UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Group Cognitive Remediation Therapy for Adolescents with Anorexia Nervosa: An evaluation study in a Japanese Sample
Acronym	Effectiveness of Group CRT for Adolescents with AN: An evaluation study in a Japanese Sample
Scientific Title	Effectiveness of Group Cognitive Remediation Therapy for Adolescents with Anorexia Nervosa: An evaluation study in a Japanese Sample
Scientific Title:Acronym	Effectiveness of Group CRT for Adolescents with AN: An evaluation study in a Japanese Sample
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to evaluate effectiveness of CRT group for adolescents with Anorexia Nervosa.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in Motivational ruler (importance to change) between the pre- and post- Group CRT
Key secondary outcomes	Change in each measure(below 1-9)between the pre- and post- CRT 1.Body Mass Index 2.Standard body weight ratio 3.The Rey-Ostterrieth Complex Figure Test(Order of Construction Index, Style Index, Central Coherence Index) 4.Brixton Spatial Anticipation Test(the number of error, score) 5.Children's version of Eating Attitude Test with 26 items 6.Motivational ruler(ability to change) 7.Beck's Depression Inventory-2 8.Rosenberg Self-Esteem Scale 9.Global Assessment of Functioning worksheets Post-CRT Questionnaire1 Post-CRT Questionnaire2(after three months) Dropout rates, reasons

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 CRT(weekly, each session 40 minutes)
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	19 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 19 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 psychosis 4.patients who have history of drug abuse/dependence 5.patients who have active suicidality 6.patients who have critical physical disease 7.patients who have history of participation in a pilot study of group CRT 8.patients assessed by a doctor as unfit for the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Rie Kuge
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Support Center for Children and Family, Department of Psychology and Welfare
Zip code
Address	2-8-29, Musashidai, Fuchu-shi, Tokyo
TEL	0423005111
Email	rie_kuge@tmhp.jp

Public contact
Name of contact person	1st name Middle name Last name Rie Kuge
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Support Center for Children and Family, Department of Psychology and Welfare
Zip code
Address	2-8-29, Musashidai, Fuchu-shi, Tokyo
TEL	0423005111
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 22 Day
Date of IRB	2017 Year 02 Month 22 Day
Anticipated trial start date	2017 Year 04 Month 24 Day
Last follow-up date	2021 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 21 Day
Last modified on	2021 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030281