UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044145
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

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Basic information

Public title

A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand

Acronym

A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand

Scientific Title

A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand

Scientific Title:Acronym

A randomized controlled trial of the effect of an Internet cognitive behavioral therapy e-learning program for nurses in Vietnam and Thailand

Region

Japan Asia(except Japan)


Condition

Condition

Depressive symptoms

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Depression (DASS21) (Henry et al., 2005)

Key secondary outcomes

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)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

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.

Interventions/Control_2

The control group receives no treatment (TAU).

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(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

Key exclusion criteria

(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.

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name Norito
Middle name
Last name Kawakami

Organization

The University of Tokyo

Division name

Department of Mental Health

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

TEL

0358413364

Email

norito@m.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Norito
Middle name
Last name Kawakami

Organization

The University of Tokyo

Division name

Department of Mental Health

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

TEL

0358413364

Homepage URL


Email

norito@m.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

The Grants-in-Aid for Scientific Research (KAKENHI)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Hanoi University of Public Health, Vietnam
Mahidol University Faculty of Public Health, Thailand

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Office for Human Research Studies (OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

Tel

0358410818

Email

ethics@m.u-tokyo.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

2021 Year 05 Month 31 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

No longer recruiting

Date of protocol fixation

2021 Year 05 Month 31 Day

Date of IRB

2021 Year 06 Month 23 Day

Anticipated trial start date

2022 Year 02 Month 28 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 05 Month 08 Day

Last modified on

2022 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050128


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name