UMIN-ICDS Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of Cognitive Behavioural Therapy for At-Risk Mental State in Japan: an open-label pilot study
Title of the study (Brief title)	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	Kazunori Matsumoto
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Psychiatry
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7262
Email	kaz-mat@umin.net

Public contact
Name of contact person	Masahiro Katsura
Organization	Tohoku University Hospital
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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