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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044244
Receipt No. R000050528
Scientific Title Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia : Additional study for the control group in the RCT(UMIN000043396)
Date of disclosure of the study information 2021/05/19
Last modified on 2021/05/18

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Basic information
Public title Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia : Additional study for the control group in the RCT(UMIN000043396)
Acronym Cognitive Behavioral Therapy for schizophrenia : Additional study for the control group in the RCT(UMIN000043396)
Scientific Title Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia : Additional study for the control group in the RCT(UMIN000043396)
Scientific Title:Acronym Cognitive Behavioral Therapy for schizophrenia : Additional study for the control group in the RCT(UMIN000043396)
Region
Japan

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

Objectives
Narrative objectives1 To verify whether cognitive-behavioral therapy is effective for patients who participated as a control group in a randomized controlled trial of video-conference cognitive-behavioral therapy in patients with schizophrenia.
Basic objectives2 Others
Basic objectives -Others Increasing the number of participants in clinical trials can provide more evidence for research trials.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase II

Assessment
Primary outcomes Positive and Negative Syndrome Scale (PANSS)
Pre vCBTp
Post vCBTp
Key secondary outcomes Japanese version of The Beck Cognitive Insight Scale (BCIS-J)
Impact of Event Scale-Revised (IES-R)
Euro Qol 5 Dimension 5 level (EQ-5D-5L)
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder-7 (GAD-7)
Pre vCBTp
Post vCBTp

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
Maneuver
Interventions/Control_1 cognitive behavioral therapy(7weeks)
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients who meet the diagnostic criteria for schizophrenia in DSM-5
(2) About Positive and Negative Symptom Scale (PANSS), those who have 3 or more points out of 7 points for any one of the 7 items of Positive Symptom
(3) Patients who are recognized as having the ability to consent to this study in MacCAT-CR (The MacArthur Competence Assessment Tool for Clinical Research)
(4) Patients who have taken antipsychotic drugs constantly for 3 months or more and are not planning to change their drugs for the next 3 months
(5) Patients who have the ability and environment to use the Internet and computers to receive video-conference based cognitive behavioral therapy for psychosis (vCBTp)
Key exclusion criteria (1) Patients with serious addiction and substance addiction such as alcohol or drug addiction
(2) Patients with mental retardation, those with neurocognitive impairment (dementia), those with autism spectrum disorder
(3) Patients who are at risk of imminent suicide and are expected to discontinue cognitive behavioral therapy
(4)Patients who are predicted to be at risk of self-harm or other harmful behavior due to worsening symptoms
(5)Patients who are in the hospital
(6)Patients who failed to complete participation in the clinical trial (UMIN000043396) assigned to the control group
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Shimizu
Organization Graduate School of Medicine Chiba University
Division name Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code 260-8670
Address 1-8-1 Inohana,Chuouku,Chiba,Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Katsushima
Organization Graduate School of Medicine Chiba University
Division name Department of Cognitive Behavioral Physiology
Zip code 260-8670
Address 1-8-1 Inohana,Chuouku,Chiba,Japan
TEL 043-226-2027
Homepage URL
Email axaa4738@chiba-u.jp

Sponsor
Institute Research Center for Child Mental Development,Department of Cognitive Behavioral Physiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba university certified clinical research board
Address 1-8-1 Inohana,Chuouku,Chiba,Japan
Tel 043-222-7171
Email hsp-chibacrc@chiba-u.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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 19 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 Open public recruiting
Date of protocol fixation
2021 Year 04 Month 15 Day
Date of IRB
2021 Year 04 Month 15 Day
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2023 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
2021 Year 05 Month 18 Day
Last modified on
2021 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050528

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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