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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020623
Receipt No. R000023292
Scientific Title Evaluation of a Cognitive Remediation Therapy Group for Adolescents with Anorexia Nervosa:Open study
Date of disclosure of the study information 2016/01/18
Last modified on 2017/04/24

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Basic information
Public title Evaluation of a Cognitive Remediation Therapy Group for Adolescents with Anorexia Nervosa:Open study
Acronym Evaluation of a Cognitive Remediation Therapy Group for Adolescents with Anorexia Nervosa
Scientific Title Evaluation of a Cognitive Remediation Therapy Group for Adolescents with Anorexia Nervosa:Open study
Scientific Title:Acronym 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
1st name
Middle name
Last name Rie Kuge
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Psychology and Welfare
Zip code
Address 2-8-29 Musashidai Fuchu-shi Tokyo
TEL 042-300-5111
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 Division of Psychology and Welfare
Zip code
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)

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
2016 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 11 Month 16 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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