Feasibility and uptake of a digital mental health intervention for depression among Lebanese and Syrian displaced people in Lebanon: a qualitative study

IntroductionDigital interventions are increasingly regarded as a potential solution for the inaccessibility of mental health treatment across low-and-middle-income settings, especially for common mental disorders. Step-by-Step (SbS) is a digital, guided self-help intervention for depression found effective in two Randomized Controlled Trials (RCTs) in Lebanon. For research implementation and further scale-up, this paper reports the results of a qualitative evaluation of SbS among the Lebanese and others and displaced Syrians in Lebanon.MethodsThirty-four Key Informant Interviews (KIIs) were executed with participants of the RCTs, SbS staff members, and external stakeholders. Questions garnered feedback about the feasibility, acceptability, enabling factors, and barriers to adhering to the research, implementation, and the SbS intervention. A thematic analysis was conducted using NVivo, and key themes, topics, and recommendations, on research methods and the intervention itself, were generated and reported.ResultsResults showed a high level of acceptability of SbS among Lebanese and Syrians and identified sub-groups for whom acceptance or use might be lower, such as older adults and people with limited access to the internet or smartphones. Furthermore, interviews identified the main enabling factors and barriers to adherence related to the research design, content, and delivery approach. Barriers related to feasibility included lengthy assessments as part of the RCTs, and mistrust related to delays in study compensations. Other common challenges were forgetting login credentials, poor internet connection, being busy and competing needs. Enabling factors and best practices included motivating participants to use the intervention through the weekly support provided by helpers, setting an oral contract for commitment, and dividing the compensations into several installments as part of the RCTs. Recommendations regarding sustainability were given.DiscussionThe findings show that overall, SbS is feasible, acceptable, and much needed in Lebanon among the Lebanese and Syrians. This assessment identifies reasons for low adherence to the research and the intervention and presents improvement solutions. Recommendations generated in this paper inform the upscale of SbS and the planning, design, and implementation of future digital interventions in research and service provision settings in the mental health field

Guided digital health intervention for depression in Lebanon: randomised trial

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

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

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

Guided digital health intervention for depression in Lebanon: randomised trial

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

Step-by-Step: a new WHO digital mental health intervention for depression

The World Health Organization is developing a range of interventions, including technology supported interventions, to help address the mental health treatment gap, particularly in low and middle-income countries. One of these, Step-by-Step, is a guided, technology supported, intervention for depression. It provides psychoeducation and training in behavioural activation through an illustrated narrative with additional therapeutic techniques such as stress management (slow breathing), identifying strengths, positive self-talk, increasing social support and relapse prevention. Step-by-Step has been designed so that it can be adapted for use in settings with different cultural contexts and resource availability and to be meaningful in communities affected by adversity. This paper describes the process of developing Step-by-Step and highlights particular design features aimed at increasing feasibility of implementation in a wide variety of settings

Evaluating the Effectiveness of an E-Mental Health Intervention for People Living in Lebanon: Protocol for Two Randomized Controlled Trials

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 ClinicalTrials.gov (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

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

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

Step-by-Step, an E-Mental Health Intervention for Depression:A Mixed Methods Pilot Study From Lebanon

Background: E-mental health is an established mode of delivering treatment for common mental disorders in many high income countries. However, evidence of its effectiveness in lower income countries is lacking. This mixed methods study presents lessons learned and preliminary data on the feasibility of a minimally guided e-mental health intervention in Lebanon. The aim was to pilot test Step-by-Step, a WHO guided e-mental health intervention, and research methods prior to future, controlled testing. Methods: Participants were recruited using social media and advertisements in primary care clinics. Participants completed baseline and post-intervention questionnaires on depression symptoms (primary outcome, PHQ-8), anxiety symptoms, well-being, disability and self-perceived problem severity, and a client satisfaction questionnaire. In addition, seven completers, four drop-outs, 11 study staff, and four clinic managers were interviewed with responses thematically analyzed. Website analytics were used to understand participant behavior when using the website. Results: A total of 129 participants signed up via the Step-by-Step website. Seventy-four participants started session 1 after completing pre-test questionnaires and 26 completed both baseline and post-intervention data. Among those who completed post-assessments, depression symptoms improved (PHQ-8 scores (t=5.62, p < 0.001 two-tailed, df = 25). Wilcoxon signed ranks tests showed a significant difference between baseline and post-Step-by-Step scores on all secondary outcome measures. Client satisfaction data was positive. Interview responses suggested that the intervention could be made more appropriate for younger, single people, more motivating, and easier to use. Those who utilized the support element of the intervention were happy with their relationship with the non-specialist support person (e-helper), though some participants would have preferred specialist support. E-helpers would have liked more training on complex cases. Website analytics showed that many users dropped out before intervention start, and that some re-entered screening data having been excluded from the study. Conclusion: Step-by-Step skills and techniques, model of service integration, and its non-specialist support element are acceptable. Though the sample was small and non-controlled and drop-out was high, results suggest that it may be effective in reducing depression and anxiety symptoms and increasing well-being. Lessons learned will inform content revision, the development of an app version of Step-by-Step, and the research methodology of upcoming effectiveness studies