How to distinguish promotion, prevention and treatment trials in public mental health? Study protocol for the development of the VErona-LUgano Tool (VELUT).

INTRODUCTION: Promoting mental health, preventing and treating mental disorders are critically important in public health, and many randomised controlled trials (RCTs) evaluate intervention strategies for these objectives. However, distinguishing promotion from prevention and from treatment RCTs is challenging. A tool to place studies along the promotion-to-treatment continuum in mental health research does not exist, leaving it to researchers and policymakers to decide on how to classify individual RCTs, which hinders evidence synthesis. METHODS AND ANALYSIS: We present a protocol for the development of a new tool to assist researchers in distinguishing RCTs along the promotion-to-treatment continuum. We will establish a Tool Development Group, and use the Population, Intervention, Comparison and Outcome framework to define constructs. We will generate, define, categorise and reduce the items in the tool using qualitative methods, including cognitive interviews and a Delphi exercise. Psychometric evaluation-including unidimensionality, local independence, monotonicity and item homogeneity-will include data collection, scoring, internal consistency checks and factor analysis of the tool's indicators for available RCTs. We will use standard Cohen's kappa statistics to assess the reliability of the tool. ETHICS AND DISSEMINATION: This study involves data collection from the already published literature. However, this protocol has been approved by the ethics committee of the Università della Svizzera Italiana (CE 2024 04). The results of the present project will be disseminated in peer-reviewed journals and at international and national scientific meetings. Training materials for the application of the tool will also be developed and disseminated to the scientific community. The tool and all related implementation materials will be published on a website and will be freely accessible to the public.

Effect of trauma on asylum seekers and refugees receiving a WHO psychological intervention: a mediation model.

Background: Scalable psychological interventions such as the WHO's Self-Help Plus (SH+) have been developed for clinical and non-clinical populations in need of psychological support. SH+ has been successfully implemented to prevent common mental disorders among asylum seekers and refugees who are growing in number due to increasing levels of forced migration. These populations are often exposed to multiple, severe sources of traumatisation, and evidence of the effect of such events on treatment is insufficient, especially for non-clinical populations.Objective: We aim to study the effect of potentially traumatic experiences (PTEs) and the mediating role of symptoms of posttraumatic stress disorder (PTSD) on the improvement following SH+.Method: Participants allocated to SH+ who received at least three sessions (N = 345) were extracted from two large, randomised, European prevention trials involving asylum seekers and refugees. Measures of distress, depression, functional impairment, and post-traumatic stress symptoms were administered at baseline and 6 months post-intervention, together with measures of well-being and quality of life. Adjusted models were constructed to examine the effect of PTEs on post-intervention improvement. The possible mediating role of PTSD symptoms in this relationship was then tested.Results: Increasing numbers of PTEs decreased the beneficial effect of SH+ for all measures. This relationship was mediated by symptoms of PTSD when analysing measures of well-being and quality of life. However, this did not apply for measures of mental health problems.Conclusions: Exposure to PTEs may largely reduce benefits from SH+. PTSD symptomatology plays a specific, mediating role on psychological well-being and quality of life of participants who experienced PTE. Healthcare professionals and researchers should consider the role of PTEs and PTSD symptoms in the treatment of migrants and refugees and explore possible feasible add-on solutions for cases exposed to multiple PTEs.

Increasing numbers of potentially traumatic experiences can decrease the beneficial effect of a manualized group psychotherapeutic intervention in migrants and refugees across multiple countries.In absence of a full threshold diagnosis of post-traumatic stress disorder, post-traumatic stress symptoms still mediate the relation between potentially traumatic experiences and some outcome improvements at follow-up.While the moderating role of number of potentially traumatic experiences applies to all outcomes (depression symptoms, psychological distress, functional impairment, well-being, and quality of life), the mediating role of post-traumatic stress symptoms in this relation only applies to well-being and quality of life.

Impairments in psychological functioning in refugees and asylum seekers.

