UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026629 |
|---|---|
| Receipt number | 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 | 2021/07/08 14:06:08 |
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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
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
rie_kuge@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030281
