UMIN-CTR Clinical Trial

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
Email	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
Email	yasuko.shinozaki.a1@tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048854