UMIN-CTR Clinical Trial

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
Email	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
Email	MBCT.jim2019@gmail.com

Sponsor
Institute	University of the Ryukyus
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042495