UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035809 |
|---|---|
| Receipt number | R000040794 |
| Scientific Title | An examination of mechanism variables of mindfulness group therapy for depression and anxiety |
| Date of disclosure of the study information | 2019/02/08 |
| Last modified on | 2019/02/08 00:34:00 |
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Basic information
Public title
An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Acronym
An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Scientific Title
An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Scientific Title:Acronym
An examination of mechanism variables of mindfulness group therapy for depression and anxiety
Region
| Japan |
Condition
Condition
depression, anxiety
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine what are the mechanism variables of eight-week mindfulness group therapy for people who complain of depression and anxiety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Below outcomes after the intervention and at 2-month follow-up
Japanese Version of Beck Depression Inventory-2
Japanese Version of State-Trait Anxiety Inventory
Key secondary outcomes
Below outcomes after the intervention and at 2-month follow-up
Japanese Version of Mindful Attention Awareness Scale
Japanese Version of Mind-Wandering Questionnaire
Japanese version of Daydream Frequency Scale
Japanese version of Cognitive Fusion Questionnaire (7-item version)
Japanese version of Acceptance and Action Questionnaire-II
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Eight-week mindfulness program
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People who complain of depression or anxiety
Key exclusion criteria
/being with schizophrenia, ASD, ADHD, OCD, or PTSD
/too severe symptoms to participate in a group therapy, e.g., high suicidal risk
/not permitted to participate by the applicant's attending physician if the participant has an attending physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kumano |
Organization
Waseda University
Division name
Faculty of Human Science
Zip code
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
hikumano@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Takahashi |
Organization
Waseda University
Division name
Graduate School of Human Science
Zip code
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
Other
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
| 2019 | Year | 02 | Month | 08 | 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
| 2016 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040794
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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