Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial

Abstract

Background Most displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon. Methods and findings We conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate. Conclusions In this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access. Trial registration ClinicalTrials.gov NCT03720769.

Implementing Arabic-language digital interventions for depression in German routine health care: log data analysis of the iFightDepression (iFD) tool and awareness website

“…The DID were evidence-informed, but have not been assessed for efficacy in their Arabic language and culturally adapted versions. There is, however, strong evidence for the efficacy of similar DID in Arabic language 24 and for the iFD tool itself 33 including an assessment of possible negative effects 43 . Patients and ASR representatives were not part of the expert group guiding the translation and adaptation process.…”

“…On the one hand there are successful examples of routine care implementations 21 , on the other hand intervention adoption seems to stay below expectations and usage behavior may vary from that reported in controlled trials 22 . And while the DID for ASR seem to be well accepted in trial settings [23][24][25] , their implementation into routine health and social care has not yet been systematically studied.…”

Smartphone-delivered mental health care interventions for refugees: A systematic review of the literature

“…Step-by-Step and Problem Management Plus are currently investigated in RCTs thus providing results on this question in the future (cf., Goodman et al, 2021). Recently published data on guided versions are promising (Cuijpers et al, 2022).…”

“…Although we could not find this effect clearly in the studies included, different scalable interventions for refugees from the World Health Organization (WHO) like Step-by-Step and Problem Management Plus are currently investigated in RCTs thus providing results on this question in the future (cf., Goodman et al, 2021 ). Recently published data on guided versions are promising (Cuijpers et al, 2022 ).…”

“…Furthermore, since the field of study is constantly growing, new evidence is published frequently. For instance, new evidence on the intervention Step-by-Step and Sanadak has recently been published and could not be included in the systematic review (Böge et al, 2022 ; Cuijpers et al, 2022 ). Third, based on the current state of research, we were unable to look more closely at subgroups of refugees, for example, according to language, home country, or resettlement country.…”