UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of mindfulness-based stress reduction program for workers
Title of the study (Brief title)	Mindfulness program for workers
Region	Japan

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

Objectives
Narrative objectives1	To test the effect of mindfulness-based stress reduction program for workers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Depression and anxiety (Baseline and 8 weeks after starting intervention)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Eight weeks mindfulness program (90 min/session)
Interventions/Control_2	8 weeks usual life
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	Worker
Key exclusion criteria	serious psychiatric/neurological/internal disease, pregnant women, under any psychotherapy or counseling, and to judge industrial physicians as undesirable for this research
Target sample size	1500

Research contact person
Name of lead principal investigator	Shin Fukudo
Organization	Tohoku University
Division name	Department of Behavioral Medicine
Address	2-1 Seiryo, Aoba-Ku, Sendai
TEL	022-717-8214
Email	sfukudo@med.tohoku.ac.jp

Public contact
Name of contact person	Tomohiko Muratsubaki
Organization	Tohoku University
Division name	Department of Behavioral Medicine
Address	2-1 Seiryo, Aoba-Ku, Sendai
TEL	022-717-8162
Homepage URL
Email	t-mura@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	FUJIFILM Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 11 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 01 Day
Last modified on	2018 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034039