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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048112
Receipt No. R000054816
Scientific Title A mindfulness-based program with VR-based exposures -Effectiveness and cost-effectiveness of a randomized controlled feasibility trial-
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/20

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Basic information
Public title A mindfulness-based program with VR-based exposures for anxiety disorders
-Effectiveness and cost-effectiveness of a randomized controlled feasibility trial-
Acronym A mindfulness-based program with VR-based exposures
-a randomized controlled feasibility trial-
Scientific Title A mindfulness-based program with VR-based exposures
-Effectiveness and cost-effectiveness of a randomized controlled feasibility trial-
Scientific Title:Acronym A mindfulness-based program with VR-based exposures
-a randomized controlled feasibility trial-
Region
Japan

Condition
Condition anxiety disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility, and effectiveness and cost-effectiveness of a mindfulness based intervention with VR-based exposure to anxiety disorders (panic disorder, agoraphobia, and social anxiety disorder) in a randomised controlled feasibility trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1) enrollment rate, 2) attrition rate, 3)attendance rate
Key secondary outcomes mean and standardized deviation of the following clinical parameters at baseline,4, 8, 16weeks : STAI,PAS, LSAS-J, Experiences Questionaire, RSES, FFMQ, CD-RISC, SCS, QIDS, PSS, HPQ, SWLS, FS, EQ-5D.

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 NO
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
Behavior,custom
Interventions/Control_1 8 weekly sessions of mindfulness-based program (mindfulness-based cognitive therapy) + 3 sessions of VR-based exposures
Interventions/Control_2 8 weekly sessions of mindfulness-based program (mindfulness-based cognitive therapy) only
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria /Diagnosed as panic disorder, agoraphobia, or social anxiety disorder, based on DSM-4
/ No remission after 4 week's pharmacotherapy
/Ability to consent in writing
Key exclusion criteria /Substance related disorders
/Severe suicidal ideation or self-harm behaviour
/Severe general medical conditions
/Unsuitable for participation in the research in the opinion of the principal investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name mitsuhiro
Middle name
Last name sado
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-0016
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL +81-(0)3-3353-1211
Email mitsusado@keio.jp

Public contact
Name of contact person
1st name akira
Middle name
Last name ninomiya
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-0016
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL +81-(0)3-3353-1211
Homepage URL
Email akira-ninomiya@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Education,Culuture,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 Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
Tel +81-(0)3-3353-1211
Email med-rinri-jimu@adst.keio.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
2022 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2022 Year 06 Month 09 Day
Date of IRB
2022 Year 06 Month 14 Day
Anticipated trial start date
2022 Year 06 Month 21 Day
Last follow-up date
2024 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
2022 Year 06 Month 20 Day
Last modified on
2022 Year 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054816

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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