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
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
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
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
