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.

Experience of primary healthcare workers in using the mobile app-based WHO mhGAP intervention guide in detection and treatment of people with mental disorders: A qualitative study in Nepal.

This study assessed perception and experience of trained primary health care workers in using a mobile app-based version of the WHO mental health gap action programme (mhGAP) Intervention Guide in the assessment and management of people with mental health conditions in primary care in Nepal. A qualitative study was conducted with primary healthcare workers who were trained in using the WHO mhGAP mobile application in Jhapa, a district in eastern Nepal. Semi-structured interviews were carried out with 15 healthcare workers (3 females and 12 males) nine months after the training. Interviews were audio recorded, transcribed and translated into English for the thematic qualitative data analysis. Health care workers (HCWs) found the mobile app helpful to verify and confirm their assessment and diagnosis. The other benefits reported by the participants were: bringing uniformity in diagnosis and management of mental health conditions across primary healthcare facilities; reminding the HCWs specific assessment questions; creating awareness on the importance of psychosocial intervention; improving the interaction between patients and service providers; and the importance of follow-up care. Despite these advantages, lack of clarity about report submission modality; lack of electricity or internet connectivity; and low technology literacy among older HCWs were some of the barriers in using the app. The major recommendation made by the HCWs for the guide included revision of the assessment process and system; inclusion of a chat function with supervisors; minimizing the amount of patients' data to be collected in the app; and addition of conversion and anxiety disorders to the app. This study concludes that the mobile decision support application could be acceptable and feasible in primary care settings if the suggested modifications are incorporated, in addition to addressing other systemic issues facing the primary care-based delivery of mental health services.

Prevention and promotion effects of Self Help Plus: secondary analysis of cluster randomised controlled trial data among South Sudanese refugee women in Uganda.

INTRODUCTION: Evidence-based and scalable prevention and promotion focused mental health and psychosocial support interventions are needed for conflict-affected populations in humanitarian settings. This study retrospectively assessed whether participation in Self Help Plus (SH+) versus enhanced usual care (EUC) resulted in reduced incidence of probable mental disorder and increased positive mental health and well-being post-intervention among South Sudanese refugee women in Uganda. METHODS: This study used secondary data from treatment-oriented pilot (n=50) and fully-powered cluster randomised controlled trials (cRCT)s (n=694) of SH+ versus EUC. Data from baseline and post-intervention assessments were combined. A composite latent indicator for mental health problems was generated using mental health and well-being measures included in both cRCTs. In order to assess incidence, a binary variable approximating probable mental disorder was created to exclude those with probable mental disorder from the analysis sample and as the primary prevention outcome. The promotive effects of SH+ relative to EUC were examined in the same sample by assessing subjective well-being and psychological flexibility scale scores. RESULTS: A single factor for mental health problems was identified with all factor loadings >0.30 and acceptable internal consistency (α=0.70). We excluded 161 women who met criteria for probable mental disorder at baseline. Among those with at least moderate psychological distress but without probable mental disorder at baseline and with follow-up data (n=538), the incidence of probable mental disorder at post-intervention was lower among those who participated in SH+ relative to EUC (Risk ratio =0.16, 95% CI: 0.05 to 0.53). Participation in SH+ versus EUC was also associated with increased subjective well-being (ß=2.62, 95% CI: 1.63 to 3.60) and psychological flexibility (ß=4.55, 95% CI: 2.92 to 6.18) at post-intervention assessment. CONCLUSIONS: These results support the use and further testing of SH+ as a selective and indicated prevention and promotion focused psychosocial intervention in humanitarian settings. TRIAL REGISTRATION NUMBER: ISRCTN50148022.

Self-Help Plus for refugees and asylum seekers: an individual participant data meta-analysis.

QUESTION: Refugees and asylum seekers are at high risk of mental disorders due to various stressors before, during and after forceful displacement. The WHO Self-Help Plus (SH+) intervention was developed to manage psychological distress and a broad range of mental health symptoms in vulnerable populations. This study aimed to examine the effects and moderators of SH+ compared with Enhanced Care as Usual (ECAU) in reducing depressive symptoms among refugees and asylum seekers. STUDY SELECTION AND ANALYSIS: Three randomised trials were identified with 1795 individual participant data (IPD). We performed an IPD meta-analysis to estimate the effects of SH+, primarily on depressive symptoms and second on post-traumatic stress, well-being, self-identified problems and functioning. Effects were also estimated at 5-6 months postrandomisation (midterm). FINDINGS: There was no evidence of a difference between SH+ and ECAU+ in reducing depressive symptoms at postintervention. However, SH+ had significantly larger effects among participants who were not employed (ß=1.60, 95% CI 0.20 to 3.00) and had lower mental well-being levels (ß=0.02, 95% CI 0.001 to 0.05). At midterm, SH+ was significantly more effective than ECAU in improving depressive symptoms (ß=-1.13, 95% CI -1.99 to -0.26), self-identified problems (ß=-1.56, 95% CI -2.54 to -0.59) and well-being (ß=6.22, 95% CI 1.60 to 10.90). CONCLUSIONS: Although SH+ did not differ significantly from ECAU in reducing symptoms of depression at postintervention, it did present benefits for particularly vulnerable participants (ie, unemployed and with lower mental well-being levels), and benefits were also evident at midterm follow-up. These results are promising for the use of SH+ in the management of depressive symptoms and improvement of well-being and self-identified problems among refugees and asylum seekers.

