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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010382
Receipt No. 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

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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
Email 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
Email katsura-thk@umin.ac.jp

Sponsor
Institute Department of Psychiatry, Tohoku University Graduate School of Medicine
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009582

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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