Using symbiotic empirical ethics to explore the significance of relationships to clinical ethics: findings from the Reset Ethics research project.

BACKGROUND: At the beginning of the coronavirus (Covid-19) pandemic, many non-Covid healthcare services were suspended. In April 2020, the Department of Health in England mandated that non-Covid services should resume, alongside the continuing pandemic response. This 'resetting' of healthcare services created a unique context in which it became critical to consider how ethical considerations did (and should) underpin decisions about integrating infection control measures into routine healthcare practices. We draw on data collected as part of the 'NHS Reset Ethics' project, which explored the everyday ethical challenges of resetting England's NHS maternity and paediatrics services during the pandemic. METHODS: Healthcare professionals and members of the public participated in interviews and focus group discussions. The qualitative methods are reported in detail elsewhere. The focus of this article is our use of Frith's symbiotic empirical ethics methodology to work from our empirical findings towards the normative suggestion that clinical ethics should explicitly attend to the importance of relationships in clinical practice. This methodology uses a five-step approach to refine and develop ethical theory based on a naturalist account of ethics that sees practice and theory as symbiotically related. RESULTS: The Reset project data showed that changed working practices caused ethical challenges for healthcare professionals, and that infection prevention and control measures represented harmful barriers to the experience of receiving and offering care. For healthcare professionals, offering care as part of a relational interaction was an ethically important dimension of healthcare delivery. CONCLUSIONS: Our findings suggest that foregrounding the importance of relationships across a hospital community will better promote the ethically important multi-directional expression of caring between healthcare professionals, patients, and their families. We offer two suggestions for making progress towards such a relational approach. First, that there is a change of emphasis in clinical ethics practice to explicitly acknowledge the importance of the relationships (including with their healthcare team) within which the patient is held. Second, that organisational decision-making should take into account the moral significance afforded to caring relationships by healthcare professionals, and the role such relationships can play in the negotiation of ethical challenges.

Delivering compassionate NHS healthcare: A qualitative study exploring the ethical implications of resetting NHS maternity and paediatric services following the acute phase of the COVID-19 pandemic.

A distinction can be drawn between healthcare, where compassion is evident, and the functional delivery of health services. Measures to curb the spread of COVID-19, such as personal protective equipment, telehealth, and visiting restrictions created barriers to service delivery and put pressure on healthcare. Through 37 qualitative interviews with NHS senior managers (n = 11), health professionals (n = 26), and 5 focus group discussions with members of the public (n = 26), we explored experiences of the everyday ethical tensions created as services were being re-established following the acute phase of the COVID-19 pandemic in England. Our analysis enriches an understanding of compassionate care as outlined in NHS operational documents - covering the emotional, moral, and relational components of healthcare beyond the functionalities of treatment. From this analysis, we consider the normative standards underpinning NHS healthcare, concluding that, wherever possible, offering compassionate healthcare to patients and their families should be facilitated, and health professionals should themselves be compassionately supported in the workplace. Our findings foreground the need to consider the consequences of the short-term adoption of a functional treatment approach, including strategies that support health professionals and inform the public, to avoid the long-term damage caused by the fracturing of compassionate healthcare.

Community based sociotherapy for depressive symptomatology of Congolese refugees in Rwanda and Uganda (CoSTAR): a protocol for a cluster randomised controlled trial.

