A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial

Abstract

Background The current pilot randomized controlled trial (RCT) protocol will comprehensively describe the implementation of a culturally adapted Filipino version of the World Health Organization Step-by-Step (SbS-F) program, unguided online psychological intervention for people with depression based on behavioral activation, among overseas Filipino workers (OFWs) in Macao (Special Administrative Region). The main objective of this pilot study is to explore the preliminary effectiveness of the SbS-F program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to explore the preliminary effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing, and to evaluate the potential for SbS-F implementation in real-world settings. Methods This trial will follow an effectiveness-implementation hybrid type 1 trial design and utilize the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to accelerate the translation of clinical research into more effective implementation strategies and policies. Participants will be randomized 1:1 to control and treatment groups. Control group participants will receive ECAU that consists of brief depression psychoeducation and referral to local community partners. Treatment group participants will receive a 5-session of digital intervention through a mobile phone application. The primary outcome (depression) and psychological secondary outcomes (anxiety symptoms and wellbeing) will be measured using validated instruments. To evaluate study implementation, an embedded mixed-methods design will be used to collect data from various stakeholders. Data then will be analyzed using intention to treat principle and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline. Discussion This study will provide important new knowledge about the preliminary effectiveness of SbS-F, a mobile application, as a digital mental health intervention and its scalability. If SbS-F shows positive results among OFWs in Macao, it has strong potential to be used by OFWs in other countries that may also experience depression and difficulty accessing mental health services. Trial registration Prospective registration, Chinese Clinical Trial Registry (ChiCTR2000034959) on 26/07/2020.

Strategies for Implementing Occupational eMental Health Interventions: Scoping Review

“…Most (25/31, 81%) [ 8 , 36 - 47 , 49 - 59 ] of the included articles were published between 2015 and 2021 and were mainly primary studies (23/31, 74%) [ 36 , 39 , 41 - 51 , 53 , 54 , 56 - 58 , 60 - 63 , 65 ]. Of the 31 included publications on OeMH interventions, 14 (45%) focused on their implementation [ 8 , 37 , 38 , 40 , 41 , 49 - 51 , 53 , 54 , 62 - 64 ] and 17 (55%) did not focus on their implementation but had results or noted implications related to their implementation [ 36 , 39 , 42 - 47 , 52 , 55 - 61 , 65 ].…”

“…A total of 24 interventions were reported in 27 studies [ 36 - 46 , 49 , 51 - 56 , 58 - 65 ] ( Table 3 ). These interventions were largely web-based (n=16, 67%%) [ 41 - 46 , 48 , 49 , 51 , 53 - 55 , 60 - 65 ] and most aimed to improve (n=19, 79%) [ 36 , 37 , 40 , 42 - 46 , 49 , 51 - 56 , 58 - 63 ] and, to a lesser extent, educate users about mental health problems. Most interventions have focused on stress-related disorders and symptoms (n=17, 71%) [ 8 , 36 - 47 , 49 - 51 , 53 - 63 , 65 ], but a wide range of mental health problems (eg, burnout, anxiety disorders, and substance-related disorders) have also been covered to some extent.…”

“…Strategies to improve the effectiveness of the intervention mainly relied on insights obtained from a diverse group of professionals in relevant fields, representatives of implementation sites, target users, and intervention use data (12/19, 63%). This insight was captured through stakeholder consultations [ 41 ], steering group interviews and focus groups with target users [ 36 ], peer review panels [ 41 ], and user experience research [ 36 , 37 , 41 , 52 , 53 , 63 ] throughout the implementation process. Several strategies adopted an incremental approach to implementation [ 52 , 55 , 59 ] (3/19, 16%), fostered adaptability in the intervention to adequately meet the local needs [ 60 ] (2/19, 11%), or implemented measures to avoid or mitigate identified barriers that could negatively impact the effectiveness of the particular intervention [ 49 , 52 ] (2/19, 11%).…”

“…Embedding interventions within existing employee programs was also expected to help sustain the use of the intervention [ 58 ] (1/8, 13%). Special monitoring measures (eg, postintervention acceptability surveys and opportunities for monthly user feedback) were also established to provide insight into how benefits to users could be sustained after the initiative had officially ended [ 37 , 64 ] (2/8, 25%).…”

Evaluating the Implementation of a Mental Health App for Overseas Filipino Workers in Macao China: A Mixed-Methods Study of Stakeholders’ Perspectives

“…This implementation science evaluation study used a mixed-methods parallel convergent design ( 27 ). The evaluation was conducted in two parallel steps, using quantitative and qualitative measures, which complemented each other and provided more comprehensive evaluation results ( 28 ).…”