Guided digital health intervention for depression in Lebanon: randomised trial.

ABSTRACT

BACKGROUND: Most people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access is adequate, and can be safely delivered during the COVID-19 pandemic. OBJECTIVE: To examine the effects of a new WHO-guided digital mental health intervention, Step-by-Step, supported by a non-specialist helper in Lebanon, in the context of concurring economic, humanitarian and political crises, a large industrial disaster and the COVID-19 pandemic. METHODS: We conducted a single-blind, two-arm pragmatic randomised trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among people suffering from depression and impaired functioning. Primary outcomes were depression (Patient Health Questionnaire 9 (PHQ-9)) and impaired functioning (WHO Disability Assessment Schedule-12 (WHODAS)) at post-treatment. FINDINGS: 680 people with depression (PHQ-9>10) and impaired functioning (WHODAS>16) were randomised to Step-by-Step or ECAU. Intention-to-treat analyses showed effects on depression (standardised mean differences, SMD 0.71; 95% CI 0.45 to 0.97), impaired functioning (SMD 0.43; 95% CI 0.21 to 0.65), post-traumatic stress (SMD 0.53; 95% CI 0.27 to 0.79), anxiety (SMD 0.74; 95% CI 0.49 to 0.99), subjective well-being (SMD 0.37; 95% CI 0.12 to 0.62) and self-identified personal problems (SMD 0.56; 95% CI 0.29 to 0.83). Significant effects on all outcomes were retained at 3-month follow-up. CONCLUSIONS: Guided digital mental health interventions can be effective in the treatment of depression in communities exposed to adversities in LMICs, although some uncertainty remains because of high attrition. CLINICAL IMPLICATIONS Guided digital mental health interventions should be considered for implementation in LMICs. TRIAL REGISTRATION NUMBER ClinicalTrials.gov NCT03720769.