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

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

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

Un estudio longitudinal de la salud mental antes y durante la pandemia por la COVID-19 en refugiados sirios

Background: The COVID-19 pandemic has resulted in increased anxiety and depression around the world. Refugees may be particularly vulnerable to the mental health effects of the pandemic because of their higher rates of mental health disorders, trauma histories, and daily stressors. Objectives: This study used data from a controlled trial of a brief behavioural intervention for psychological distress in Syrian refugees living in Azraq Camp in Jordan to examine the psychological effects of the pandemic on refugee mental health. Method: A total of 410 participants were randomized to either the intervention or control arms of the trial and were assessed at baseline and 3-month follow-up. Half the sample (199; 48.5%) completed their 3-month follow-up assessment after the pandemic restrictions began in Jordan and 211 (51.5%) completed the assessment prior to the pandemic. Refugees were independently assessed for symptoms of PTSD, anxiety, and depression at baseline and follow-up, and pandemic-related worries were assessed at follow-up for those who completed their assessment during the pandemic. Results: The most commonly reported worries were economic difficulties (82.4%), shortage of essential supplies (71.3%), and infecting others (59.7%) or themselves (51.9%). Refugees who were assessed during the pandemic had less severe PTSD symptoms than those assessed prior to the pandemic. Significant predictors of pandemic-related worries were lower levels of depression prior to the pandemic and greater anxiety during the pandemic. Conclusion: These findings highlight the specific needs of refugees during the pandemic and suggest that pre-existing mental health issues may not necessarily be the key risk factors for who will experience major mental health issues or worries during the pandemic

A longitudinal study of mental health before and during the COVID-19 pandemic in Syrian refugees

Background: The COVID-19 pandemic has resulted in increased anxiety and depression around the world. Refugees may be particularly vulnerable to the mental health effects of the pandemic because of their higher rates of mental health disorders, trauma histories, and daily stressors. Objectives: This study used data from a controlled trial of a brief behavioural intervention for psychological distress in Syrian refugees living in Azraq Camp in Jordan to examine the psychological effects of the pandemic on refugee mental health. Method: A total of 410 participants were randomized to either the intervention or control arms of the trial and were assessed at baseline and 3-month follow-up. Half the sample (199; 48.5%) completed their 3-month follow-up assessment after the pandemic restrictions began in Jordan and 211 (51.5%) completed the assessment prior to the pandemic. Refugees were independently assessed for symptoms of PTSD, anxiety, and depression at baseline and follow-up, and pandemic-related worries were assessed at follow-up for those who completed their assessment during the pandemic. Results: The most commonly reported worries were economic difficulties (82.4%), shortage of essential supplies (71.3%), and infecting others (59.7%) or themselves (51.9%). Refugees who were assessed during the pandemic had less severe PTSD symptoms than those assessed prior to the pandemic. Significant predictors of pandemic-related worries were lower levels of depression prior to the pandemic and greater anxiety during the pandemic. Conclusion: These findings highlight the specific needs of refugees during the pandemic and suggest that pre-existing mental health issues may not necessarily be the key risk factors for who will experience major mental health issues or worries during the pandemic

Group problem management plus (gPM+) in the treatment of common mental disorders in Syrian refugees in a Jordanian camp:Study protocol for a randomized controlled trial

Background: Accessing quality mental health care poses significant challenges for persons affected by adversity, especially in low- A nd middle-income countries where resources are scarce. To mitigate this, the World Health Organization has developed group problem management plus (gPM+), a low-intensity psychological intervention for adults experiencing psychological distress. gPM+ is a group-based intervention consisting of five-sessions, and can be delivered by non-specialist providers. This paper outlines the study protocol for a trial of gPM+ in Jordan. Methods: We will conduct a single-blind, two-arm, randomized controlled trial in a Syrian refugee camp in Jordan. We aim to enrol 480 adults into the trial. Participants will be eligible for the trial if they screen positive for levels of psychological distress. Following screening, those eligible will be randomly assigned to receive the gPM+ intervention or enhanced treatment as usual. The primary outcome is reduction in levels of psychological distress at 3-months post-treatment. Secondary outcomes include anxiety, depression, prodromal psychotic symptoms, posttraumatic stress disorder, prolonged grief, daily functioning, economic effectiveness, and change in parenting behaviour. Secondary outcomes also include the reduction in psychological distress of the participant's child. Discussion: The trial aims to deliver a template for affordable and scalable psychosocial interventions that can readily be implemented in refugee settings, and that can benefit both the participant and their child. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12619001386123. Registered prospectively on 10/10/2019

Feasibility trial of a scalable transdiagnostic group psychological intervention for Syrians residing in a refugee camp

