UMIN-CTR Clinical Trial

Public title

Effects of two types of smartphone-based stress management programs on depression and anxiety among hospital nurses in Vietnam: a protocol for three-arm randomized controlled trial

Acronym

Effects of two types of smartphone-based stress management programs on depression and anxiety among hospital nurses in Vietnam: a protocol for three-arm randomized controlled trial

Scientific Title

Effects of two types of smartphone-based stress management programs on depression and anxiety among hospital nurses in Vietnam: a protocol for three-arm randomized controlled trial

Scientific Title:Acronym

Effects of two types of smartphone-based stress management programs on depression and anxiety among hospital nurses in Vietnam: a protocol for three-arm randomized controlled trial

Region

Asia(except Japan)

Condition

Depressive and anxiety symptoms

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of newly developed smartphone-based Internet cognitive behavioral therapy (iCBT) programs on preventing depressive and anxiety symptoms as primary outcomes at 3- and 7-month follow-ups among hospital nurses in Vietnam.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Severity of depression and anxiety (assessed by using the Depression Anxiety and Stress Scales [DASS])

Key secondary outcomes

1) Work engagement (assessed by using the Utrecht Work Engagement Scale [UWES])
2) Sickness absence (absenteeism) and reduced job performance (presenteeism) (assessed by using the WHO Health and Productivity Questionnaire [HPQ])
3) Severity of stress symptoms (assessed by using the Depression Anxiety and Stress Scales [DASS])
4) Psychosocial work environment (assessed by using the Job Content Questionnaire [JCQ])
5) Health-related quality of life (assessed by using the EQ-5D-5L)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

A free-choice, smartphone-based multi-module stress management program in which respondents are allowed to select one module per week based on their preference (Program A). Program A includes 6 modules that provide six evidence-based stress management skills (i.e., behavioral activation (Module 1), cognitive restructuring (Module 2), problem-solving (Module 3), assertiveness (Module 4), self-compassion (Module 5), and job crafting (Module 6)).

Interventions/Control_2

A fixed-order, smartphone-based multi-module stress management program in which respondents are required to study modules in a fixed order one per week (Program B). Program B includes 6 modules that provides CBT-based stress management skills (i.e., transactional model of stress and coping (Module 1), self-case formulation based on cognitive behavioral model (Module 2), behavioral activation skills (Module 3), cognitive restructuring skills (Modules 4 and 5), problem-solving skills (Module 6) and relaxation skills (Module 5))

Interventions/Control_3

Waitlist control condition

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Currently employed full-time as registered nurse.
2) Can access the internet via a mobile device such as a smartphone.

Key exclusion criteria

1) Plan to change or quit the job in the next 6 months.
2) Assistant nurses and helpers.
3) Non-regular or part-time employed.
4) Sick leave for 15 or more days for a physical or mental condition in the past 3 months.
5) Current treatment for a mental health problem from a mental health professional.

Target sample size

1080

Name of lead principal investigator

1st name	Norito
Middle name
Last name	Kawakami

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

1130033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-3364

Email

nkawakami@m.u-tokyo.ac.jp

Name of contact person

1st name	Kotaro
Middle name
Last name	Imamura

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

1130033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-3612

Homepage URL

Email

kouima-tky@umin.ac.jp

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

07

Month

01

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037796

Publication of results

Published

URL related to results and publications

https://www.nature.com/articles/s41598-021-90320-5

Number of participants that the trial has enrolled

951

Results

Program B (a fixed-order, internet cognitive behavioral therapy, iCBT) showed a statistically significant effect on improving depressive symptoms at 3-month (p = 0.048), but not at 7-month (p = 0.92); Cohen's d was -0.18 (95% CI: -0.34 to -0.02) and 0.03 (95% CI: -1.00 to 1.05), respectively.

Results date posted

2022

Year

02

Month

14

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

In the whole sample, most participants were females, married, received vocational school or university education, and did not report having chronic diseases. Among the three groups, demographic characteristics of participants were similar. About 24% of participants in each of the three groups had mild depressive symptoms (i.e., scored 10 or more on DASS depression subscale).

Participant flow

Recruitment and the baseline survey were conducted in September 2018. The intervention and control groups were assessed at approximately 3 months (January 2019) and 7 months (May 2019) after the baseline survey. In total, 75.8% of workers (962/1,269) participated in the baseline survey. Out of those workers, 11 were excluded based on exclusion criteria. 951 met the eligibility criteria of this study and were randomly allocated to each of the three groups (two intervention and one control groups) with 317 in each group. After the random assignment, one participant in the intervention group (Program B) and one in the control group were excluded because of duplicate registration.

Adverse events

Regarding the question about adverse events or unintended harm, 250 (78.9%) in the Program A group and 257 (81.3%) in the Program B group answered the question at 7-month follow-up. Out of those, 239 (95.6%) in the Program A group and 253 (98.4%) in the Program B group responded "No."

Outcome measures

Primary outcomes: Depression and anxiety were assessed by using the depression and anxiety subscales of the short 21-item version of the Depression Anxiety and Stress Scales (DASS 21, seven items in each subscale).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

07

Month

01

Day

Date of IRB

2018

Year

06

Month

25

Day

Anticipated trial start date

2018

Year

08

Month

01

Day

Last follow-up date

2019

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

06

Month

25

Day

Last modified on

2022

Year

02

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037796