Background: Conflict in the Democratic Republic of Congo has led to large numbers of refugees fleeing to Uganda and Rwanda. Refugees experience elevated levels of adverse events and daily stressors, which are associated with common mental health difficulties such as depression. The current cluster randomised controlled trial aims to investigate whether an adapted form of Community-based Sociotherapy (aCBS) is effective and cost-effective in reducing depressive symptomatology experienced by Congolese refugees in Uganda and Rwanda.Methods: A two-arm, single-blind cluster randomised controlled trial (cRCT) will be conducted in Kyangwali settlement, Uganda and Gihembe camp, Rwanda. Sixty-four clusters will be recruited and randomly assigned to either aCBS or Enhanced Care As Usual (ECAU). aCBS, a 15-session group-based intervention, will be facilitated by two people drawn from the refugee communities. The primary outcome measure will be self-reported levels of depressive symptomatology (PHQ-9) at 18-weeks post-randomisation. Secondary outcomes will include levels of mental health difficulties, subjective wellbeing, post-displacement stress, perceived social support, social capital, quality of life, and PTSD symptoms at 18-week and 32-week post-randomisation. Cost effectiveness of aCBS will be measured in terms of health care costs (cost per Disability Adjusted Life Year, DALY) compared to ECAU. A process evaluation will be undertaken to investigate the implementation of aCBS.Conclusion: This cRCT will be the first investigating aCBS for mental health difficulties experienced by refugees and will contribute to knowledge about the use of psychosocial interventions for refugees at a time when levels of forced migration are at a record high.Trial registration: ISRCTN.org identifier: ISRCTN20474555.

There is a need to evaluate community-based psychosocial interventions for refugees.Community-based sociotherapy has been used to support communities in post-conflict situations but has not been evaluated in a randomised controlled trial.This protocol outlines a proposed randomised controlled trial of community-based sociotherapy adapted for Congolese refugees in Uganda and Rwanda.

RELATIONSHIPS, RIGHTS, AND RESPONSIBILITIES: (RE)VIEWING THE NHS CONSTITUTION FOR THE POST-PANDEMIC 'NEW NORMAL'.

Action needs to be taken to map out the fairest way to meet the needs of all NHS stakeholders in the post-pandemic 'new normal'. In this article, we review the NHS Constitution, looking at it from a relational perspective and suggesting that it offers a useful starting point for such a project, but that new ways of thinking are required to accommodate the significant changes the pandemic has made to the fabric of the NHS. These new ways of thinking should encompass concepts of solidarity, care, and (reciprocal) responsibility, grounded in an acceptance of the importance of relationships in society. To this end, we explore and emphasise the importance of our interconnections as NHS stakeholders and 're-view' the NHS Constitution from a relational perspective, concentrating on the rights and responsibilities it describes for patients and the public as NHS stakeholders. We argue that the NHS Constitution, of which most stakeholders are probably unaware, can be used as a tool to engage us, and to catalyse conversation about how our responsibilities as NHS stakeholders should change in the post-pandemic 'new normal'.

Translating, contextually adapting, and pilot testing of psychosocial and mental health assessment instruments for Congolese refugees in Rwanda and Uganda.

BACKGROUND: Forcibly displaced people are at elevated risk of experiencing circumstances that can adversely impact on mental health. Culturally and contextually relevant tools to assess their mental health and psychosocial needs are essential to inform the development of appropriate interventions and investigate the effectiveness of such interventions. METHODS: We conducted two related studies: (1) to translate and contextually adapt the Patient Health Questionnaire (PHQ-9), a measure of depressive symptomatology, along with assessment instruments measuring levels of daily stress (Checklist for Daily & Environmental Stressors; CDES), social capital (Shortened and Adapted Social Capital Assessment Tool; SASCAT) and perceived social support (Multidimensional Scale of Perceived Social Support; MSPSS) for use with Congolese refugees; (2) to conduct pilot testing of the assessment instruments (including cognitive interviewing about participants' views of completing them) and a validation of the adapted PHQ-9 using a 'known group' approach by recruiting Congolese refugees from refugee settings in Rwanda (n = 100) and Uganda (n = 100). RESULTS: Study 1 resulted in the translation and adaptation of the assessment instruments. No substantive adaptations were made to the SASCAT or MSPSS, while notable linguistic and contextual adaptations were made in both sites to the CDES and the PHQ-9. The cognitive interviewing conducted in Study 2 indicated that the adapted assessment instruments were generally well received by members of the refugee communities. Participants recruited on the basis that local informants adjudged them to have high levels of depressive symptoms had significantly higher PHQ-9 scores (M = 11.02; SD = 5.84) compared to those in the group adjudged to have low levels of depressive symptoms (M = 5.66; SD = 5.04). In both sites, the adapted versions of the PHQ-9 demonstrated concurrent validity via significant positive correlations with levels of daily stressors. Each of the four adapted assessment instruments demonstrated at least adequate levels of internal consistency in both sites. CONCLUSIONS: The adapted versions of the PHQ-9, CDES, SASCAT and MSPSS are appropriate for use amongst Congolese refugees in Rwanda and Uganda. We recommend further application of the approaches used in the current studies for contextually adapting other assessment instruments in humanitarian settings.

