UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037271 |
|---|---|
| Receipt number | R000042495 |
| Scientific Title | Effects of Mindfulness-Based Cognitive Therapy on suicidal ideation. |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2021/09/03 14:26:27 |
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Basic information
Public title
Effects of Mindfulness-Based Cognitive Therapy on suicidal ideation.
Acronym
Effects of MBCT on suicidal ideation.
Scientific Title
Effects of Mindfulness-Based Cognitive Therapy on suicidal ideation.
Scientific Title:Acronym
Effects of MBCT on suicidal ideation.
Region
| Japan |
Condition
Condition
Suicide ideation
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effect of Mindfulness-Based Cognitive Therapy on Japanese adult who have suicide ideation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Defeat: Defeat scale in Defeat and Entrapment Scale Japanese version(in development)
2. Entrapment: Internal Entrapment scale and External Entrapment scale in Defeat and Entrapment Scale Japanese version(in development)
3. Suicidal ideation: Suicidal ideation scale Japanese version(Otsuka, Seto, Kanno, & Agari, 1998)
4. Trait mindfulness: Five Facet Mindfulness Questionnaire Japanese version(Sugiura, Sato, Ito & Murakami, 2012)
5. Overgeneral autobiographical memory: The Sentence Completion for Events from the Past Test Forced Choice version Japanese version (Matsumoto, Ochi, & Mochizuki, 2013)
Key secondary outcomes
1. Self Compassion: Self Compassion Scale Short Form Japanese version(Tomimura, Koda, Ito, & Sato, 2012)
2. Psychological inflexibility: Acceptance and Action Questionnaire II Japanese version(Shima, Yanagihara, Kawai, & Kumano, 2013)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Mindfulness-Based Cognitive Therapy
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The individual who have high level of suicidal ideation.
Key exclusion criteria
1. Receiving psychotherapy currently.
2. Having diagnoses of the schizophrenia or any type of personality disorder, or having a salient feature of those diagnoses.
3. Having significant mental distress or extreme traumatic experiences now or previous to intervention.
4. Having an extremely high suicidal ideation.
5. Those who do not have the doctor's permission when they have been diagnosed by a doctor for mental illness.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
University of the Ryukyus
Division name
Faculty of Humanities and Social Science
Zip code
903-0213
Address
1, Senbaru, Nishihara-tyou, Okinawa-ken, 903-0213, Japan
TEL
098-895-8423
gitoku@edu.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Nanami |
| Middle name | |
| Last name | Tomori |
Organization
University of the Ryukyus
Division name
Graduate school of Humanities and Social Sciences
Zip code
903-0213
Address
1, Senbaru, Nishihara-tyou, Okinawa-ken, 903-0213, Japan
TEL
098-895-8423
Homepage URL
MBCT.jim2019@gmail.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus
Address
1, Senbaru, Nishihara-tyou, Okinawa-ken, 903-0213, Japan
Tel
098-895-8016
knknkyu@to.jim.u-ryukyu.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
| 2019 | Year | 07 | Month | 04 | 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 | 07 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | 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 | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042495
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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