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Background: Achieving system-level, sustainable ‘scale-up’ of interventions is the epitome of successful translation of evidence-based approaches in population health. In physical activity promotion, few evidence-based interventions reach implementation at scale or become embedded within systems for sustainable health impact. This is despite the vast published literature describing efficacy studies of small-scale physical activity interventions. Research into physical activity scale-up (through case-study analysis; evaluations of scale-up processes in implementation trials; and mapping the processes, strategies, and principles for scale-up) has identified barriers and facilitators to intervention expansion. Many interventions are implemented at scale by governments but have not been evaluated or have unpublished evaluation information. Further, few public health interventions have evaluations that reveal the costs and benefits of scaled-up implementation. This lack of economic information introduces an additional element of risk for decision makers when deciding which physical activity interventions should be supported with scarce funding resources. Decision-makers face many other challenges when scaling interventions which do not relate to formal research trials of scale-up; Methods: To explore these issues, a multidisciplinary two-day workshop involving experts in physical activity scale-up was convened by the University of Newcastle, Australia, and the University of Ottawa, Canada (February 2019); Results: In this paper we discuss some of the scale-up tensions (challenges and conflicts) and paradoxes (things that are contrary to expectations) that emerged from this workshop in the context of the current literature and our own experiences in this field. We frame scale-up tensions according to epistemology, methodology, time, and partnerships; and paradoxes as ‘reach without scale’, ‘planned serendipity’ and ‘simple complexity’. We reflect on the implications of these scale-up tensions and paradoxes, providing considerations for future scale-up research and practice moving forward; Conclusions: In this paper, we delve deeper into stakeholders’ assumptions, processes and expectations of scaling up, and challenge in what ways as stakeholders, we all contribute to desired or undesired outcomes. Through a lens of ‘tensions’ and ‘paradoxes’, we make an original contribution to the scale-up literature that might influence current perspectives of scaling-up, provide future approaches for physical activity promotion, and contribute to understanding of dynamic of research-practice partnerships.

Objectives When it comes to interviewing suspected terrorists, global evidence points to harsh interrogation procedures, despite the likelihood of false positives. How can the state maintain an effective counterterrorism policy while simultaneously protecting civil rights? Until now, the shroud of secrecy of “national security” practices has thwarted attempts by researchers to test apparatuses that engender fair interrogation procedures. The present study aims to test one approach: the use of a “procedural justice checklist” (PJ Checklist) in interviews of suspected terrorists by counterterrorism police officers in port settings. Methods Using a clustered randomized controlled field test in a European democracy, we measure the effect of implementing Procedural Justice (PJ) Checklists in counterterrorism police settings. With 65 teams of officers randomly-assigned into treatment and control conditions, we compare post-interrogation surveys of suspects ( n  = 1418) on perceptions of legitimacy; obligations to obey the law; willingness to cooperate with the police; effectiveness of counterterrorism measures; distributive justice; feelings of social resistance to the state; and PJ. A series of multi-level linear, logistic, and ordered logit regression models are used to estimate the treatment effect, with Hedges’ g and odds ratios used for effect sizes. Results When compared with control conditions, implementing a policy of PJ Checklist causes statistically significant and large enhancement in all measured dimensions, including the willingness of suspects to obey the law ( g  = 1.022 [0.905, 1.138]), to cooperate with the police ( g  = 1.118 [0.999, 1.238]), distributive justice ( g  = 0.993 [0.880, 1.106]), effectiveness ( g  = 1.077 [0.959, 1.195]), procedural justice ( g  = 1.044 [0.930, 1.158]), and feelings of resistance towards the state ( g  = − 0.370 [− 0.259, − 0.482]). Conclusions PJ checklists offer a simple, scalable means of improving how state agents interact with terrorism suspects. The police can use what is evidently a cost-effective tool to enhance legitimacy and cooperation with the police, even in a counterterrorism environment.

: The full-scale Russian invasion of Ukraine on 24 February 2022 has led to millions of forcibly displaced persons (FDPs) within Ukraine and other European countries. Due to war-related exposure and displacement adversities, this group is at significant risk of developing depression, anxiety, post-traumatic stress disorder, and other mental health problems. Systemic barriers, including insufficiently equipped mental health systems and language barriers, prevent FDPs from receiving adequate mental health and psychosocial support (MHPSS). Scalable interventions delivered in person by non-specialist helpers, or digitally, provide opportunities to scale up the MHPSS response. : This paper aims to provide an overview of the 'Ukraine's displaced people in the EU: Reach out, Implement, Scale-up and Evaluate interventions promoting mental wellbeing' (U-RISE) project. U-RISE aims to improve the mental wellbeing of FDPs from Ukraine by establishing a network of Ukrainian mental health professionals, building sustainable capacity for provision and supporting implementation of scalable face-to-face and digital mental health interventions adapted to the specific needs of this population. We build capacity for and implement scalable face-to-face interventions, including Problem Management Plus, Self Help Plus, and Multi-family Approach, for FDPs from Ukraine in Poland, Slovakia and Romania. Digital interventions, including the Doing What Matters in Times of Stress digital guide and a Telegram-based chatbot 'Friend' using principles of Psychological First Aid, are being implemented in Europe and Ukraine. To monitor the population's mental wellbeing and impact of the interventions, qualitative needs assessments among mental health providers and FDPs, and quantitative assessments pre- and post-intervention are collected. : We provide a framework for the rapid implementation of face-to-face and digital interventions in countries that need to scale up their MHPSS in response to humanitarian or complex emergency crises.