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

[This corrects the article DOI: 10.1371/journal.pmed.1004025.].

Psychological flexibility in South Sudanese female refugees in Uganda as a mechanism for change within a guided self-help intervention.

OBJECTIVE: To examine the role of psychological flexibility as a potential mediator in the relationship between involvement in a guided self-help intervention, Self-Help Plus, and psychological distress in a sample of South Sudanese refugee women living in northern Uganda. METHOD: We conducted secondary analysis of data from a cluster randomized controlled trial conducted in 2018. We used multilevel mediation modeling to explore the relationship of psychological flexibility, as measured by the Acceptance and Action Questionnaire (AAQ-II), as a mediating factor in the relationship between Self-Help Plus involvement and general psychological distress as measured by the Kessler Psychological Distress Scale-6 (K6). RESULTS: We found strong multilevel mediation of decreased K6 scores in the treatment group by AAQ-II scores (multilevel b = -3.28). A more pronounced mediation effect was discovered immediately post intervention (b = -1.09) compared to 3-month follow-up (b = -0.84). This is in line with the current literature that demonstrates the role of psychological flexibility as a primary mechanism of change in ACT-based interventions. CONCLUSIONS: Psychological flexibility is a contributing component in the theory of change for this ACT-based intervention. Identifying the core components of interventions allows for more effective adaptation and implementation of relevant services, especially in low-resource contexts. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Identifying Core Competencies for Remote Delivery of Psychological Interventions: A Rapid Review.

OBJECTIVE: The COVID-19 pandemic led to a rapid shift toward remote delivery of psychological interventions and transition to voice-only and video communication platforms. However, agreement is lacking on key competencies that are aligned with equitable approaches for standardized training and supervision of remote psychological intervention delivery. A rapid review was conducted to identify and describe competencies that could inform best practices of remote services delivery during and after the COVID-19 pandemic. METHODS: Scopus, MEDLINE, and PsycINFO were searched for literature published in English (2015-2021) on competencies for synchronous, remote psychological interventions that can be measured through observation. RESULTS: Of 135 articles identified, 12 met inclusion criteria. Studies targeted populations in high-income countries (11 in the United States and Canada, one in Saudi Arabia) and focused on specialist practitioners, professionals, or trainees in professional or prelicensure programs working with adult populations. Ten skill categories were identified: emergency and safety protocols for remote services, facilitating communication over remote platforms, remote consent procedures, technological literacy, practitioner-client identification for remote services, confidentiality during remote services, communication skills during remote services, engagement and interpersonal skills for remote services, establishing professional boundaries during remote services, and encouraging continuity of care during remote services. CONCLUSIONS: These 10 skills domains can offer a foundation for refinement of discrete, individual-level competencies that can be aligned with global initiatives promoting use of observational competency assessment during training and supervision programs for psychological interventions. More research is needed on identification of and agreement on remote competencies and on their evaluation.

Development and functioning of the mobile app-based mh-GAP intervention guide in detection and treatment of people with mental health conditions in primary healthcare settings in Nepal.

This paper describes the development process of a mobile app-based version of the World Health Organization mental health Gap Action Programme Intervention Guide, testing of the app prototypes, and its functionality in the assessment and management of people with mental health conditions in Nepal. Health workers' perception of feasibility and acceptability of using mobile technology in mental health care was assessed during the inspiration phase (N = 43); the ideation phase involved the creation of prototypes; and prototype testing was conducted over multiple rounds with 15 healthcare providers. The app provides provisional diagnoses and treatment options based on reported symptoms. Participants found the app prototype useful in reminding them of the process of assessment and management of mental disorders. Some challenges were noted, these included a slow app prototype with multiple technical problems, including difficulty in navigating 'yes'/'no' options, and there were challenges reviewing detailed symptoms of a particular disorder using a "more information" icon. The initial feasibility work suggests that if the technical issues are addressed, the e-mhGAP warrants further research to understand if it is a useful method in improving the detection of people with mental health conditions and initiation of evidence-based treatment in primary healthcare facilities.

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.

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.

Cost-effectiveness of the Self-Help Plus Intervention for Adult Syrian Refugees Hosted in Turkey.

