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Introduction: Anxiety and depression have increased markedly during the COVID-19 pandemic. There is a lack of evidence-based strategies to address these mental health needs during the pandemic. Objective: We aim to conduct a proof-of-concept trial of the efficacy of a brief group-based psychological intervention delivered via videoconferencing for adults in Australia distressed by the pandemic. Methods: In this single-blind, parallel, randomised controlled trial, adults who screened positive for COVID-related psychological distress across Australia were randomly allocated to either a 6-session group-based program based on behavioural principles (n = 120) or enhanced usual care (EUC, n = 120). Primary outcome was total score on the Hospital Anxiety and Depression (HADS) anxiety and depression subscales assessed at baseline, 1 week posttreatment, 2 months (primary outcome time point), and 6 months after treatment, as well as secondary outcome measures of worry, sleep impairment, anhedonia, mood, and COVID-19-related stress. Results: Between May 20, 2020, and October 20, 2020, 240 patients were enrolled into the trial. Relative to EUC, at 2 months participants receiving intervention showed greater reduction on anxiety (mean difference, 1.4 [95% CI, 0.3 to 2.6], p = 0.01; effect size, 0.4 [95% CI, 0.1 to 0.7]) and depression (mean difference, 1.6 [95% CI, 0.4 to 2.8], p = 0.009; effect size, 0.4 [95% CI, 0.2 to 0.7]) scales. These effects were maintained at 6 months. There were also greater reductions of worry, anhedonia, COVID-19-related fears, and contamination fears. Conclusions: This trial provides initial evidence that brief group-based behavioural intervention delivered via videoconferencing results in moderate reductions in common psychological problems arising during the COVID-19 pandemic. This program may offer a viable and scalable means to mitigate the rising mental health problems during the pandemic.

Background The mental health impacts of workers within correctional settings has been of increasing focus over the past number of years. This paper outlines the study protocol for a trial that tests the efficacy of a brief resilience program, relative to a no intervention control in reducing general psychological distress and absenteeism in a cohort of correctional personnel in NSW, Australia. Methods A, parallel, randomized controlled trial will be carried out in a small group format. Following informed consent, corrective personnel within prisons across NSW will volunteer to either attend a clinician delivered resilience program on stress management skills or not (N = 600). The primary outcome will be change in psychological distress including anxiety and depression at 2-months post intervention. Secondary outcomes include help-seeking behaviours and absenteeism. Discussion This prevention focused treatment trial will assess whether a brief clinician delivered resilience program will reduce absenteeism and mitigate psychological distress in a cohort of corrective personnel within NSW, Australia. This study will yield insights into the role of a brief psychological program in mitigating the psychological distress reported by personnel in correctional settings. Trial registration This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12622000029796). Ethics and dissemination Ethics approval has been obtained from University of New South Wales Human Research Ethics Committee. Results of the trial will be submitted for publication in peer reviewed journals and findings presented at scientific conferences and to key service providers and policy makers.

Background Emergency service personnel experience elevated rates of posttraumatic stress disorder (PTSD). There are few controlled trials for PTSD in this population, and none report longer term effects of treatment. This study evaluated the benefits of cognitive behavior therapy (CBT) for PTSD in emergency service personnel who received either brief exposure (CBT-B) to trauma memories or prolonged exposure (CBT-L) 2 years following treatment. Methods One hundred emergency service personnel with PTSD were randomized to CBT-L, CBT-B, or Wait-List (WL). Following posttreatment assessment, WL participants were randomized to an active treatment. Participants randomized to CBT-L or CBT-B were assessed at baseline, posttreatment, 6-month, and 2-year follow-up. Both CBT conditions involved 12 weekly individual sessions comprising education, CBT skills building, imaginal exposure, in vivo exposure, cognitive restructuring, and relapse prevention. Reliving trauma memories occurred for 40 min per session in CBT-L and for 10 min in CBT-B. Results At the 2-year follow-up, there were no differences in PTSD severity (Clinician Administered PTSD Scale) between CBT-L and CBT-B. There were very large effect sizes for CBT-L (1.28, 95% confidence interval [CI] = 0.90-1.64) and CBT-B (1.28, 95% CI = 0.05-1.63) from baseline to 2-year follow-up. Conclusions This study highlights that CBT can be an effective treatment of PTSD in emergency service personnel using either prolonged or brief periods of reliving the trauma memory, and that these benefits can last for at least 2 years after treatment.

