UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043396 |
|---|---|
| Receipt number | R000049544 |
| Scientific Title | Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia :Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/11/08 18:16:59 |
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Basic information
Public title
Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia :Pilot Randomized Controlled Trial
Acronym
Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia
Scientific Title
Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia :Pilot Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of video-conference based Cognitive Behavioral Therapy for schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify that the video-conference based cognitive behavioral therapy for psychosis (vCBTp) is significantly more effective than treatment as usual (TAU).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
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
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Video-conference based cognitive behavioral therapy for psychosis(7weeks)
Interventions/Control_2
Treatment as usual(7weeks)
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 schizoaffective disorder, or delusional disorder 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)
(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
Target sample size
24
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
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
axaa4738@chiba-u.jp
Sponsor or person
Institute
Research Center for Child Mental Development,Department of Cognitive Behavioral Physiology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
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 | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | 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 | 02 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049544
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