UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015412 |
|---|---|
| Receipt number | R000017846 |
| Scientific Title | Effectiveness and Cost effectiveness of mindfulness class for anxiety disorders |
| Date of disclosure of the study information | 2014/10/15 |
| Last modified on | 2018/03/24 14:51:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness and Cost effectiveness of mindfulness class for anxiety disorders
Acronym
Effectiveness and Cost effectiveness of mindfulness class for anxiety disorders
Scientific Title
Effectiveness and Cost effectiveness of mindfulness class for anxiety disorders
Scientific Title:Acronym
Effectiveness and Cost effectiveness of mindfulness class for anxiety disorders
Region
| Japan |
Condition
Condition
Anxiety disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether Mindfulness class for the patients with anxiety disorders (panic disorder, agoraphobia, and social anxiety disorder) is effective and cost effective compared to the control group or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Difference of STAI score between both groups
Key secondary outcomes
Panic Disorder Severity Scale, Morbility Inventory for Agoraphobia, LSAS-J, CES-D, K-6, EQ-5D, SF-36, Japanse version Five Facet Mindlfulness Questionnaire, SAA, healthcare service use, and adherence to medication.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness class
Interventions/Control_2
Treatment as usual
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 SCID.
Key exclusion criteria
/Past history of substance related disorders
/Alcohol dependence
/Drug dependence
/Anti social personality disorder
/Severe suicidal ideation or self-harm behaviour
/Difficult to follow up for 8 weeks after start of intervention
/Dissent to the possibility of being allocated to the control group
/Organic brain disorders
/Other severe general medical conditions
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joichiro Shirahase |
Organization
Keio University
Division name
Center for Stress Research
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
shirahase@z6.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Sado |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
Homepage URL
mitsusado@z5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
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
Address
Tel
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
| 2014 | Year | 10 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 11 | Day |
Last modified on
| 2018 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017846
