UMIN-CTR Clinical Trial

Basic information
Public title	Effects of participatory intervention for improving the psychosocial work environment on mental health among nurses: a cluster randomized controlled trial (Methodological investigation of organization-directed intervention for the stress management for nurses)
Acronym	Cluster RCT of participatory intervention on psychosocial work environment among nurses
Scientific Title	Effects of participatory intervention for improving the psychosocial work environment on mental health among nurses: a cluster randomized controlled trial (Methodological investigation of organization-directed intervention for the stress management for nurses)
Scientific Title:Acronym	Cluster RCT of participatory intervention on psychosocial work environment among nurses
Region	Japan

Condition
Condition	depressive symptoms
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effects of participatory intervention for improving the psychosocial work environment aimed at stress prevention among nurses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of indicator related to mental health at 6 months or 12 months after the start of intervention.
Key secondary outcomes	Changes of indicators related to psychosocial work environment at 6 months or 12 months after the start of intervention.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group; Implementation of activities for improving the psychosocial work environment over 3 months. Thirty minutes group meeting and man-to-man interview once a month. 1. Identify current situation 2. Discuss and suggest action plan 3. Follow-up progress of activities
Interventions/Control_2	Control group; Routine practice except for questionnaire survey before and after intervention.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Nurses working in hospital 2. Respondents to questionnaire survey 3. Study participants with consent 4. Nurses belonging to units involving direct patients care
Key exclusion criteria	1. Non-Responders to questionnaire survey 2. Study participants without consent 3. Nurses belonging to units involving indirect patients care
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ayako Uchiyama
Organization	Tokyo Medical University
Division name	Department of Preventive Medicine and Public Health
Zip code
Address	6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-3351-6141(ext.237)
Email

Public contact
Name of contact person	1st name Middle name Last name Ayako Uchiyama
Organization	Tokyo Medical University
Division name	Department of Preventive Medicine and Public Health
Zip code
Address	6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Department of Preventive Medicine and Public Health, Tokyo Medical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2010 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results	Published

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	2009 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date	2009 Year 08 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 21 Day
Last modified on	2013 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005297

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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