UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048112 |
|---|---|
| Receipt number | 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 | 2024/08/02 08:39:43 |
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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
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
akira-ninomiya@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Suspended
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
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054816
