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Clinical Trials/ChiCTR2000034959
ChiCTR2000034959Not yet recruitingPhase 1

A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: Hybrid type 1 effectiveness-implementation randomized controlled trial

澳門大學1 site in 1 country106 target enrollmentStarted: July 25, 2020Last updated:

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
106
Locations
1
Primary Endpoint
self-reported depression symptoms

Study Overview

Brief Summary

The main objective of this study is to determine the effectiveness of the Filipino version of the WHO Step-by-Step (SbS-F) program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to evaluate the effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing; and evaluate the SbS-Fs potential for implementation in real-world settings.

Study Design

Study Type
Interventional
Primary Purpose
随机抽样
Masking
None

Eligibility Criteria

Ages
18 to 99 (—)
Sex
All

Inclusion Criteria

  • Male or female overseas Filipino workers (OFWs) will be included if they meet the following criteria:
  • aged 18 or over;
  • understand English and/or Tagalog;
  • holds a valid working visa in Macao;
  • will stay in Macao for at least six months more;
  • have a mobile phone;
  • have internet access;
  • score 10 on the Patient Health Questionnaire (PHQ-9).

Exclusion Criteria

  • OFWs will be excluded from the study if they:
  • have suicidal intent (more than half the days or nearly every day of the previous two weeks) based on item 9 on the PHQ-9;
  • currently or in the last three months received psychological treatment.

Arms & Interventions

Control group

Brief psychoeducation

Experimental

Digital intervention

Outcomes

Primary Outcomes

self-reported depression symptoms

Time Frame: baseline, endline, follow-up

Secondary Outcomes

  • self-reported anxiety symptoms(baseline, endline, follow-up)
  • self-reported wellbeing(baseline, endline, follow-up)

Investigators

Sponsor
澳門大學

Study Sites (1)

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