UMIN-CTR Clinical Trial

Basic information
Public title	Development of menopausal symptom management for working women in climacteric states
Acronym	Menopausal symptom management for working women in climacteric states
Scientific Title	Development of menopausal symptom management using internet-based cognitive behavioral therapy for working women in climacteric states
Scientific Title:Acronym	Menopausal symptom management using internet-based cognitive behavioral therapy for working women
Region	Japan

Condition
Condition	Symptoms of menopause
Classification by specialty	Obsterics and gynecology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims are to develop a management program of symptoms of menopause for working women and to examine its feasibility and effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Labor productivity after 12 weeks of intervention
Key secondary outcomes	1)Symptoms on menopause after 12 weeks of intervention 2)Work Engagement after 12weeks of intervention. 3)Self-care behavior for symptoms of menopause after 12 weeks of intervention.

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group E-learning about menopausal and cognitive behavioral therapy with workshop in a small group, and 4-weeks Internet-based cognitive behavioral therapy.
Interventions/Control_2	Control group No education
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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	1) having a job 2) who having at least a smartphone, a tablet terminal, or a personal computer. 3) are able to read and write Japanese.
Key exclusion criteria	1) having been receiving a treatment for a psychiatric disorder 2) has been working less than 4 hours a day 3) has been participating in other intervention research regarding with menopausal symptoms
Target sample size	480

Research contact person
Name of lead principal investigator	1st name Mikako Middle name Last name Yoshida
Organization	Tohoku University School of Medicine
Division name	Department of Wemen's Health Nursing & midwifery Course of Nursing, Health Science
Zip code	980-8575
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7956
Email	mikako.yoshida.e2@tohoku.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Hashimoto
Organization	Tohoku University School of Medicine
Division name	Department of Wemen's Health Nursing & midwifery Course of Nursing, Health Science
Zip code	980-8575
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7915
Homepage URL
Email	keiko.hashimoto.q8@dc.tohoku.ac.jp

Sponsor
Institute	Tohoku University School of Medicine
Institute
Department

Funding Source
Organization	Tohoku University School of Medicine
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	Tohoku University Graduate School of Medicine Ethics Committee
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel	022-728-4105
Email	med-kenkyo@grp.tohoku.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	2019 Year 10 Month 11 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	Preinitiation
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 09 Month 30 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 21 Day
Last modified on	2019 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042676