UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000010382 |
|---|---|
| Receipt number | R000009582 |
| Scientific Title | Feasibility study of Cognitive Behavioural Therapy for At-Risk Mental State in Japan: an open-label pilot study |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2017/11/09 17:42:39 |
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Basic information
Public title
Feasibility study of Cognitive Behavioural Therapy for At-Risk Mental State in Japan: an open-label pilot study
Acronym
CBT-ARMS-J
Scientific Title
Feasibility study of Cognitive Behavioural Therapy for At-Risk Mental State in Japan: an open-label pilot study
Scientific Title:Acronym
CBT-ARMS-J
Region
| Japan |
Condition
Condition
At-Risk Mental State
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test feasibility of Cognitive Behavioral Therapy for At-Risk Mental State in Japanese clinical settings
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Togal Score of PANSS(Positive and Negative Syndrome Scale)
Key secondary outcomes
Positive Scale, Negative Scale, and General Psychopathology scale of PANSS(Positive and Negative Syndrome Scale)
Postive Symptom Scales of CAARMS (unusual thought content, non-bizarre ideas, perceptural abnormalities, disorganised speech)
BDI-II(Beck Depression Inventory)
BCIS(Beck Cognitive Insight Scale)
BCSS(Brief Core Schema Scale)
GAF(The Global Assessment of Functioning)
SOFAS(Social and Occupational Functioning Assessment Scale)
STAI(State Trait Anxiety Inventory)
WHO-QOL26
Suicidality and self harm on CAARMS
Aggression/Dangerous Behaviour on CAARMS
CGIC(Clinical Global Impression of Change)
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
| Behavior,custom |
Interventions/Control_1
Cognitive Behavioral Therapy for At-Risk Mental State
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
| 14 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A)
Key exclusion criteria
A)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Matsumoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7262
kaz-mat@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Katsura |
Organization
Tohoku University Hospital
Division name
Department of Psychiatry
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7262
Homepage URL
katsura-thk@umin.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Ministry of Health and Labor
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Department of Psychiatry, Tohoku University Hospital
Department of Psychiatry, Tohoku University Graduate School of Medicine
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
東北大学病院
(Tohoku University Hospital)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2017 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009582
| 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 |
