UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027537 |
|---|---|
| Receipt number | R000031565 |
| Scientific Title | A comparison of mindfullness therapy with existential approach and without: randomized controlled study in healthy volunteers |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2021/09/27 13:10:37 |
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Basic information
Public title
A comparison of mindfullness therapy with existential approach and without: randomized controlled study in healthy volunteers
Acronym
A comparison of mindfullness therapy with existential approach and without: randomized controlled study in healthy volunteers
Scientific Title
A comparison of mindfullness therapy with existential approach and without: randomized controlled study in healthy volunteers
Scientific Title:Acronym
A comparison of mindfullness therapy with existential approach and without: randomized controlled study in healthy volunteers
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects on existence between mindfullness therapy with existential approach and without
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-Compassion Scale-Japanese version: SCS-J
Key secondary outcomes
Beck Depression Inventory: BDI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
4 week Mindfulness and 4 week Existential approach
Interventions/Control_2
8 week Mindfulness
Interventions/Control_3
8 week waiting list
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults providing written informed consent
Key exclusion criteria
Those who are thought to be difficult to continue research due to serious mental illness or physical illness
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Terao |
| Middle name | |
| Last name | Takeshi |
Organization
Department of Neuropsychiatry Oita University faculty of medicine
Division name
Psychiatry
Zip code
879-5503
Address
1-1 Hasamamachiidaigaoka,Yufu,Oita
TEL
097-586-5823
seisin@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Kawano |
Organization
Department of Neuropsychiatry Oita University faculty of medicine
Division name
Psychiatry
Zip code
879-5503
Address
1-1 Hasamamachiidaigaoka,Yufu,Oita
TEL
097-586-5823
Homepage URL
n-kawano@oita-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry Oita University faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Public funds of research director (donation - research grant - academic research grant)
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
General Clinical Research Center, Oita University Hospital
Address
1-1 Hasamamachiidaigaoka,Yufu,Oita
Tel
097-586-6163
gcrcjimu@oita-u.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
| 2017 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.3389/fpsyt.2019.00538
Number of participants that the trial has enrolled
200
Results
Both MBI and EXMIND groups had significantly increased SCS total scores compared to those of the waiting group, with mean SCS total scores of 2.3 (SD 3.0) in the MBI group and 2.1 (2.9) in the EXMIND group versus 0.3 (2.2) in the waiting group.
Our findings suggest that MBI followed by existential approach are not antagonistic and may have cooperative effects, suggesting that EXMIND may be a useful treatment.
Results date posted
| 2019 | Year | 12 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 02 | Day |
Baseline Characteristics
4-week mindfulness-based intervention followed by 4-week existential approach(EXMIND) group:
age (SD):48.4(12.6)
sex :M/F:11/52
8-week mindfulness-based intervention(MBI) group:
age (SD):49.6(11.6)
sex :M/F:11/50
waiting-list group:
age (SD):51.1(14.1)
sex :M/F:5/26
Participant flow
All participants provided written informed consent.
We assigned 152 participants to the intervention group (n = 116) and the waiting-list group (n = 36). 12 of the waiting-list group dropped out. Of the waiting-list group, 24 waiting completers entered the intervention group (n = 140). Excluding three cancellers, 137 participants were randomized to the EXMIND group (n = 69) or the MBI group (n = 68). Six of the EXMIND group and seven of the MBI group dropped out. 63 (91.3%) participants completed the EXMIND whereas 61 (89.7%) participants completed the MBI.
Adverse events
None
Outcome measures
Self-Compassion Scale-Japanese version (SCS-J)
Beck Depression Inventory (BDI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 27 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031565
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