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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040571
Receipt No. R000046306
Scientific Title Development and Effectiveness of Computerized Cognitive Bias Modification for Interpretation(CBM-I)
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/28

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Basic information
Public title Development and Effectiveness of Computerized Cognitive Bias Modification for Interpretation(CBM-I)
Acronym Development and Effectiveness of Computerized Cognitive Bias Modification for Interpretation(CBM-I)
Scientific Title Development and Effectiveness of Computerized Cognitive Bias Modification for Interpretation(CBM-I)
Scientific Title:Acronym Development and Effectiveness of Computerized Cognitive Bias Modification for Interpretation(CBM-I)
Region
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 The Japanese version of the Social Interaction Anxiety Scale (SIAS-J)
(Pre intervention, post intervention, 1 month follow-up.)
Key secondary outcomes Social Cost/Probability Scale
The Japanese version of the BDI-2
The Japanese version of the STAI-T
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 YES
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 For a bias modification approach for positive interpretations, subjects received positive sentence training, where interpersonal scenarios and positive outcomes were presented in a week a long, everyday.
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 80

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name Terashima
Last name Terashima
Organization Wayo Women's University
Division name Faculty of Humanities, Department of Psychology
Zip code 2728533
Address 2-3-1, Konodai, Ichikawa, Chiba, Japan
TEL 047-371-1981
Email h-terashima@wayo.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Terashima
Organization Wayo Women's University
Division name Faculty of Humanities, Department of Psychology
Zip code 2728533
Address 2-3-1, Konodai, Ichikawa, Chiba, Japan
TEL 047-371-1981
Homepage URL
Email h-terashima@wayo.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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 Ethics committee of the Faculty of Human Sciences, University of Tsukuba
Address 1-1-1, Tennnodai, Tsukuba, Ibaraki, Japan
Tel 029-853-5605
Email hitorinri@un.tsukuba.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-24730569/
Publication of results Partially published

Result
URL related to results and publications https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-24730569/
Number of participants that the trial has enrolled 78
Results Cognitive Bias Modification for Interpretation(CBM-I) is a method of presenting ambiguous and positive consequences repeatedly by computer to modify negative bias. I developed the Japanese version of CM-I by referring to previous studies and investigated the efficacy of it. Japanese university students (N=74) practiced CBM-I for one week. After the intervention, BDI-2 scores and negative interpretations decreased and positive interpretation increased.
Results date posted
2020 Year 05 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics University Students
Participant flow We introduced this study to about 500 students, 90 of whom agreed to participate.
For those who expressed interest in participation, the research explanation was given on the website and informed consent was obtained.
After obtaining the consent, subjects were asked to complete a pre-interventional questionnaire developed with online survey.
A total of 74 students completed the pre-questionnaire. The 74 students were randomly assigned to an experimental (n = 37) or a control group (n = 37).
After 1 week intervention, subjects were asked to complete a post-interventional questionnaire developed with online survey.A total of 68 students completed the interventional questionnaire.
Participants in the control condition completed the same intervention task after a one-week standby. After 1 week intervention, subjects were asked to complete a post-interventional questionnaire. A total of 33 students completed the interventional questionnaire.
A total of 66 students completed follow-up questionnaire at 1 month after.
Adverse events None
Outcome measures The Japanese version of the Social Interaction Anxiety Scale (SIAS-J)
Social Cost/Probability Scale
The Japanese version of the BDI-2
The Japanese version of the STAI-T
The interpretation bias scale, the Ambiguous Situation Interpretation Questionnaire
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 05 Month 14 Day
Date of IRB
2013 Year 06 Month 04 Day
Anticipated trial start date
2013 Year 06 Month 04 Day
Last follow-up date
2013 Year 08 Month 13 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 28 Day
Last modified on
2020 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046306

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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