UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025474 |
|---|---|
| Receipt number | R000029319 |
| Scientific Title | The effect of cognitive rihabilitation (NEAR:Neuropsychological and Educational Approach to cognitive Remediation) and cognitive impairment on Anorexia Nervosa |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/01/17 19:37:12 |
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Basic information
Public title
The effect of cognitive rihabilitation (NEAR:Neuropsychological and Educational Approach to cognitive Remediation) and cognitive impairment on Anorexia Nervosa
Acronym
Cognitive impairment on Anorexia Nervosa
Scientific Title
The effect of cognitive rihabilitation (NEAR:Neuropsychological and Educational Approach to cognitive Remediation) and cognitive impairment on Anorexia Nervosa
Scientific Title:Acronym
Cognitive impairment on Anorexia Nervosa
Region
| Japan |
Condition
Condition
Anorexia Nervosa
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of cognitive impairment on Anorexia Nervosa by BACS(Brief assessment of cognition in Schizophrenia) and effect of cognitive rehabilitation (NEAR:Neuropsychological and Educational Approach to cognitive Remediation)
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of BACS(Brief assessment of cognition in Schizophrenia) after cognitive rehabilitation for 6 months
Key secondary outcomes
Self Efficacy for Community Life scale : SECL, Life Assessment Scale for Mental Ill : LASMI, The Global Assessment of Functioning Scale : GAF, Hamilton Depression Rating Scale : HAM-D, Trail Making Test-B : TMT-B, Wisconsin Card Sorting Test : WCST, Rey- Osterrieth Complex Figure Test : RCFT, Eating Attitude Test- 26 : EAT-26
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
cognitive rehabilitation
for 6 months, twice a week, 1-1.5 hours a day
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
intelligence quotient is over 70 by Wechsler Adult Intelligence Scale - Third Edition : WAIS-3, z score of all low order items are over -2 standard deviation by BACS : Brief Assessment of Cognition in Schizophrenia
Key exclusion criteria
hospitalization
comorbidity of schizophrenia, bipolar disorder, and personality disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Kitamura |
Organization
Kawasaki medical college
Division name
Departure of Psychiatry
Zip code
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
n-kitamura@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Kitamura |
Organization
Kawasaki medical school
Division name
Departure of Psychiatry
Zip code
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
Homepage URL
n-kitamura@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 17 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 17 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 29 | Day |
Last modified on
| 2019 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
