UMIN-CTR Clinical Trial

Basic information
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
Condition	Depressive and anxiety symptoms
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
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
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	2018 Year 07 Month 01 Day

Related information
URL releasing protocol	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037796
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2018 Year 06 Month 25 Day
Last modified on	2022 Year 02 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037796