Importance: The cost-effectiveness of the Self-Help Plus (SH+) program, a group-based, guided, self-help psychological intervention developed by the World Health Organization for people affected by adversity, is unclear. Objective: To investigate the cost-utility of providing the SH+ intervention combined with enhanced usual care vs enhanced usual care alone for Syrian refugees or asylum seekers hosted in Turkey. Design, Setting, and Participants: This economic evaluation was performed as a prespecified part of an assessor-blinded randomized clinical trial conducted between October 1, 2018, and November 30, 2019, with 6-month follow-up. A total of 627 adults with psychological distress but no diagnosed psychiatric disorder were randomly assigned to the intervention group or the enhanced usual care group. Interventions: The SH+ program was a 5-session (2 hours each), group-based, stress management course in which participants learned self-help skills for managing stress by listening to audio sessions. The SH+ sessions were facilitated by briefly trained, nonspecialist individuals, and an illustrated book was provided to group members. Th intervention group received the SH+ intervention plus enhanced usual care; the control group received only enhanced usual care from the local health care system. Enhanced usual care included access to free health care services provided by primary and secondary institutions plus details on nongovernmental organizations and freely available mental health services, social services, and community networks for people under temporary protection of Turkey and refugees. Main Outcomes and Measures: The primary outcome measure was incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the Turkish health care system. An intention-to-treat analysis was used including all participants who were randomized and for whom baseline data on costs and QALYs were available. Data were analyzed September 30, 2020, to July 30, 2021. Results: Of 627 participants (mean [SD] age, 31.3 [9.0] years; 393 [62.9%] women), 313 were included in the analysis for the SH+ group and 314 in the analysis for the enhanced usual care group. An incremental cost-utility ratio estimate of T£6068 ($1147) per QALY gained was found when the SH+ intervention was provided to groups of 10 Syrian refugees. At a willingness to pay per QALY gained of T£14 831 ($2802), the SH+ intervention had a 97.5% chance of being cost-effective compared with enhanced usual care alone. Conclusions and Relevance: This economic evaluation suggests that implementation of the SH+ intervention compared with enhanced usual care alone for adult Syrian refugees or asylum seekers hosted in Turkey is cost-effective from the perspective of the Turkish health care system when both international and country-specific willingness-to-pay thresholds were applied.

Scalable psychological interventions for Syrian refugees in Europe and the Middle East: STRENGTHS study protocol for a prospective individual participant data meta-analysis.

INTRODUCTION: The World Health Organization's (WHO) scalable psychological interventions, such as Problem Management Plus (PM+) and Step-by-Step (SbS) are designed to be cost-effective non-specialist delivered interventions to reduce symptoms of common mental disorders, such as anxiety, depression and post-traumatic stress disorder (PTSD). The STRENGTHS consortium aims to evaluate the effectiveness, cost-effectiveness and implementation of the individual format of PM+ and its group version (gPM+), as well as of the digital SbS intervention among Syrian refugees in seven countries in Europe and the Middle East. This is a study protocol for a prospective individual participant data (IPD) meta-analysis to evaluate (1) overall effectiveness and cost-effectiveness and (2) treatment moderators of PM+, gPM+ and SbS with Syrian refugees. METHODS AND ANALYSIS: Five pilot randomised controlled trials (RCTs) and seven fully powered RCTs conducted within STRENGTHS will be combined into one IPD meta-analytic dataset. The RCTs include Syrian refugees of 18 years and above with elevated psychological distress (Kessler Psychological Distress Scale (K10>15)) and impaired daily functioning (WHO Disability Assessment Schedule 2.0 (WHODAS 2.0>16)). Participants are randomised into the intervention or care as usual control group, and complete follow-up assessments at 1-week, 3-month and 12-month follow-up. Primary outcomes are symptoms of depression and anxiety (25-item Hopkins Symptom Checklist). Secondary outcomes include daily functioning (WHODAS 2.0), PTSD symptoms (PTSD Checklist for DSM-5) and self-identified problems (PSYCHLOPS). We will conduct a one-stage IPD meta-analysis using linear mixed models. Quality of evidence will be assessed using the GRADE approach, and the economic evaluation approach will be assessed using the CHEC-list. ETHICS AND DISSEMINATION: Local ethical approval has been obtained for each RCT. This IPD meta-analysis does not require ethical approval. The results of this study will be published in international peer-reviewed journals.

Effectiveness of a WHO self-help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial.

