UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the treatment mechanisms of the mindfulness program
Acronym	Investigation of the treatment mechanisms of the mindfulness program
Scientific Title	Investigation of the treatment mechanisms of the mindfulness program
Scientific Title:Acronym	Investigation of the treatment mechanisms of the mindfulness program
Region	Japan

Condition
Condition	Depression, anxiety
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether a 8-week mindfulness program for the patients with depression and/or anxiety is effective or not
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference in mean change scores at 8 weeks from baseline on the Beck depression inventory-2 between the groups.
Key secondary outcomes	The difference in mean change scores at 8 weeks from baseline on STAI-T, FFMQ, MAIA, SCS, PTQ, MWQ, EEG, meditation task, sustained attention to response test, emotion report task between the groups.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	8-sessions mindfulness program
Interventions/Control_2	No interventions (waiting-list)
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	People who complains depression or anxiety.
Key exclusion criteria	/diagnosed by ASD, ADHD, intellectual disability, OCD, bipolar 1 disorder, PTSD, schizophrenia(including past), alcohol dependence, drag dependence, BPD /having brain disorder /having severe physical disorder /experience of participating in 8-sessions mindfulness program and/or long-term meditation /dissent to the possibility of being allocated to the control group
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Kumano
Organization	Waseda University
Division name	Faculty of Human Science
Zip code	359-1192
Address	2-579-15, Mikajima, Tokorozawa, Saitama
TEL	04-2949-8113
Email	hikumano@waseda.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Takahashi
Organization	Waseda University
Division name	Graduate School of Human Science
Zip code	359-1192
Address	2-579-15, Mikajima, Tokorozawa, Saitama
TEL	04-2949-8113
Homepage URL
Email	totakahashi@akane.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Office of Research Ethics concerning Research with Human Subjects
Address	1-104, Totsuka-machi, Shinjuku-ku, Tokyo
Tel	03-5272-1639
Email	rinri@list.waseda.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	2018 Year 11 Month 02 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	2018 Year 11 Month 02 Day
Date of IRB	2018 Year 09 Month 21 Day
Anticipated trial start date	2018 Year 11 Month 02 Day
Last follow-up date	2020 Year 07 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 02 Day
Last modified on	2021 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039635