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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

UMIN000042807.

Study name 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)
Methods Study design: cluster‐RCT
Country: Philippines
Participants Healthcare workers
Inclusion criteria: 
a. healthcare workers at the institution (from the WHO definition, healthcare workers here are everyone who works at the facility)
Exclusion criteria:
a. do not wish to participate in this study;
b. currently undergoing treatment for mental illness.
Stated purpose: to assess the mental health problems of healthcare 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)
Interventions Intervention:
Intervention 1: psychological counselling and stress management training (SMT) for 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 assessment is done 6 weeks after the first assessment.
Intervention 2: Psychological First Aid (PFA) and stress management training for the low‐risk group
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. Two to three 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.
Control:
No treatment (the control group will also be assessed 2‐3 weeks after the intervention group and 4‐6 weeks after the intervention group)
Outcomes Participants'outcomes of interest for this review
  1. Mental health symptoms/depression – Patient Health Questionnaire‐9 (PHQ‐9)

  2. Mental health symptoms/anxiety – General Anxiety Disorder‐7 (GAD‐7)


Economic outcomes
Nil
Time points: baseline, post‐intervention (6 weeks after first assessment)
Starting date NA
Contact information NA
Notes Source of funding: Japan Agency for Medical Research and Development (AMED)
Prospective trial registration number: UMIN000042807