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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034204
Receipt No. R000038995
Scientific Title Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa: A Feasibility Study
Date of disclosure of the study information 2018/09/20
Last modified on 2018/09/28

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Basic information
Public title Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa: A Feasibility Study
Acronym Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa
Scientific Title Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa: A Feasibility Study
Scientific Title:Acronym Family Cognitive Remediation Therapy for Children and Adolescents with Anorexia Nervosa
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 feasibility of Cognitive Remediation Therapy for children and adolescents with Anorexia Nervosa.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dropout rates
Key secondary outcomes Change in each measure(below 1-12)between the pre- and post- CRT
1.Body Mass Index
2.Standard body weight ratio
3.Blood test(leptin and ghrelin)
4.The Rey-Ostterrieth Complex Figure Test Order of Construction Index
5.The Rey-Ostterrieth Complex Figure Test Style Index
6.The Rey-Ostterrieth Complex Figure Test Central Coherence Index
7.The Brixton Spatial Anticipation Test the number of error
8.The Brixton Spatial Anticipation Test score
9.Children's version of Eating Attitude Test with 26 items/The Eating Attitude Test with 26 items
10.Motivational ruler
11.The Children's Depression Inventory/Beck's Depression Inventory-2
12.Rosenberg Self-Esteem Scale
13.Worksheets
14.Post-CRT Questionnaire(Children and adolescents)
15.Post-CRT Questionnaire(Family)
16.Dropout 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 Cognitive Remediation Therapy(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
10 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 psychiatrist at Shinshu University Hospital using DSM-5
2.outpatients or hospitalized patients
3.patients between age 10 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 assessed by a doctor as unfit for the study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rie Kuge
Organization Shinshu University Hospital
Division name Mental Health Clinic for Children
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-3060
Email rkuge@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rie Kuge
Organization Shinshu University Hospital
Division name Mental Health Clinic for Children
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-3060
Homepage URL
Email rkuge@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital
Institute
Department

Funding Source
Organization Shinshu University Hospital
Shinshu Public Utility Foundation for Promotion of Medical Science
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 信州大学医学部附属病院(長野県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 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
2018 Year 09 Month 19 Day
Last modified on
2018 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038995

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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