UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042807 |
|---|---|
| Receipt number | R000048854 |
| Scientific Title | Developing an Adaptive Intervention for the Mental Health and Psychosocial Support of Health Workers in the Philippines under COVID-19 Pandemic using the Sequential, Multiple Assignment, Randomized Trial (SMART) |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2020/12/22 09:41:06 |
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Basic information
Public title
Developing an Adaptive Intervention for the Mental Health and Psychosocial Support of Health Workers in the Philippines under COVID-19 Pandemic using the Sequential, Multiple Assignment, Randomized Trial (SMART)
Acronym
Development of mental health support for COVID-19 healthcare professionals in the Philippines
Scientific Title
Developing an Adaptive Intervention for the Mental Health and Psychosocial Support of Health Workers in the Philippines under COVID-19 Pandemic using the Sequential, Multiple Assignment, Randomized Trial (SMART)
Scientific Title:Acronym
Development of mental health support for COVID-19 healthcare professionals in the Philippines
Region
| Asia(except Japan) |
Condition
Condition
Depression and anxiety
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the mental health problems of health care workers responding to the COVID-19 pandemic in the Philippines and to explore suitable online mental health and psychosocial support using Sequential Multiple Assignment Randomized Trial (SMART).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depression: Patient Health Questionnaire 9(PHQ-9)
Anxiety: General Anxiety Disorder Scale (GAD-7)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Psychological counseling and stress management training are provided to the high-risk group.
In the first intervention phase, participants are randomly assigned to either two PCs or a combination of two PCs and STM. This initial intervention phase lasts 2-3 weeks, after which a second assessment is conducted. Those who respond will have completed the treatment. Those who do not respond will be randomly assigned to receive either two additional PC sessions or two additional sessions of PC combined with STM. The third evaluation will take place six weeks after the first one.
Interventions/Control_2
Psychological First Aid and stress management training will be given to the low-risk group. A control group will be established.
In the first intervention phase, participants will be randomized into three groups: the first group will receive PFA, the second group will receive SMT, and the third group will be the control. 2-3 weeks later, a second assessment will be conducted, Those who respond will have completed the treatment; those who do not respond to both PFA and SMT will be randomly assigned to receive the treatment they did not receive or a combination of both for 2-3 weeks. The third assessment is done 6 weeks after the first assessment. The control group will also be assessed 2-3 weeks after the intervention group and 4-6 weeks after the intervention group.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Health care workers at the institution. (From the WHO definition, healthcare workers here are everyone who works at the facility.
Key exclusion criteria
1) Those who do not wish to participate in this study.
(2) Those who are currently undergoing treatment for mental illness.
Target sample size
373
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Oshitani |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Virology
Zip code
980-8575
Address
2-1 Seiryou-machi, Aoba-ku, Sendai-shi, Miyagi 980-8575 Japan
TEL
022-717-8213
oshitanih@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Shinozaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Virology
Zip code
980-8575
Address
2-1 Seiryou-machi, Aoba-ku, Sendai-shi, Miyagi 980-8575 Japan
TEL
022-717-8213
Homepage URL
yasuko.shinozaki.a1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2020 | Year | 12 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 05 | 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
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2020 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048854