Communication about distress and well-being: Epistemic and ethical considerations.

Communication about well-being and distress involves multiple stakeholders, including experts by experience (EBE), researchers, clinical practitioners, interpreters, and translators. Communication can involve a variety of discourses and languages and each of the stakeholders may employ diverging epistemologies to understand and explain experiences. These epistemologies may link to different sources of authority and be articulated using particular linguistic resources. Epistemic injustice can occur when stakeholders, intentionally or unintentionally, fail to recognise the validity of other stakeholders' ways of conceptualising and verbalising their experience of well-being and distress. Language lies at the heart of the risk of epistemic injustice involved in the process of expressing well-being and distress as seen in: 1) the interface between divergent discourses on well-being and distress (e.g., biomedical vs. spiritual); and 2) communications involving multiple linguistic resources, which can be subdivided into multi-language communications involving a) translation of assessment measures, and b) interpreted interactions. Some of the challenges of multi-language communication can be addressed by translators or interpreters who strive for conceptual equivalence. We argue, however, that all stakeholders have an important role as "epistemic brokers" in the languaging of possible epistemological differences. Effective epistemic brokering requires that all stakeholders are reflexively and critically aware of the risks of epistemic injustice inherent in multi-language communication. The article concludes with a set of prompts to help raise stakeholder awareness and reflexivity when engaging in communication about well-being and distress.

The 'good life', personal appearance, and mental health of Congolese refugees in Rwanda and Uganda.

RATIONALE: Research into mental health and wellbeing recognises the role of positive mental health to enable people to lead healthy and emotionally fulfilling lives. Mental health difficulties continue to be associated with high levels of disability worldwide, and refugees fleeing conflict are known to suffer from poor mental health for years after their forced migration. METHOD: Informed by Sen's Capability Approach and as part of a wider research project, we used semi-structured interviews to engage with 60 men and women in two refugee communities in Uganda and Rwanda to explore their aspirations and what a 'good life' meant to them. FINDINGS: While aspects of what constituted a good life were gendered, both men and women struggled to achieve their aspirations within their communities. Following the basic needs of food and shelter, the complex needs of being dressed well and being clean were consistently associated with be able to achieve a 'good life' by women and men across age groups. Looking good and being clean were highly valued and associated with gaining the respect of others, achieving good relationships with neighbours, and avoiding conflict. Participants identified personal appearance and related social status as critical precursors to their successful engagement with other gendered dimensions of social and economic life in their communities, such as finding employment and being well regarded in their religious communities. CONCLUSIONS: Our findings suggest that without the means to present a good appearance, people living in refugee communities may experience feelings of shame and isolation and are unable to gain self-respect and the respect of others needed to achieve the positive mental and physical health they associate with leading 'a good life'.

Application of the capability approach to Indigenous People's health and well-being: protocol for a mixed-methods scoping review.

BACKGROUND: Indigenous Peoples are subject to marginalisation, and experience systematic disadvantage in relation to health outcomes. Human development initiatives may help determine whether, and how, Indigenous Peoples are able to be agents of their own development and improve their health and well-being. This scoping review protocol outlines a process for synthesising the existing evidence that has applied the capability approach (CA) to Indigenous People's health and/or well-being. METHODS AND ANALYSIS: A mixed-method scoping review is proposed including academic peer-reviewed publications and grey literature. Screening inclusion criteria will include Indigenous populations, using the CA approach to conceptualise health and/or well-being, and be available in English, Spanish, French or Portuguese. Publications that meet these criteria will undergo data extraction. Qualitative and quantitative data will be thematically and descriptively analysed and interpreted. ETHICS AND DISSEMINATION: The proposed scoping review does not involve collecting data directly from Indigenous Peoples but will be based on previous research conducted within Indigenous settings. The current protocol and the proposed scoping review incorporate aspects of community involvement to guide the research process.This scoping review constitutes the first phase of a wider participatory action research project conducted with the Indigenous Kankuamo Peoples of Colombia. The findings of this review will be reported to local partners, published in a peer-reviewed journal and an executive summary will be shared with wider stakeholders. Within the wider project, the review will be considered alongside primary data to inform the development of tools/approaches of mental health and well-being for the Kankuamo communities.

