo
TEL	042-300-5111
Email	rie_kuge@tmhp.jp

Public contact
Name of contact person	Rie Kuge
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of Psychology and Welfare
Address	2-8-29 Musashidai Fuchu-shi Tokyo
TEL	042-300-5111
Homepage URL
Email	rie_kuge@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Children's Medical Center
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	東京都立小児総合医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 18 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023292