UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Acronym	Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Scientific Title	Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Scientific Title:Acronym	Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine whether mindfulness meditation reduces mindlessness and causes changes in interpersonal attitudes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mindlessness Scale
Key secondary outcomes	1)Picture Frustration Study 2)The Japanese version of Five Facet Mindfulness Questionnaire 3)Homework Records

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	This study conduct lecture on mindfulness(psycho-education on mindfulness and mindfulness meditation, mindfulness meditation practice) of about one hour each for 8 weeks.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1)People who are at least 20 years old at the time of informed consent. 2)People willing and able to give informed consent.
Key exclusion criteria	1)People who have difficulty in verbal communication with the principle investigator or research member. 2)unable to understand psycho-education on mindfulness and the instruction of mindfulness meditation. 3)unable to reflect on and report changes in thoughts and feelings as a result of the intervention. 4)unable to understand and respond to the content of the measurement scales. 5)practice mindfulness meditation on the daily basis. 6)may cause dissociation or flashbacks when mindfulness meditation is practiced(e.g., Post-Traumatic Stress Disorder;Dissociative Disorder). 7)any condition which in the investigator's opinion, endangered the patient if he or she participated in this intervention.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name masahiko Middle name Last name inoue
Organization	Tottori University
Division name	Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code	683-8503
Address	86 Nishi-cho,Yonago-shi,Tottori Japan
TEL	0859386410
Email	masahiko-inoue@med.tottori-u.ac.jp

Public contact
Name of contact person	1st name kengo Middle name Last name Yuruki
Organization	Tottori University
Division name	Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code	683-8503
Address	86 Nishi-cho,Yonago-shi,Tottori Japan
TEL	0859386410
Homepage URL
Email	yurukikng.gel157@gmail.com

Sponsor
Institute	Tottori University
Institute
Department

Funding Source
Organization	Tottori University
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	Department of Clinical Psychology, Graduate School of Medical Sciences, Tottori University
Address	86 Nishi-cho,Yonago-shi,Tottori Japan
Tel	0859386410
Email	M20M4010A@edu.tottori-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	2022 Year 01 Month 24 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	19
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 01 Month 14 Day
Date of IRB	2022 Year 01 Month 05 Day
Anticipated trial start date	2022 Year 02 Month 07 Day
Last follow-up date	2022 Year 04 Month 11 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 01 Month 23 Day
Last modified on	2022 Year 04 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053276

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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