UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038337 |
|---|---|
| Receipt number | R000043691 |
| Scientific Title | Elucidation of action mechanisms of mindfulness group therapy |
| Date of disclosure of the study information | 2019/10/19 |
| Last modified on | 2021/08/07 20:55:20 |
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Basic information
Public title
Elucidation of action mechanisms of mindfulness group therapy
Acronym
Elucidation of action mechanisms of mindfulness group therapy
Scientific Title
Elucidation of action mechanisms of mindfulness group therapy
Scientific Title:Acronym
Elucidation of action mechanisms of mindfulness group therapy
Region
| Japan |
Condition
Condition
Depression, anxiety
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how 8-week mindfulness group therapy affects the patients with depression and/or anxiety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in mean change scores at 8 weeks from baseline on the Beck depression inventory-2 between the groups.
Key secondary outcomes
The difference in mean change scores at 8 weeks from baseline on STAI-T, FFMQ, MAIA, SCS, PTQ, MWQ, SF-36 (mental health sub-scale), FCS, EMA (SC, FC, mindfulness), EEG, meditation task, sustained attention to response test between the groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
8-sessions mindfulness group therapy
Interventions/Control_2
No interventions (waiting-list)
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who complains depression or anxiety
Key exclusion criteria
/diagnosed by ASD, ADHD, intellectual disability, OCD, bipolar 1 disorder, PTSD, schizophrenia(including past), alcohol dependence, drag dependence, eating disorder, BPD
/having brain disorder
/having severe physical disorder
/experience of participating in 8-sessions mindfulness program and/or long-term meditation
/dissent to the possibility of being allocated to the control group
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kumano |
Organization
Waseda University
Division name
Faculty of Human Science
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
hikumano@waseda.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Takahashi |
Organization
Waseda University
Division name
Graduate School of Human Science
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
Homepage URL
totakahashi@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Research Ethics concerning Research with Human Subjects
Address
1-104, Totsuka-machi, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2019 | Year | 10 | Month | 19 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043691
