UMIN-CTR Clinical Trial

Basic information
Public title	Group video conference program based on acceptance and commitment therapy for young employee: A pre-post trial
Acronym	Group video conference program based on acceptance and commitment therapy for young employee: A pre-post trial
Scientific Title	Group video conference program based on acceptance and commitment therapy for young employee: A pre-post trial
Scientific Title:Acronym	Group video conference program based on acceptance and commitment therapy for young employee: A pre-post trial
Region	Japan

Condition
Condition	well-being
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the effect of the group video conference program based on acceptance and commitment therapy for young employee; Investigation of the feasibility of the program
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Well-being during the session from the start compared to baseline
Key secondary outcomes	Acceptance and Action Questionnaire-II; stress response; work engagement; the WHO Health and Work Performance Questionnaire; frequency of valued action; mental toughness

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	group acceptance and commitment therapy; 90 minutes, 3 sessions
Interventions/Control_2
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	none
Key exclusion criteria	none
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masao Middle name Last name Tsuchiya
Organization	ADVANTAGE Risk Management Co., Ltd.
Division name	Research Department
Zip code	153-0051
Address	17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
TEL	03-5794-3817
Email	mtsuchiya@armg.jp

Public contact
Name of contact person	1st name Anna Middle name Last name Tozawa
Organization	ADVANTAGE Risk Management Co., Ltd.
Division name	Research Department
Zip code	153-0051
Address	17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
TEL	03-5794-3817
Homepage URL
Email	atozawa@armg.jp

Sponsor
Institute	ADVANTAGE Risk Management Co., Ltd.
Institute
Department

Funding Source
Organization	ADVANTAGE Risk Management Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	ADVANTAGE Risk Management Co., Ltd.
Address	17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
Tel	03-5794-3817
Email	atozawa@armg.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	2021 Year 01 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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2021 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	2021 Year 01 Month 05 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048987

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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