Maximising impactful, locally relevant global mental health research conducted in low and middle income country settings: ethical considerations.

Background: Achieving ethical and meaningful mental health research in diverse global settings requires approaches to research design, conduct, and dissemination that prioritise a contextualised approach to impact and local relevance. Method: Through three case studies presented at the 2021 Global Forum on Bioethics in Research meeting on the ethical issues arising in research with people with mental health conditions, we consider the nuances to achieving ethical and meaningful mental health research in three diverse settings. The case studies include research with refugees Rwanda and Uganda; a neurodevelopmental cohort study in a low resource setting in India, and research with Syrian refugees displaced across the Middle East. Results: Key considerations highlighted across the case studies include how mental health is understood and experienced in diverse contexts to ensure respectful engagement with communities, and to inform the selection of contextually-appropriate and feasible research methods and tools to achieve meaningful data collection.  Related to this is a need to consider how communities understand and engage with research to avoid therapeutic misconception, exacerbating stigma, or creating undue inducement for research participation, whilst also ensuring meaningful benefit for research participation. Central to achieving these is the meaningful integration of the views and perspectives of local stakeholders to inform research design, conduct, and legacy. The case studies foreground the potential tensions between meeting local community needs through the implementation of an intervention, and attaining standards of scientific rigor in research design and methods; and between adherence to procedural ethical requirements such as ethical review and documenting informed consent, and ethical practice through attention to the needs of the local research team. Conclusions: We conclude that engagement with how to achieve local relevance and social, practice, and academic impact offer productive ways for researchers to promote ethical research that prioritises values of solidarity, inclusion, and mutual respect.

Which ethical values underpin England's National Health Service reset of paediatric and maternity services following COVID-19: a rapid review.

OBJECTIVE: To identify ethical values guiding decision making in resetting non-COVID-19 paediatric surgery and maternity services in the National Health Service (NHS). DESIGN: A rapid review of academic and grey literature sources from 29 April to 31 December 2020, covering non-urgent, non-COVID-19 healthcare. Sources were thematically synthesised against an adapted version of the UK Government's Pandemic Flu Ethical Framework to identify underpinning ethical principles. The strength of normative engagement and the quality of the sources were also assessed. SETTING: NHS maternity and paediatric surgery services in England. RESULTS: Searches conducted 8 September-12 October 2020, and updated in March 2021, identified 48 sources meeting the inclusion criteria. Themes that arose include: staff safety; collaborative working - including mutual dependencies across the healthcare system; reciprocity; and inclusivity in service recovery, for example, by addressing inequalities in service access. Embedded in the theme of staff and patient safety is embracing new ways of working, such as the rapid roll out of telemedicine. On assessment, many sources did not explicitly consider how ethical principles might be applied or balanced against one another. Weaknesses in the policy sources included a lack of public and user involvement and the absence of monitoring and evaluation criteria. CONCLUSIONS: Our findings suggest that relationality is a prominent ethical principle informing resetting NHS non-COVID-19 paediatric surgery and maternity services. Sources explicitly highlight the ethical importance of seeking to minimise disruption to caring and dependent relationships, while simultaneously attending to public safety. Engagement with ethical principles was ethics-lite, with sources mentioning principles in passing rather than explicitly applying them. This leaves decision makers and healthcare professionals without an operationalisable ethical framework to apply to difficult reset decisions and risks inconsistencies in decision making. We recommend further research to confirm or refine the usefulness of the reset phase ethical framework developed through our analysis.

