Unique ID issued by UMIN | UMIN000044145 |
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Receipt number | R000050128 |
Scientific Title | A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand |
Date of disclosure of the study information | 2021/05/31 |
Last modified on | 2022/08/17 12:33:34 |
A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand
A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand
A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand
A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand
Japan | Asia(except Japan) |
Depressive symptoms
Adult |
Others
NO
The objective of the present RCT is to investigate the effect of an internet based- Cognitive Behavioral Therapy (iCBT) stress management program on depression and other mental health-related outcomes of nurses in Vietnam and Thailand in the with/post COVID-19 epidemic period.
Efficacy
Depression (DASS21) (Henry et al., 2005)
1. Fear of COVID-19 (Fear of COVID-19 Scale) (Ahorsu et al, 2020)
2. Psychological distress (Kessler 6 (K6)) (Kessler et al., 2002)
3. Anxiety and stress/ (DASS21) (Henry et al., 2005)
4. Work engagement (UWES) (Schaufeli et al, 2002)
5. Health-related QOL (EQ-5D-5L) (Herdman et al., 2011)
6. Sick leave days and work performance (adopted from WHO-HPQ) (Kessler et al., 2003)
7. Intention to leave (intention to leave the profession; intention to leave the organization) (Hasselhorn et al., 2005)
8. Quality of nursing care (self-reported) (Aiken et al., 2002)
9. Copenhagen Burnout Inventory (CBI) (Kristensen et al., 2005)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is considered as a block.
YES
Central registration
2
Prevention
Behavior,custom |
The intervention program is an Internet-based stress management program accessible from smartphone, tablets, and PCs, developed targeting nurses in Vietnam and Thailand in the with/post-COVID-19 period, based on a previous program that successfully improved positive emotions of nurses in Vietnam (Sasaki et al., 2021), with appropriate modifications.
The program includes seven modules. These modules provide cognitive-behavioral stress management skills, and will be available one by one per week in a fixed order from module 1 to module 7. The topic of each module is as follows: a transactional model of stress and coping (module 1), self-case formulation based on cognitive behavioral model (module 2), behavioral activation (module 3), cognitive restructuring (module 4), cognitive restructuring and relaxation (module 5), problem-solving (module 6), and stress coping in the COVID-19 epidemic (module 7).
Participants will be allowed to study the program for 10 weeks from the beginning.
The control group receives no treatment (TAU).
Not applicable |
Not applicable |
Male and Female
(1) Currently employed full time as a registered nurse in Vietnam or Thailand
(2) Can access the internet via a mobile device such as a smartphone
(1) Those who are on sick leave or maternity leave at baseline or plan to leave/change the job or take maternity leave in the next 6 months
(2) Assistant nurses and helpers
(3) Non-regular or part-time employed
(4) Sick leave for 10 or more days for a physical or mental condition in the past 4 weeks.
(5) Currently receiving treatment for a mental health problem from any health care professional.
1500
1st name | Norito |
Middle name | |
Last name | Kawakami |
The University of Tokyo
Department of Mental Health
113-0033
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
0358413364
norito@m.u-tokyo.ac.jp
1st name | Norito |
Middle name | |
Last name | Kawakami |
The University of Tokyo
Department of Mental Health
113-0033
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
0358413364
norito@m.u-tokyo.ac.jp
The University of Tokyo
The Grants-in-Aid for Scientific Research (KAKENHI)
Japanese Governmental office
Japan
Hanoi University of Public Health, Vietnam
Mahidol University Faculty of Public Health, Thailand
Office for Human Research Studies (OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
0358410818
ethics@m.u-tokyo.ac.jp
NO
2021 | Year | 05 | Month | 31 | Day |
Unpublished
No longer recruiting
2021 | Year | 05 | Month | 31 | Day |
2021 | Year | 06 | Month | 23 | Day |
2022 | Year | 02 | Month | 28 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 05 | Month | 31 | Day |
2021 | Year | 05 | Month | 08 | Day |
2022 | Year | 08 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050128
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