AimsThere is increasing evidence that brief psychological interventions delivered by lay providers can reduce common mental disorders in the short-term. This study evaluates the longer-term impact of a brief, lay provider delivered group psychological intervention (Group Problem Management Plus; gPM+) on the mental health of refugees and their children's mental health.MethodsThis single-blind, parallel, controlled trial randomised 410 adult Syrians in Azraq Refugee Camp in Jordan who screened positive for distress and impaired functioning to either five sessions of gPM+ or enhanced usual care (EUC). Primary outcomes were scores on the Hopkins Symptom Checklist-25 (HSCL-25; depression and anxiety scales) assessed at baseline, 6 weeks, 3 months and 12 months Secondary outcomes included disability, posttraumatic stress, personally identified problems, prolonged grief, prodromal psychotic symptoms, parenting behaviour and children's mental health.ResultsBetween 15 October 2019 and 2 March 2020, 204 participants were assigned to gPM + and 206 to EUC, and 307 (74.9%) were retained at 12 months. Intent-to-treat analyses indicated that although participants in gPM + had greater reductions in depression at 3 months, at 12 months there were no significant differences between treatment arms on depression (mean difference −0.9, 95% CI −3.2 to 1.3; p = 0.39) or anxiety (mean difference −1.7, 95% CI −4.8 to −1.3; p = 0.06). There were no significant differences between conditions for secondary outcomes except that participants in gPM + had greater increases in positive parenting.ConclusionsThe short-term benefits of a brief, psychological programme delivered by lay providers may not be sustained over longer time periods, and there is a need for sustainable programmes that can prolong benefits gained through gPM + .

Background The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. Methods A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acceptability. Primary analyses will be intention-to-treat. Discussion CHANGE aims to address alcohol misuse and psychological distress with male refugees in a humanitarian setting. If it is proven to be effective, it can help fill an important under-researched gap in humanitarian service delivery. Trial registration ISRCTN ISRCTN10360385. Registered on 30 January 2023.

Background Ukraine has experienced armed conflict since 2014, with significant escalation in 2022. Since then, an estimated 3.7 million people have been internally displaced. Alcohol misuse remains a substantial public health challenge in Ukraine, with high levels of psychological distress among the displaced population. The current study aims to evaluate the effectiveness and cost-effectiveness of a transdiagnostic intervention (CHANGE) to address alcohol misuse and psychological distress through problem-solving therapy and selected behavioural strategies for managing alcohol misuse. We hypothesize that CHANGE, together with enhanced usual care (EUC), will be more effective in increasing the percentage of days abstinent (PDA) than EUC alone. Methods This study is a parallel-arm, single-blind, individually randomised controlled trial across Ukraine government-controlled territories. Following informed consent, we will recruit 500 adult war-affected men, randomised 1:1 to EUC and CHANGE, or EUC alone. Inclusion criteria include elevated levels of alcohol use (between 8 and 19, inclusive, on the Alcohol Use Disorder Identification Test); psychological distress (≥ 16 on the Kessler Psychological Distress Scale) and ability to speak Ukrainian or Russian. CHANGE will be delivered over 6 weeks by 14 community-based facilitators, with outcomes assessed at 3 months post-randomisation. The primary outcome for CHANGE is the PDA from alcohol at 3 months, measured using the Timeline Follow Back. Secondary outcomes include percentage days of heavy drinking, alcohol misuse, psychological distress (depression, anxiety, and posttraumatic stress disorder), functional disability, intimate partner violence perpetration and health economics indicators at 3 months. The primary analysis will follow an intention-to-treat approach. A mixed-methods process evaluation will examine facilitator competency, recruitment, retention/completion, appropriateness, dose received, fidelity and feasibility of delivery and acceptability. Discussion CHANGE is the first intervention aiming to address alcohol misuse and psychological distress in an active conflict setting. Trial registration ISRCTN14881856. Registered on 5th of July 2024.

