Step-by-step: Feasibility randomised controlled trial of a mobile-based intervention for depression among populations affected by adversity in Lebanon

Abstract

Background E-mental health interventions may help to bridge the mental health treatment gap. Evidence on their effectiveness is compelling in high-income countries. Not enough evidence has been generated on their use with communities affected by adversity in low- and middle-income countries. The World Health Organization (WHO), the National Mental Health Programme (NMMP) at Ministry of Public Health (MoPH) in Lebanon and other partners have adapted a WHO intervention called Step-by-Step for use with Lebanese and displaced people living in Lebanon. Step-by-Step is a minimally guided, internet-based intervention for adults with depression. In this study, a feasibility randomised controlled trial (RCT) and a qualitative process evaluation were conducted to explore the feasibility and the acceptability of the research methods, and the intervention, in preparation for two fully powered trials to assess the effectiveness and cost-effectiveness of Step-by-Step in Lebanon. Method Participants were recruited through social media. Inclusion criteria were: being able to understand and speak Arabic or English; access to an internet connected device; aged over 18; living in Lebanon; scores above cut-off on the Patient Health Questionnaire and the WHO Disability Assessment Schedule 2.0. Participants were randomly assigned to the intervention or enhanced care as usual. They completed post-assessments eight weeks after baseline, and follow-up assessments another three months later. Primary outcomes were depression and level of functioning, secondary outcomes were anxiety, post-traumatic stress, and well-being. Qualitative interviews were conducted to evaluate the feasibility and acceptability of the research procedures and the intervention. Results A total of N = 138 participants, including 33 Syrians, were recruited and randomised into two equal groups. The dropout rate was higher in the control group (73% post- and 82% follow-up assessment) than in the intervention group (63% post- and 72% follow-up assessment). The intervention was perceived as relevant, acceptable and beneficial to those who completed it. Suggestions were made to further adapt the content and to make the intervention more engaging. Statistical analyses were conducted despite the small sample size. Complete cases analysis showed a statistically significant symptom reduction in depression, anxiety, disability, and post-traumatic stress, and statistically significant improvement in well-being and functioning. Intention-to-treat analysis revealed non-significant effects. Conclusion The research design, methods and procedures are feasible and acceptable in the context of Lebanon and can be applied in the RCTs. Preliminary findings suggest that Step-by-Step may be effective in reducing symptoms of depression and anxiety and improving functioning and well-being.

A Feasibility Study of the WHO Digital Mental Health Intervention Step-by-Step to Address Depression Among Chinese Young Adults

“…The full program completion rate (completed all sessions) in this study was 37.5% (n = 9) among intervention starters, which was similar to Harper Shehadeh et al (41) and Heim et al (20), 43.2 and 32.8%, respectively. Completion rates (proportion of eligible participants who completed at least three therapeutic sessions in this study were comparable to other SbS studies, with 54.2% in the current study and 62.2% in (41) and 35.9 % in Heim et al (20). The preliminary results showed that full completers showed the greatest improvement, and minimal difference in improvement between full completers (completed all sessions) and partial completers (completed 3-4 sessions) was observed (see Table 4), suggesting the treatment gains between the two groups of completers are comparable.…”

“…Due to the comparable participation rate with previous literature, we suggested that the Chinese SbS was feasible. Compared with Heim et al (20) and Harper Shehadeh et al (41), the non-starting rate (did not start any session) was 36.8% in this current study, which was lower than in other SbS studies (42.6 and 69.2%). Overall dropout rate (completed <4 therapeutic sessions) among those who started the intervention (n = 24) was 45.8% at post-assessment in this study, which was similar to other SbS studies at approximately 50%.…”

“…These features were also universally mentioned and greatly accepted by the participants in the qualitative interview. Consistent with other adapted versions of the Step-by-Step program, the Chinese version showed preliminary evidence of significant improvement in depressive and anxiety symptoms, and client-defined stress (20,41). Future studies that specifically target users who are seeking mental health support may yield greater completion rates.…”

“…Paired sample t-tests were performed to obtain within-group change in study outcomes from baseline to post-test assessment. For the purpose of our analyses and comparison with previous studies (20,41), we considered completers to be anyone who at least partially completed session 0 and 3 additional sessions, starters to be anyone who at least partially completed session 0 and completed 1-2 additional sessions, and non-starters to be anyone who completed none of the interventional sessions (i.e., session 1-5). Both starters and non-starters who completed session 0 were considered as dropouts.…”

“…Germany, the WHO developed the web version of Step-by-Step (SbS) (17), which was later developed into a mobile app and culturally adapted for a diversity of populations (18)(19)(20)(21)(22)(23). In order to evaluate the effectiveness and implementation of SbS in a Chinese tertiary educational setting, SbS was culturally adapted (23), followed by the current feasibility study that preliminarily tested the adapted intervention, and informed the study process of a future randomized controlled trial (RCT), which is now planned (24), guided by the developmentevaluation-implementation process (25) and implementation evaluation framework (26,27).…”