UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042912 |
|---|---|
| Receipt number | R000048987 |
| Scientific Title | Group video conference program based on acceptance and commitment therapy for young employee: A pre-post trial |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2025/07/11 16:02:03 |
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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
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
atozawa@armg.jp
Sponsor or person
Institute
ADVANTAGE Risk Management Co., Ltd.
Institute
Department
Personal name
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
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
https:// osf.io/z8ghb
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1539/eohp.2024-0015-FS
Number of participants that the trial has enrolled
14
Results
The hypothesis was not supported by any indicator: the primary outcome of well-being; the secondary outcomes of work performance, work engagement, and stress reaction; and the process outcome of psychological inflexibility.
Results date posted
| 2025 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study invited 24 employees in Company A within 3 years after university graduation or postgraduate studies, who are typically aged in their mid-20s. Company A belongs to the service sector and focuses on providing mental health care services to companies in Japan. Demographic characteristics, such as the sex and age of participants, were not obtained to prevent the identification of individuals.
Participant flow
The program was one of the corporate training programs that the president of Company A tasked the human resources department to plan to train young employees in self-care skills to improve mental health. Therefore, no formal sample size calculation was used. All 24 employees who were targeted for training participated in the program. The inclusion criteria were as follows: participants who agreed to participate at time 1, successfully completed each questionnaire, and participated in all three sessions. No exclusion criteria were established.
Well-being and psychological inflexibility
Fourteen participants met the inclusion criteria. Furthermore, referring to Green et al.(2020), they were required to have responded to at least four time points during the baseline (times 1 to 5) and intervention (times 6 to 10) phases, respectively. The sample for final analysis comprised 10 employees that identified as sales (n = 3), clerical (n = 4), planning clerical (n = 1), and professional workers (n = 2).
Work performance, work engagement, and stress reaction
Out of the 14 participants, only those who responded at least two time points from times 1, 7, and 10 were included in the analysis. The sample comprised 13　employees that identified as sales (n = 3), clerical (n = 5), planning clerical (n = 2), professional workers (n = 2), and others (n = 1).
Adverse events
None
Outcome measures
A hierarchical Bayesian model indicated that the hypotheses were not supported in terms of the primary outcome of well being and process outcome of psychological inflexibility of 10 employees because the credible interval included 0 (well-being: expected a posteriori estimation [EAP] 0.22; 95% credible interval, -0.31 to 0.81; Acceptance and Action Questionnaire-II: EAP -2.20; 95% credible interval, -5.60 to 1.31). Tau-U for well-being varied from -0.56 to 0.84 among the participants. Similarly, for the secondary outcomes of 13 employees, the hypotheses were not supported for work performance, work engagement, and stress reaction (World Health Organization Health and Work Performance Questionnaire: EAP -0.32; 95% credible interval, -1.22 to 0.57; Utrecht Work Engagement Scale-3: EAP -0.08; 95% credible interval, -0.47 to 0.34; stress reaction: EAP -0.49; 95% credible interval, -3.76 to 2.66).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | 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
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048987
