UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040571 |
|---|---|
| Receipt number | 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 18:32:19 |
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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
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
h-terashima@wayo.ac.jp
Sponsor or person
Institute
University of Tsukuba
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
Ethics committee of the Faculty of Human Sciences, University of Tsukuba
Address
1-1-1, Tennnodai, Tsukuba, Ibaraki, Japan
Tel
029-853-5605
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046306
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