Refugees are at increased risk for developing psychological impairments due to stressors in the pre-, peri- and post-migration periods. There is limited knowledge on how everyday functioning is affected by migration experience. In a secondary analysis of a study in a sample of refugees and asylum seekers, it was examined how aspects of psychological functioning were differentially affected. 1,101 eligible refugees and asylum seekers in Europe and Türkiye were included in a cross-sectional analysis. Gender, age, education, number of relatives and children living nearby, as well as indicators for depressive and posttraumatic symptoms, quality of life, psychological well-being and functioning, and lifetime potentially traumatic events were assessed. Correlations and multiple regression models with World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version's total and six subdomains' scores ('mobility', 'life activities', 'cognition', 'participation', 'self-care', 'getting along') as dependent variables were calculated. Tests for multicollinearity and Bonferroni correction were applied. Participants reported highest levels of impairment in 'mobility' and 'participation', followed by 'life activities' and 'cognition'. Depression and posttraumatic symptoms were independently associated with overall psychological functioning and all subdomains. History of violence and abuse seemed to predict higher impairment in 'participation', while past events of being close to death were associated with fewer issues with 'self-care'. Impairment in psychological functioning in asylum seekers and refugees was related to current psychological symptoms. Mobility and participation issues may explain difficulties arising after resettlement in integration and exchange with host communities in new contexts.

Health system responsiveness to the mental health needs of Syrian refugees: mixed-methods rapid appraisals in eight host countries in Europe and the Middle East.

Background: Syrian refugees have a high burden of mental health symptoms and face challenges in accessing mental health and psychosocial support (MHPSS). This study assesses health system responsiveness (HSR) to the MHPSS needs of Syrian refugees, comparing countries in Europe and the Middle East to inform recommendations for strengthening MHPSS systems. Methods: A mixed-methods rapid appraisal methodology guided by an adapted WHO Health System Framework was used to assess HSR in eight countries (Egypt, Germany, Jordan, Lebanon, Netherlands, Sweden, Switzerland, and Türkiye). Quantitative and qualitative analysis of primary and secondary data was used. Data collection and analysis were performed iteratively by multiple researchers. Country reports were used for comparative analysis and synthesis. Results: We found numerous constraints in HSR: i) Too few appropriate mental health providers and services; ii) Travel-related barriers impeding access to services, widening rural-urban inequalities in the distribution of mental health workers; iii) Cultural, language, and knowledge-related barriers to timely care likely caused by insufficient numbers of culturally sensitive providers, costs of professional interpreters, somatic presentations of distress by Syrian refugees, limited mental health awareness, and stigma associated to mental illness; iv) High out-of-pocket costs for psychological treatment and transportation to services reducing affordability, particularly in middle-income countries; v) Long waiting times for specialist mental health services; vi) Information gaps on the mental health needs of refugees and responsiveness of MHPSS systems in all countries. Six recommendations are provided to address these issues. Conclusions: All eight host countries struggle to provide responsive MHPSS to Syrian refugees. Strengthening the mental health workforce (in terms of quantity, quality, diversity, and distribution) is urgently needed to enable Syrian refugees to receive culturally appropriate and timely care and improve mental health outcomes. Increased financial investment in mental health and improved health information systems are crucial.

Background: People who experience war often have increased mental health problems. Those who are forced to flee abroad frequently struggle to access adequate mental health and psychosocial support services. As a result, many refugees often do not seek or use such services.Researchers of the Syrian REfuGees MeNTal HealTH Care Systems (STRENGTHS) consortium carried out rapid appraisals to assess the responsiveness of health systems to the mental health and psychosocial needs of Syrian refugees in eight countries: Egypt, Germany, Jordan, Lebanon, the Netherlands, Sweden, Switzerland, and Türkiye. They used quantitative and qualitative data, including primary and secondary data. This paper summarises and compares findings from the eight countries. What is health system responsiveness?: The ability of a health system to meet the expectations and needs of its people with regards to access, coverage, quality, and safety of services. What are our main findings and recommendations?: We found that all eight host countries struggle to provide responsive mental health and psychosocial support to Syrian refugees. We identified the following key challenges: Insufficient mental health providers and services, including uneven rural-urban distribution;Cultural, language, and knowledge-related barriers to timely care, caused by insufficient culturally sensitive providers and mental health stigma among Syrian refugee communities;Out-of-pocket costs for psychological treatment and transportation to services;Long waiting times for specialist mental health services;Information gaps on the mental health needs of Syrian refugees;We recommend increasing national funding for mental health to help Syrian refugees to receive more culturally appropriate and timely care. Increased funding can reduce out-of-pocket payments by refugees, improve national health information systems, and strengthen the mental health workforce (in terms of quantity, quality, diversity, and distribution). We also recommend investment in cultural competency and mental health training for community-based workers and primary care providers.