UMIN-CTR Clinical Trial

Basic information
Public title	Effects of workers' interpersonal helping behavior enhancement program to raise social support
Acronym	Effects of workers' interpersonal helping behavior enhancement program to raise social support
Scientific Title	Effects of workers' interpersonal helping behavior enhancement program to raise social support
Scientific Title:Acronym	Effects of workers' interpersonal helping behavior enhancement program to raise social support
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine whether a workers' interpersonal helping behavior enhancement program raises social support and work engagement, enhances interpersonal helping behavior, vigor, quantitative workload, interpersonal relationships at work, job reward, leadership, interactional justice, workplace where people compliment each other, and workplace social capital, and reduces psychological distress.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Social support Work engagement
Key secondary outcomes	Interpersonal helping behavior Vigor Quantitative workload Interpersonal relationships at work Job reward Leadership Interactional justice Workplace where people compliment each other Workplace social capital Psychological distress

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	psychological education and discussion about interpersonal helping behavior in about seventy minutes homework about interpersonal helping behavior in about five minutes for four weeks discussion about interpersonal helping behavior in about sixty minutes Participants answer a questionnaire about primary outcomes and key secondary outcomes four times during the four months study period.
Interventions/Control_2	Participants answer a questionnaire about primary outcomes and key secondary outcomes four times during the four months study period.
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	Age 20-60 at study entry Nurse
Key exclusion criteria	Sick leave for 15 or more days for a physical or mental condition in the past 3 months
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Horita
Organization	Faculty of Education Shujitsu University
Division name	Department of Education and Psychology
Zip code	703-8516
Address	1-6-1 Nishigawara, Naka-ku,Okayama, Japan
TEL	086-271-8111
Email	yuji-horita@umin.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Horita
Organization	Faculty of Education Shujitsu University
Division name	Department of Education and Psychology
Zip code	703-8516
Address	1-6-1 Nishigawara, Naka-ku,Okayama, Japan
TEL	086-271-8111
Homepage URL
Email	yuji-horita@umin.ac.jp

Sponsor
Institute	Faculty of Education Shujitsu University
Institute
Department

Funding Source
Organization	MHLW(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research ethics committee in Shujitsu University
Address	1-6-1 Nishigawara, Naka-ku,Okayama, Japan
Tel	086-271-8111
Email	matsubara@shujitsu.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	2018 Year 07 Month 05 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 07 Month 05 Day
Date of IRB	2018 Year 05 Month 24 Day
Anticipated trial start date	2018 Year 07 Month 05 Day
Last follow-up date	2018 Year 11 Month 10 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 07 Month 04 Day
Last modified on	2019 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037946