BACKGROUND
The lack of availability of evidence-based services for people exposed to adversity globally has led to the development of psychological interventions with features that will likely make them more scalable. The evidence for the efficacy of e-mental health from high-income countries is compelling and the use of these interventions could be a way to increase the coverage of evidence--based psychological interventions in low- and middle-income countries. Step-by-Step, is a brief (5 session) intervention proposed by WHO as an innovative approach to reducing the suffering and disability associated with depression.
OBJECTIVE
This study aims to evaluate the effectiveness and cost-effectiveness of a locally adapted version of Step-by-Step with Syrian nationals (trial 1) and Lebanese nationals and other populations residing in Lebanon (trial 2).
METHODS
This Step-by-Step trial involves two parallel, two-armed randomized controlled trials (RCTs) comparing the e-intervention Step-by-Step to enhanced care as usual (ECAU) in participants with depressive symptoms and impaired functioning. The RCTs are designed and powered to detect effectiveness in two populations: Syrians in Lebanon (n=568) and other people residing in Lebanon (n=568) (Lebanese nationals and other populations resident in Lebanon). The primary outcomes are depressive symptomatology (measured by the Patient Health Questionnaire [PHQ-9]) and functioning (measured by the WHODAS 2.0). Secondary outcomes include anxiety symptoms, posttraumatic stress disorder (PTSD) symptoms, personalized measures of psychosocial problems, subjective wellbeing and economic effectiveness. Participants are mainly recruited through online advertising. Additional outreach methods will be used if required, for example through dissemination of information through partner agencies and organizations. They can access the intervention on a computer, tablet and mobile phone through a hybrid app. Step-by-Step has 5-sessions and users are guided by trained non-specialist “e-helpers” providing phone or message-based support for around 15 minutes a week.
RESULTS
The trials were funded in 2018. The study protocol was last verified 20.06.2019 (WHO ERC.0002797) and registered with ClinicalTrials.gov (NCT03720769). The trials started recruitment as of December 9th, 2019 and all data collection will likely be completed by November 2020.
CONCLUSIONS
The Step-by-Step trials will provide evidence about the effectiveness of an E-mental health intervention in Lebanon. If the intervention proves to be effective, this will inform future scale up of this and similar interventions in Lebanon and in other settings across the world.
CLINICALTRIAL
NCT03720769