UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019099
Receipt number R000022084
Scientific Title Feasibility study of Cognitive Behavioral Therapy for Psychosis in Japan
Date of disclosure of the study information 2015/09/25
Last modified on 2020/02/13 14:01:20

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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 or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name