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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033139
Receipt No. R000037796
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
Date of disclosure of the study information 2018/07/01
Last modified on 2019/06/26

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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
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
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
2019 Year 06 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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