UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040538 |
|---|---|
| Receipt number | R000046251 |
| Scientific Title | Development and effectiveness of computerized Cognitive Bias Modification for Interpretation (CBM-I) using text-based scenarios training and picture-word cue training |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2022/04/01 12:32:09 |
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Basic information
Public title
Development and effectiveness of computerized Cognitive Bias Modification for Interpretation (CBM-I) using text-based scenarios training and picture-word cue training
Acronym
Development and effectiveness of computerized Cognitive Bias Modification for Interpretation (CBM-I) using text-based scenarios training and picture-word cue training
Scientific Title
Development and effectiveness of computerized Cognitive Bias Modification for Interpretation (CBM-I) using text-based scenarios training and picture-word cue training
Scientific Title:Acronym
Development and effectiveness of computerized Cognitive Bias Modification for Interpretation (CBM-I) using text-based scenarios training and picture-word cue training
Region
| Asia(except Japan) |
Condition
Condition
Social Anxiety Disorder
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The current study investigated the effects of the Japanese version of CBM-I using text-based scenarios training and picture-word cue training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Liebowitz Social Anxiety Scale (LSAS-J)
(Pre intervention, post intervention, 1 month follow-up.)
Key secondary outcomes
Social Cost/Probability Scale
The Japanese version of the BDI-II
Japanese version of Brief, Momentary mood Checklists The interpretation bias scale, the Ambiguous Situation Interpretation Questionnaire
(Pre intervention, post intervention, 1 month follow-up.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
At one-week program with online session, participants received positive sentence training(four times) and positive picture-word cue training(three times). In both trainings, Positive outcome were presented following an ambiguous stimulus.
Interventions/Control_2
Participants in the control condition completed the same positive interpretation task after a one-week standby.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
undergraduate student
graduate student
Web accessible
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Sensui |
Organization
Saitama Gakuen University
Division name
Faculty of Humanities, Department of Psychology
Zip code
333-0831
Address
1510, Kizoro, Kawaguchi, Saitama, Japan
TEL
048-294-1110
t.sensui@saigaku.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Sensui |
Organization
Saitama Gakuen University
Division name
Faculty of Humanities, Department of Psychology
Zip code
333-0831
Address
1510, Kizoro, Kawaguchi, Saitama, Japan
TEL
048-294-1110
Homepage URL
t.sensui@saigaku.ac.jp
Sponsor or person
Institute
Saitama Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Research Ethics Committee, Saitama Gakuen University
Address
1510, Kizoro, Kawaguchi, Saitama, Japan
Tel
048-294-1110
daigakuin@saigaku.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16K17341/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16K17341/
Number of participants that the trial has enrolled
120
Results
In this study, we developed a Japanese version of CBM-I. As a results, in the positive condition, there was a significant reduction in negative affect compared to the control condition. In addition, there were greater reductions in negative affect, social evaluative fear, and negative interpretation bias at a one-month follow-up, irrespective of condition. Results suggest that text-based CBM-I affects interpretation bias and picture-based CBM-I especially affects these emotional characteristics.
Results date posted
| 2022 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
university student
Participant flow
120 participants were randomized into one-week online sessions of text-based scenarios training (four times) and picture-word cue training (three times) or a control condition. Participants in the control condition completed the same positive interpretation task after a one-week standby.
Adverse events
none
Outcome measures
Japanese version of the Liebowitz Social Anxiety Scale
Japanese version of the BDI-II
the Ambiguous Situation Interpretation Questionnaire
Social Cost/ Probability bias scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046251
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