UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of Cognitive Behavioral Therapy for Psychosis in Japan
Acronym	Feasibility study of Cognitive Behavioral Therapy for Psychosis in Japan
Scientific Title	Feasibility study of Cognitive Behavioral Therapy for Psychosis in Japan
Scientific Title:Acronym	Feasibility study of Cognitive Behavioral Therapy for Psychosis in Japan
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish a practical training system and test feasibility of Cognitive Behavioral Therapy for Psychosis in Japan
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Total 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) Auditory hallucination scale and delusions scale of PSYRATS (Psychotic Symptom Rating Scales) GAF (The Global Assessment of Functioning) SOFAS (Social and Occupational Functioning Assessment Scale) MINI International Neuropsychiatric Interview PSP(Personal and Social Performance Scale) ODSIS (Overall Depression Severity and Impairment Scale) OASIS (Overall Anxiety Severity and Impairment Scale) WHO-QOL26 CBQp (Cognitive Biases Questionnaire for Psychosis) BCSS (Brief Core Schema Scale) Suicidality and self harm on CAARMS Aggression/Dangerous Behavior on CAARMS

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 Psychosis
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	A) Patients with schizophrenia according to DSM-5 criteria B) PANSS total score at 60 points or more C) Age : 20-59 years-old D) Out patients E) No hospitalization during the 6 months prior to the trial F) Native Japanese speaker G) Subjects who give full consent in the participation of the study
Key exclusion criteria	A) Organic mental disorder B) Alcohol / drug related disorder C) Intellectual Disabilities (DSM-5), Specific Learning Disorder (DSM-5) D) Existing serious suicidal ideation or dangerous behavior
Target sample size	13

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Matsumoto
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code	980-8574
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 Emi Middle name Last name Sunakawa
Organization	Tohoku University Hospital
Division name	Department of Psychiatry
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7262
Homepage URL
Email	sunakawa-tuh@umin.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	the Grant-in-Aid for Young Scientists(B)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Psychiatry, Tohoku University Hospital Department of Preventive Psychiatry, Tohoku University Graduate School of Medicine
Name of secondary funder(s)	Donation

IRB Contact (For public release)
Organization	Clinical Research, Innovation and Education Center, Tohoku University Hospital
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
Tel	0227284105
Email	rinri-2@proj.med.tohoku.ac.jp

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	2015 Year 09 Month 25 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	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 26 Day
Date of IRB	2015 Year 11 Month 24 Day
Anticipated trial start date	2016 Year 03 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 24 Day
Last modified on	2020 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022084