Addressing the Consequences of the COVID-19 Lockdown for Children's Mental Health: Investing in School Mental Health Programs.

Children are likely to struggle with mental health consequences relating to the COVID-19 pandemic. School closures and home confinement increase the risk for emotional distress, domestic violence and abuse, and social isolation, as well as for disruption of sleep-wake and meal cycles, physical exercise routines, and health care access. As schools reopen, school mental health programs (SMHPs) incorporating universal approaches will be important for all children, and targeted approaches will be necessary for those more severely affected. Using their experience in Pakistan, the authors provide a roadmap for extending the World Health Organization's eastern Mediterranean region's SMHP to address the mental health consequences of COVID-19 among children globally.

Exploring the mental health and psychosocial problems of Congolese refugees living in refugee settings in Rwanda and Uganda: a rapid qualitative study.

BACKGROUND: Refugees fleeing conflict often experience poor mental health due to experiences in their country of origin, during displacement, and in new host environments. Conditions in refugee camps and settlements, and the wider socio-political and economic context of refugees' lives, create structural conditions that compound the effects of previous adversity. Mental health and psychosocial support services must address the daily stressors and adversities refugees face by being grounded in the lived reality of refugee's lives and addressing issues relevant to them. METHODS: We undertook a rapid qualitative study between March and May 2019 to understand the local prioritisation of problems facing Congolese refugees living in two refugee settings in Uganda and Rwanda. Thirty free list interviews were conducted in each setting, followed by 11 key informant interviews in Uganda and 12 in Rwanda. RESULTS: Results from all interviews were thematically analysed following a deductive process by the in-country research teams. Free list interview findings highlight priority problems of basic needs such as food, shelter, and healthcare access; alongside contextual social problems including discrimination/inequity and a lack of gender equality. Priority problems relating to mental and psychosocial health explored in key informant interviews include discrimination and inequity; alcohol and substance abuse; and violence and gender-based violence. CONCLUSIONS: Our findings strongly resonate with models of mental health and psychosocial wellbeing that emphasise their socially determined and contextually embedded nature. Specifically, findings foreground the structural conditions of refugees' lives such as the physical organisation of camp spaces or refugee policies that are stigmatising through restricting the right to work or pursue education. This structural environment can lead to disruptions in social relationships at the familial and community levels, giving rise to discrimination/inequity and gender-based violence. Therefore, our findings foreground that one consequence of living in situations of pervasive adversity caused by experiences of discrimination, inequity, and violence is poor mental health and psychosocial wellbeing. This understanding reinforces the relevance of feasible and acceptable intervention approaches that aim to strengthening familial and community-level social relationships, building upon existing community resources to promote positive mental health and psychosocial wellbeing among Congolese refugees in these settings.

Identifying pathways for large-scale implementation of a school-based mental health programme in the Eastern Mediterranean Region: a theory-driven approach.

Globally there is a substantial burden of mental health problems among children and adolescents. Task-shifting/task-sharing mental health services to non-specialists, e.g. teachers in school settings, provide a unique opportunity for the implementation of mental health interventions at scale in low- and middle-income countries (LMICs). There is scant information to guide the large-scale implementation of school-based mental health programme in LMICs. This article describes pathways for large-scale implementation of a School Mental Health Program (SMHP) in the Eastern Mediterranean Region (EMR). A collaborative learning group (CLG) comprising stakeholders involved in implementing the SMHP including policymakers, programme managers and researchers from EMR countries was established. Participants in the CLG applied the theory of change (ToC) methodology to identify sets of preconditions, assumptions and hypothesized pathways for improving the mental health outcomes of school-aged children in public schools through implementation of the SMHP. The proposed pathways were then validated through multiple regional and national ToC workshops held between January 2017 and September 2019, as the SMHP was being rolled out in three EMR countries: Egypt, Pakistan and Iran. Preconditions, strategies and programmatic/contextual adaptations that apply across these three countries were drawn from qualitative narrative summaries of programme implementation processes and facilitated discussions during biannual CLG meetings. The ToC for large-scale implementation of the SMHP in the EMR suggests that identifying national champions, formulating dedicated cross-sectoral (including the health and education sector) implementation teams, sustained policy advocacy and stakeholders engagement across multiple levels, and effective co-ordination among education and health systems especially at the local level are among the critical factors for large-scale programme implementation. The pathways described in this paper are useful for facilitating effective implementation of the SMHP at scale and provide a theory-based framework for evaluating the SMHP and similar programmes in the EMR and other LMICs.