Background Approximately 10% of Syrian refugees currently reside in camp settings, which can impose additional post-migration stressors. With elevated rates of psychological distress and few available resources, task-shifting psychosocial programmes are necessary to provide adequate care. One such programme developed by the World Health Organization (WHO) is Group Problem Management Plus (GroupPM+). Objective This study aimed to test the safety and acceptability of GroupPM+ in a refugee camp and to identify areas for adaptation in preparation for a definitive RCT. Method A feasibility randomized controlled trial (RCT) was conducted in Azraq refugee camp in Jordan. Inclusion criteria were: (1) Syrian adults aged ≥18 years, (2) parent of a child aged 10–16 years, (3) experiencing psychological distress as defined by a score of ≥16 on the Kessler Distress Scale, and (4) ≥17 on the WHO Disability Assessment Schedule 2.0. Following baseline assessments, participants were randomized to receive GroupPM+ or enhanced treatment-as-usual. Post-assessments were conducted one week following the last GroupPM+ session. Primary outcomes were feasibility and acceptance of GroupPM+; symptoms of anxiety, depression, PTSD, prodromal psychosis, grief, and child’s self-reported psychological distress were also assessed. Results Of the 207 persons screened, 64 (31%) screened positive for psychological distress. Of the 35 randomized into the GroupPM+ intervention, 24 (69%) completed the intervention. No adverse events were reported throughout the trial. Children whose parents received GroupPM+ had greater reductions in internalizing and externalizing symptoms at posttreatment. 55 (86%) participants completed the post-assessment follow-up. These results demonstrate both the feasibility of conducting the trial in a camp and acceptance of the GroupPM+ intervention by Syrian refugees. Conclusions Following the feasibility trial, both the implementation procedures and intervention were safe and culturally acceptable. The results support the readiness for a definitive RCT to determine the effectiveness and cost-effectiveness of the intervention in camp settings

Scaling up task-sharing psychological interventions for refugees in Jordan: a qualitative study on the potential barriers and facilitators

Training nonspecialists in providing evidence-based psychological interventions (i.e. task-sharing) can effectively increase community access to psychological support. However, task-sharing interventions for this purpose are rarely used at scale. The aim of this study was to examine the factors influencing the potential for scaling up (i.e. scalability) of a task-sharing psychological intervention called Problem Management Plus (PM+) for Syrian refugees in Jordan. Semi-structured individual (n = 17) and group interviews (n = 20) were conducted with stakeholders knowledgeable about PM+ and the mental health system for Syrian refugees in Jordan. Using 'system innovation perspective', this study conceptualized the context as landscape developments, and systemic considerations were divided into culture (shared ways of thinking) and structure (ways of organizing). Political momentum was identified as a landscape trend likely facilitating scaling up, while predicted reductions in financial aid was regarded as a constraint. In terms of culture, the medicalized approach to mental health, stigma and gender were reported barriers for scaling up PM+. Using non-stigmatizing language and offering different modalities, childcare options and sessions outside of working hours were suggestions to reduce stigma, accommodate individual preferences and increase the demand for PM+. In relation to structure, the feasibility of scaling up PM+ largely depends on the ability to overcome legal barriers, limitations in human and financial resources and organizational challenges. We recommend sustainable funding to be made available for staff, training, supervision, infrastructure, coordination, expansion and evaluation of 'actual' scaling up of PM+. Future research may examine the local feasibility of various funding, training and supervision models. Lessons learned from actual scaling up of PM+ and similar task-sharing approaches need to be widely shared

Global economic burden of unmet surgical need for appendicitis

Background There is a substantial gap in provision of adequate surgical care in many low- and middle-income countries. This study aimed to identify the economic burden of unmet surgical need for the common condition of appendicitis. Methods Data on the incidence of appendicitis from 170 countries and two different approaches were used to estimate numbers of patients who do not receive surgery: as a fixed proportion of the total unmet surgical need per country (approach 1); and based on country income status (approach 2). Indirect costs with current levels of access and local quality, and those if quality were at the standards of high-income countries, were estimated. A human capital approach was applied, focusing on the economic burden resulting from premature death and absenteeism. Results Excess mortality was 4185 per 100 000 cases of appendicitis using approach 1 and 3448 per 100 000 using approach 2. The economic burden of continuing current levels of access and local quality was US $92 492 million using approach 1 and$73 141 million using approach 2. The economic burden of not providing surgical care to the standards of high-income countries was $95 004 million using approach 1 and$75 666 million using approach 2. The largest share of these costs resulted from premature death (97.7 per cent) and lack of access (97.0 per cent) in contrast to lack of quality. Conclusion For a comparatively non-complex emergency condition such as appendicitis, increasing access to care should be prioritized. Although improving quality of care should not be neglected, increasing provision of care at current standards could reduce societal costs substantially