Refugees are at high risk of developing mental disorders. There is no evidence from randomized controlled trials (RCTs) that psychological interventions can prevent the onset of mental disorders in this group. We assessed the effectiveness of a self-help psychological intervention developed by the World Health Organization, called Self-Help Plus, in preventing the development of mental disorders among Syrian refugees experiencing psychological distress in Turkey. A two-arm, assessor-masked RCT was conducted in two Turkish areas. Eligible participants were adult Syrian refugees experiencing psychological distress (General Health Questionnaire ≥3), but without a diagnosis of mental disorder. They were randomly assigned either to the Self-Help Plus arm (consisting of Self-Help Plus combined with Enhanced Care as Usual, ECAU) or to ECAU only in a 1:1 ratio. Self-Help Plus was delivered in a group format by two facilitators over five sessions. The primary outcome measure was the presence of any mental disorder assessed by the Mini International Neuropsychiatric Interview at six-month follow-up. Secondary outcome measures were the presence of mental disorders at post-intervention, and psychological distress, symptoms of post-traumatic stress disorder and depression, personally identified psychological outcomes, functional impairment, subjective well-being, and quality of life at post-intervention and six-month follow-up. Between October 1, 2018 and November 30, 2019, 1,186 refugees were assessed for inclusion. Five hundred forty-four people were ineligible, and 642 participants were enrolled and randomly assigned to either Self-Help Plus (N=322) or ECAU (N=320). Self-Help Plus participants were significantly less likely to have any mental disorders at six-month follow-up compared to the ECAU group (21.69% vs. 40.73%; Cramer's V = 0.205, p<0.001, risk ratio: 0.533, 95% CI: 0.408-0.696). Analysis of secondary outcomes suggested that Self-Help Plus was not effective immediately post-intervention, but was associated with beneficial effects at six-month follow-up in terms of symptoms of depression, personally identified psychological outcomes, and quality of life. This is the first prevention RCT ever conducted among refugees experiencing psychological distress but without a mental disorder. Self-Help Plus was found to be an effective strategy for preventing the onset of mental disorders. Based on these findings, this low-intensity self-help psychological intervention could be scaled up as a public health strategy to prevent mental disorders in refugee populations exposed to ongoing adversities.

Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial.

INTRODUCTION: Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress. OBJECTIVE: To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe. METHODS: We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes. RESULTS: Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer V = 0.007, p = 0.90, RR = 0.96; 95% CI 0.52-1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer V = 0.13, p = 0.01, RR = 0.50; 95% CI 0.29-0.87). CONCLUSIONS: This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified.

Adaptation of the World Health Organization Electronic Mental Health Gap Action Programme Intervention Guide App for Mobile Devices in Nepal and Nigeria: Protocol for a Feasibility Cluster Randomized Controlled Trial.

BACKGROUND: There is a growing global need for scalable approaches to training and supervising primary care workers (PCWs) to deliver mental health services. Over the past decade, the World Health Organization Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) and associated training and implementation guidance have been disseminated to more than 100 countries. On the basis of the opportunities provided by mobile technology, an updated electronic Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG) is now being developed along with a clinical dashboard and guidance for the use of mobile technology in supervision. OBJECTIVE: This study aims to assess the feasibility, acceptability, adoption, and other implementation parameters of the e-mhGAP-IG for diagnosis and management of depression in 2 lower-middle-income countries (Nepal and Nigeria) and to conduct a feasibility cluster randomized controlled trial (cRCT) to evaluate trial procedures for a subsequent fully powered trial comparing the clinical effectiveness and cost-effectiveness of the e-mhGAP-IG and remote supervision with standard mhGAP-IG implementation. METHODS: A feasibility cRCT will be conducted in Nepal and Nigeria to evaluate the feasibility of the e-mhGAP-IG for use in depression diagnosis and treatment. In each country, an estimated 20 primary health clinics (PHCs) in Nepal and 6 PHCs in Nigeria will be randomized to have their staff trained in e-mhGAP-IG or the paper version of mhGAP-IG v2.0. The PHC will be the unit of clustering. All PCWs within a facility will receive the same training (e-mhGAP-IG vs paper mhGAP-IG). Approximately 2-5 PCWs, depending on staffing, will be recruited per clinic (estimated 20 health workers per arm in Nepal and 15 per arm in Nigeria). The primary outcomes of interest will be the feasibility and acceptability of training, supervision, and care delivery using the e-mhGAP-IG. Secondary implementation outcomes include the adoption of the e-mhGAP-IG and feasibility of trial procedures. The secondary intervention outcome-and the primary outcome for a subsequent fully powered trial-will be the accurate identification of depression by PCWs. Detection rates before and after training will be compared in each arm. RESULTS: To date, qualitative formative work has been conducted at both sites to prepare for the pilot feasibility cRCT, and the e-mhGAP-IG and remote supervision guidelines have been developed. CONCLUSIONS: The incorporation of mobile digital technology has the potential to improve the scalability of mental health services in primary care and enhance the quality and accuracy of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04522453; https://clinicaltrials.gov/ct2/show/NCT04522453. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/24115.

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.