Cost-Effectiveness of Digital Mental Health Versus Usual Care During Humanitarian Crises in Lebanon: Pragmatic Randomized Trial.

BACKGROUND: There is evidence from meta-analyses and systematic reviews that digital mental health interventions for depression, anxiety, and stress-related disorders tend to be cost-effective. However, no such evidence exists for guided digital mental health care in low and middle-income countries (LMICs) facing humanitarian crises, where the needs are highest. Step-by-Step (SbS), a digital mental health intervention for depression, anxiety, and stress-related disorders, proved to be effective for Lebanese citizens and war-affected Syrians residing in Lebanon. Assessing the cost-effectiveness of SbS is crucial because Lebanon's overstretched health care system must prioritize cost-effective treatment options in the face of continuing humanitarian and economic crises. OBJECTIVE: This study aims to assess the cost-effectiveness of SbS in a randomized comparison with enhanced usual care (EUC). METHODS: The cost-effectiveness analysis was conducted alongside a pragmatic randomized controlled trial in 2 parallel groups comparing SbS (n=614) with EUC (n=635). The primary outcome was cost (in US $ for the reference year 2019) per treatment response of depressive symptoms, defined as >50% reduction of depressive symptoms measured using the Patient Health Questionnaire (PHQ). The secondary outcome was cost per remission of depressive symptoms, defined as a PHQ score <5 at last follow-up (5 months post baseline). The evaluation was conducted first from the health care perspective then from the societal perspective. RESULTS: Taking the health care perspective, SbS had an 80% probability to be regarded as cost-effective compared with EUC when there is a willingness to pay US $220 per additional treatment response or US $840 per additional remission. Taking the wider societal perspective, SbS had a >75% probability to be cost-saving while gaining response or remission. CONCLUSIONS: To our knowledge, this study is the first cost-effectiveness analysis based on a large randomized controlled trial (n=1249) of a guided digital mental health intervention in an LMIC. From the principal findings, 2 implications flowed, from the (1) health care perspective and (2) wider societal perspective. First, our findings suggest that SbS is associated with greater health benefits, albeit for higher costs than EUC. It is up to decision makers in health care to decide if they find the balance between additional health gains and additional health care costs acceptable. Second, as seen from the wider societal perspective, there is a substantial likelihood that SbS is not costing more than EUC but is associated with cost-savings as SBS participants become more productive, thus offsetting their health care costs. This finding may suggest to policy makers that it is in the interest of both population health and the wider Lebanese economy to implement SbS on a wide scale. In brief, SbS may offer a scalable, potentially cost-saving response to humanitarian emergencies in an LMIC. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720769; https://clinicaltrials.gov/ct2/show/NCT03720769. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/21585.

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

Introduction: Digital 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. Methods: Thirty-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. Results: Results 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. Discussion: The 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.

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.

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720769; https://clinicaltrials.gov/ct2/show/NCT03720769. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21585.

Reporting Cultural Adaptation in Psychological Trials - The RECAPT criteria.

Background: There is a lack of empirical evidence on the level of cultural adaptation required for psychological interventions developed in Western, Educated, Industrialized, Rich, and Democratic (WEIRD) societies to be effective for the treatment of common mental disorders among culturally and ethnically diverse groups. This lack of evidence is partly due to insufficient documentation of cultural adaptation in psychological trials. Standardised documentation is needed in order to enhance empirical and meta-analytic evidence. Process: A "Task force for cultural adaptation of mental health interventions for refugees" was established to harmonise and document the cultural adaptation process across several randomised controlled trials testing psychological interventions for mental health among refugee populations in Germany. Based on the collected experiences, a sub-group of the task force developed the reporting criteria presented in this paper. Thereafter, an online survey with international experts in cultural adaptation of psychological interventions was conducted, including two rounds of feedback. Results: The consolidation process resulted in eleven reporting criteria to guide and document the process of cultural adaptation of psychological interventions in clinical trials. A template for documenting this process is provided. The eleven criteria are structured along A) Set-up; B) Formative research methods; C) Intervention adaptation; D) Measuring outcomes and implementation. Conclusions: Reporting on cultural adaptation more consistently in future psychological trials will hopefully improve the quality of evidence and contribute to examining the effect of cultural adaptation on treatment efficacy, feasibility, and acceptability.

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.

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.

Upscaling the recruitment and retention of human resources for health at primary healthcare centres in Lebanon: a qualitative study.

The sustainability of primary healthcare (PHC) worldwide has been challenged by a global shortage in human resources for health (HRH). This study is a unique attempt at systematically soliciting and synthesising the voice of PHC and community stakeholders on the HRH recruitment and retention strategies at the PHC sector in Lebanon, the obstacles and challenges hindering their optimisation and the recommendations to overcome such obstacles. A qualitative design was utilised, involving 22 semi-structured interviews with PHC experts in Lebanon conducted in 2013. Nvivo qualitative data analysis software was employed for the thematic analysis of data collected from interviews. Five comprehensive themes emerged: understanding PHC scope, HRH recruitment issues, HRH retention challenges, rural areas' specific challenges and stakeholders' recommendations. Analysis of stakeholders' responses revealed a lack of a unified understanding of the PHC scope impacting the capacity for appropriate HRH planning. Identified impediments to recruitment included the suboptimal supply of HRH, financial constraints and poor management. Retention difficulties were attributed to poor working environments, financial constraints and lack of professional development. There was consensus that HRH challenges faced were aggravated in rural areas, jeopardising the equitable access to PHC services of quality. Equitable access was also jeopardised by the reported shortage of female HRH in a sociocultural context where many females prefer providers of the same gender. The study sets the path towards upscaling recruitment and retention policies and practices through the endorsement of a nationally acknowledged PHC definition and scope, the sustainable development of the PHC workforce and through the implementation of targeted recruitment and retention strategies addressing rural settings and gender equity. Decision-makers and planners are urged to identify HRH as the most important input for the success of PHC programmes and interventions, especially in the growing fields of mental health and geriatric care.