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Internet Interv ; 24: 100380, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33747798


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.

JMIR Res Protoc ; 10(1): e21585, 2021 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-33507158


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 the World Health Organization 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 2 parallel, two-armed, randomized controlled trials comparing the e-intervention Step-by-Step to enhanced care as usual in participants with depressive symptoms and impaired functioning. The randomized controlled trials are designed and powered to detect effectiveness in 2 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 with the Patient Health Questionnaire-9) and functioning (measured with the World Health Organization Disability Assessment Scale 2.0). Secondary outcomes include anxiety symptoms, posttraumatic stress disorder symptoms, personalized measures of psychosocial problems, subjective well-being, 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 nonspecialist "e-helpers" providing phone-based or message-based support for around 15 minutes a week. RESULTS: The trials were funded in 2018. The study protocol was last verified June 20, 2019 (WHO ERC.0002797) and registered with (NCT03720769). The trials started recruitment as of December 9, 2019, and all data collection was completed in December 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. TRIAL REGISTRATION: NCT03720769; INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21585.