Psychological distress becomes more common during adolescence, yet many young people struggle to access clinic-based mental health care. Digital, self-help single-session interventions (SSIs) could extend current provision and overcome barriers to help seeking. This study aims to pilot Project Care UK, a self-compassion-focused SSI, to examine its feasibility, acceptability, and preliminary efficacy for UK adolescents aged between 13 and 18 years. We used a single-arm, within-subjects pre-post intervention program evaluation. Consenting participants completed a demographic survey and clinical measures at baseline. Self-assessments of hope, hopelessness, negative beliefs about self-compassion, and help seeking were measured immediately before and after the intervention. Acceptability and feasibility were measured after the intervention using the Program Feedback Scale and study completion metrics. Preliminary efficacy was evaluated using linear mixed-effects models. The study protocol was preregistered on the Open Science Framework before publication. Of the 813 individuals who gave consent for the study, 714 (87.8%) initiated the preintervention assessment survey, 610 (75%) initiated the intervention, 341 (41.9%) initiated the Program Feedback Scale, and 329 (40.5%) initiated the postintervention assessment survey. The sample consisted of adolescents (mean age 15.38, SD 1.58 y) who were predominantly assigned female sex at birth, were White, and were nonheterosexual. Intervention completers widely endorsed the intervention as acceptable. Significant, favorable pre- and postintervention changes were observed across all outcome measures, including increased hope (Cohen d=0.72, P<.001), decreased hopelessness (Cohen d=-0.73, P<.001), and reduced negative beliefs about self-compassion (Cohen d=-0.64, P<.001). No significant changes were observed for help-seeking intentions. Although not all participants completed the study, our findings show that recruiting adolescents in the United Kingdom is feasible; completers indicated that the intervention was acceptable, and they showed improvements in the proximal outcomes of hope, hopelessness, and beliefs about self-compassion. More extensive follow-up over time and comparator intervention analyses would allow more robust conclusions to be drawn.

Background The COVID-19 pandemic has negatively affected the mental health of international migrant workers (IMWs). IMWs experience multiple barriers to accessing mental health care. Two scalable interventions developed by the World Health Organization (WHO) were adapted to address some of these barriers: Doing What Matters in times of stress (DWM), a guided self-help web application, and Problem Management Plus (PM +), a brief facilitator-led program to enhance coping skills. This study examines whether DWM and PM + remotely delivered as a stepped-care programme (DWM/PM +) is effective and cost-effective in reducing psychological distress, among Polish migrant workers with psychological distress living in the Netherlands. Methods The stepped-care DWM/PM + intervention will be tested in a two-arm, parallel-group, randomized controlled trial (RCT) among adult Polish migrant workers with self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15.9). Participants ( n  = 212) will be randomized into either the intervention group that receives DWM/PM + with psychological first aid (PFA) and care-as-usual (enhanced care-as-usual or eCAU), or into the control group that receives PFA and eCAU-only (1:1 allocation ratio). Baseline, 1-week post-DWM (week 7), 1-week post-PM + (week 13), and follow-up (week 21) self-reported assessments will be conducted. The primary outcome is psychological distress, assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes are self-reported symptoms of depression, anxiety, posttraumatic stress disorder (PTSD), resilience, quality of life, and cost-effectiveness. In a process evaluation, stakeholders’ views on barriers and facilitators to the implementation of DWM/PM + will be evaluated. Discussion To our knowledge, this is one of the first RCTs that combines two scalable, psychosocial WHO interventions into a stepped-care programme for migrant populations. If proven to be effective, this may bridge the mental health treatment gap IMWs experience. Trial registration Dutch trial register NL9630, 20/07/2021, https://www.onderzoekmetmensen.nl/en/trial/27052

Background Worldwide, the prevalence of mental health problems in prison populations is higher than in the general population. While prisons may provide opportunities to address mental health problems, the prison setting can also include obstacles to the actual delivery of interventions, such as mental health care staff deficiencies. A brief scalable psychological intervention such as the World Health Organization’s (WHO) Problem Management Plus (PM +) intervention, which is delivered by trained non-specialists, could be valuable in addressing common mental health problems in the prison setting. The primary aim of the study is to evaluate the feasibility and acceptability of PM + , adapted for use in Dutch remand prisons. The secondary aim is to examine barriers and facilitators for scaling up the adapted version of PM + in the Dutch prison setting. Method This single-blind pilot randomised controlled trial (RCT) will compare individual PM + with care-as-usual (PM + /CAU) to CAU only. Dutch-speaking remand prisoners (18 years or older; N  = 60) who report an elevated level of psychological distress (K10 ≥ 16) will be included. The feasibility of the intervention will be reviewed using different measures such as recruitment success, intervention retention, protocol adherence, number of serious adverse events, and stakeholders' views. Participants will be assessed for self-reported anxiety, depression, self-identified problems, vulnerability for suicide and self-harm behaviour and post-traumatic stress disorder (PTSD) symptoms at baseline, one-week post-intervention and three-month follow-up. The pilot RCT will be followed by a process evaluation. For the process evaluation, stakeholders will be interviewed ( N  = 25), including 1) RCT participants, 2) PM + helpers, supervisors and trainers, 3) prison professionals, and 4) family members & friends of RCT participants. Data of the process evaluation will be analysed using reflexive thematic analysis. Discussion This pilot RCT will be the first to study the potential of WHO-developed scalable interventions aimed at reducing mental health problems within (Dutch) prisons. Results from this study could subsequently inform a potential full-powered RCT. Trial registration This trial is registered on ClinicalTrials.gov (number NCT05927987) on 13/06/2023.

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. 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+. Participants allocated to SH+ who received at least three sessions (  = 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. 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. 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.