UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048781 |
|---|---|
| Receipt number | R000055575 |
| Scientific Title | Examination of the effects of online mindfulness classes on depression and anxiety |
| Date of disclosure of the study information | 2022/08/29 |
| Last modified on | 2022/12/26 21:17:59 |
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Basic information
Public title
Examination of the effects of online mindfulness classes on depression and anxiety
Acronym
Examination of the effects of online mindfulness classes on depression and anxiety
Scientific Title
Examination of the effects of online mindfulness classes on depression and anxiety
Scientific Title:Acronym
Examination of the effects of online mindfulness classes on depression and anxiety
Region
| Japan |
Condition
Condition
Depression, Anxiety
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of an online mindfulness intervention on depression and anxiety symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PHQ-9 and GAD-7 eight weeks after the start of the intervention
Key secondary outcomes
WHO-5, the short form of the five facet mindfulness questionnaire, the short form of the self-compassion scale, and the mind wandering: deliberate and spontaneous scales eight weeks after the start of the intervention
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
Eight-week online mindfulness classes
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
Persons who showed symptoms of either PHQ-9 or GAD-7 with a mild or higher score (5 or more).
Key exclusion criteria
-Persons with a diagnosis of ASD, ADHD, intellectual disability, obsessive-compulsive disorder, bipolar disorder, PTSD, schizophrenia, alcohol dependence, drug dependence, eating disorders, or personality disorders.
-Persons who have participated in mindfulness programs of 8 weeks or more in the past, persons who have been continuously doing practices like zazen and meditation over a long period of time (6 months or more), or persons who have registered for the services of the company implementing the intervention in this study.
-Persons who are under medical care and have not obtained permission from their doctor.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Takahashi |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
080-6549-1615
totakahashi@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Takahashi |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
080-6549-1615
Homepage URL
totakahashi@aoni.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
Waseda University Ethical Review Committee concerning Research with Human Subjects
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-182
Org. issuing International ID_1
Waseda University Ethical Review Committee concerning Research with Human Subjects
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 | 08 | Month | 29 | 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
| 2022 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 08 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055575
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
