UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026629
Receipt No. R000030281
Scientific Title Effectiveness of Group Cognitive Remediation Therapy for Adolescents with Anorexia Nervosa: An evaluation study in a Japanese Sample
Date of disclosure of the study information 2017/04/24
Last modified on 2019/12/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open public recruiting
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
2020 Year 03 Month 31 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
2019 Year 12 Month 03 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.