UMIN-CTR Clinical Trial

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
Email	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
Email	n-kawano@oita-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry Oita University faculty of medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031565