UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045366 |
|---|---|
| Receipt number | R000051783 |
| Scientific Title | Effectiveness of Mindfulness-Based Cognitive Therapy for suicidal ideation in psychiatric outpatients. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/09/03 14:40:43 |
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Basic information
Public title
Mindfulness-based cognitive therapy for coping with the feeling of "wanting to die."
Acronym
Mindfulness-based cognitive therapy for coping with the feeling of "wanting to die."
Scientific Title
Effectiveness of Mindfulness-Based Cognitive Therapy for suicidal ideation in psychiatric outpatients.
Scientific Title:Acronym
Effectiveness of MBCT for suicidal ideation in psychiatric outpatients.
Region
| Japan |
Condition
Condition
Psychiatric patients with suicidal ideation
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of MBCT on suicidal ideation and the psychological processes that enhance it in outpatients with psychiatric disorders with suicidal ideation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defeat and Entrapment Scale
Suicidal Ideation Scale
Key secondary outcomes
Five Facet Mindfulness Questionnaire
Self-Compassion Scale-Short Form
Acceptance and Action Questionnaire-II
Repetitive Thinking Questionnaire-10
K6
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Over 20 years old
(2) Have current thoughts of death, or have had thoughts of death in the past and still think about it from time to time.
3) Able to participate in the online program for 8 sessions (120 minutes each week) starting in January.
(4) Accessible from a PC or smart phone with Wi-Fi access.
4) Accessible from PC or smartphone, and Wi-Fi environment is available.
(5) Participation seems to be effective for patients.
Key exclusion criteria
(1) Under 20 years old
(2) Currently having strong thoughts of suicide, such as making a specific plan.
(3) Have a diagnosis of schizophrenia, personality disorder, or dementia.
(4) Considered inappropriate to participate.
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 Humanity and Social Science
Zip code
903-0213
Address
1 Senbaru, Nishihara, Okinawa, 903-0213, Japan
TEL
098-895-8423
gitoku@hs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Aniya |
Organization
University of the Ryukyus
Division name
Faculty of Education
Zip code
903-0213
Address
1Senbaru, Nishihara, Okinwa, 903-0213, Japan
TEL
098-895-8445
Homepage URL
MBCT.jim2021@gmail.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
1Senbaru, Nishihara, Okinwa, 903-0213, Japan
Tel
098-895-8423
gitoku@hs.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
| 2021 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | 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
| 2021 | Year | 09 | Month | 03 | 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=R000051783