Writing to template: Researchers' negotiation of procedural research ethics.

This qualitative study examines researchers' views of research ethics in everyday global mental health research practice. We present data from a multi-site study conducted in 2014-15 involving 35 individual in-depth interviews that explore researchers' perceptions of procedural ethics in research conducted in South Asia. We examine how researchers' negotiate ethical procedures, and consider the impact this has on ethical practice. This study foregrounds researchers' pivotal role in procedural research ethics: they produce ethical documents including research protocols and informed consent forms; engage in ethical review; and apply ethical documents to research practice. We apply the analytical framework of boundary objects to show the active work that ethical documents simultaneously enable and inhibit as researchers and ethical review boards apply these as templates for interaction. This analysis shows how the documents required by procedural ethics processes facilitate representations of research that are generalised, standardised, and abstracted from the situated context in which they are applied. Researchers' engagement with these standardised forms cannot prepare them for potential ethical issues in research practice. These templates therefore act as ideal constructions of what research ethics could be, documenting moral intent that researchers draw upon to translate into practice.

Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial.

BACKGROUND: Asylum seekers and refugees (AS&Rs) experience impaired mental health and wellbeing, related to stresses in their country of origin, experiences in transit and reception on arrival, including significant barriers to accessing mainstream services. Their contact with health care is often crisis-driven and mediated through non-governmental organisations (NGOs). Problem Management Plus (PM+) is a psychosocial intervention recommended by the World Health Organisation to address distress experienced by adults affected by humanitarian crises. We are investigating its application for the first time in a high-income country. METHODS: In a pilot randomised controlled trial (RCT), PM+ will be delivered to AS&Rs in contact with NGOs in Liverpool City Region, UK by lay therapists who have lived experience of forced migration. Following systematic review and stakeholder engagement, PM+ has been adapted to the local context, and lay therapists have been trained in its delivery. We will assess the feasibility of conducting a three-arm RCT of five 90-min sessions of PM+, delivered individually or in groups by lay therapists to AS&Rs experiencing emotional distress and functional impairment, compared with each other and with usual support offered by local NGOs. Distress and impairment at baseline will be measured by the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule (WHO-DAS). We aim to recruit 105 participants, 35 per arm. Primary health outcomes are anxiety and depressive symptoms at 3 months, measured by HADS. Secondary outcomes include subjective wellbeing, functional status, progress on identified problems, presence of post-traumatic stress disorder and depressive disorder and service usage. Longer-term impact will be assessed at 6 months post baseline, on the same parameters. We will assess the feasibility of conducting a full RCT in relation to the following elements: recruitment and retention of lay therapists and study participants; fidelity of delivery of PM+; and suitability of the study measures, including any linguistic or cultural barriers. DISCUSSION: We will use these findings to specify the parameters for a full RCT to test the effectiveness and cost-effectiveness of PM+ in reducing emotional distress and health inequalities, and improving functional ability and wellbeing, amongst asylum seekers and refugees. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN15214107. Registered on 10 September 2019.

Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial.

BACKGROUND: Many women are affected by anxiety and depression after armed conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. METHODS: In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. FINDINGS: From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. INTERPRETATION: Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. FUNDING: WHO through a grant from the Office for Foreign Disaster Assistance.

Correction to: Problem management plus (PM+) for common mental disorders in a humanitarian setting in Pakistan; study protocol for a randomised controlled trial (RCT).

Following publication of the original article [1], the first author reported an error in referring his paper.