Background Globally COVID-19 has had a profound impact on the psychological wellbeing of millions of people, and there is an urgent imperative to address elevated levels of distress during the COVID-19 pandemic. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a low intensity psychological intervention for adults experiencing psychological distress. This paper outlines the study protocol for a trial that tests the effectiveness of an adapted version of PM+ to reduce distress associated with COVID-19. Methods A single-blind, parallel, randomized controlled trial will be carried out for distressed people across Australia. via video conferencing on a small group basis. Following informed consent, adults that screen positive for levels of psychological distress (General Health Questionnaire-12 (GHQ-12 score ≥ 3) and have access to videoconferencing platform will be randomised to an adapted version of gPM+ (n = 120) or enhanced treatment as usual (ETAU) (n = 120). The primary outcome will be reduction in psychological distress including anxiety and depression at 2-months post treatment. Secondary outcomes include worry, sleep problems, anhedonia, social support, and stress in relation to COVID-19. Discussion The trial aims assess whether an adapted version of videoconferencing PM+ that is specifically designed to target COVI-19 related distress will result in reduced distress relative to enhanced usual care. Trial registration This trial was prospectively registered on the ANZCTR on 14/4/20 (ACTRN12620000468921).

Although exposure therapy is central in most front-line psychotherapies of post-traumatic stress disorder (PTSD), many patients do not respond to this treatment. We aimed to investigate the effects of brief aerobic exercise on the efficacy of exposure therapy in reducing the severity of PTSD.We did a single-blind, parallel, randomised controlled trial in Sydney, NSW, Australia. We included adults (aged ≥18 years) with clinician-diagnosed PTSD. We excluded participants aged 70 years or older, with imminent suicidal risk (reporting suicidal plan), presence of psychosis or substance dependence, history of moderate-to-severe traumatic brain injury, or presence of a physical disorder or impairment that might be exacerbated by aerobic exercise (eg, back pain). We randomly assigned participants (1:1) to nine 90-min weekly sessions of exposure therapy for PTSD with 10 min aerobic exercise or to the control group of exposure therapy with 10 min passive stretching. The primary outcome was PTSD severity measured by the clinician-administered PTSD scale 2 (CAPS-2), independently assessed at baseline, 1 week after treatment, and 6 months after treatment (primary outcome timepoint).Between Dec 12, 2012, and July 25, 2018, we enrolled 130 participants with PTSD, with 65 (50%) participants randomly assigned to exposure therapy with exercise and 65 (50%) to exposure therapy with passive stretching, including 79 (61%) women and 51 (39%) men, with a mean age of 39·1 years (SD 14·4; range 18-69). 99 (76%) participants were White, 14 (11%) were Asian, and 17 (13%) were listed as other. At the 6-month follow-up assessment, participants in the exposure therapy with exercise group showed greater reductions in CAPS-2 scores relative to those in the exposure therapy with stretching group (mean difference 12·1 [95% CI 2·4-21·8]; p=0·023), which resulted in a moderate effect size of 0·6 (0·1-1·1). No adverse events associated with the intervention were reported. The trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry, ACTRN12612000185864.Brief aerobic exercise has the potential to augment long-term gains of exposure therapy for PTSD, which accords with evidence from studies in animals and humans on the role of exercise in modulating the extinction learning processes. This strategy might offer a simple and affordable means to augment treatment gains for exposure therapy in people with PTSD.Australian National Health and Medical Research Council.

Background In many low resource settings, the provision of government mental health care services is limited to specialized psychiatry units in urban hospital care facilities, where the most common treatment for common mental disorders (CMDs) is pharmacotherapy, occasionally with adjunct nonspecific psychological support. We aimed to evaluate the effectiveness of adding a low intensity, psychological intervention, Problem Management Plus (PM+) for CMDs into routine care in a specialized mental health care facility in Pakistan. Methods A two arm, single-blind individual randomized controlled trial (RCT) was carried out with adults (N = 192), referred for psychological support by psychiatrists. The study participants were randomized (1:1) to PM + plus Treatment as Usual (TAU) (n = 96) or TAU only (n = 96). The primary outcomes were symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS) and functional impairment as measured by WHO Disability Assessment Schedule (WHODAS 2.0) at 20 weeks after baseline. Results The analysis was done on intention-to-treat principle. The linear mixed model analysis showed that at 20 weeks after baseline, there was a significant reduction in symptoms of anxiety and depression (mean [SD], 16.23 [8.81] vs 19.79 [7.77]; AMD, − 3.10; 95% CI, − 0.26 to − 5.76); p = 0.03 and improvement in functioning (mean [SD], 22.94 [9.37] vs 27.37 [8.36]; AMD, − 4.35; 95% CI, − 1.45 to − 7.24); p = 0.004 in PM + plus TAU versus TAU arm. The follow-up rate was 67% at primary end-point. Conclusions Specialized care facilities in LMICs may consider adding brief, evidence-based psychological treatments for CMDs to their routine care. Trial Registration Australian New Zealand Clinical Trials Registry, ACTRN12616000381482. Registered March 23, 2016. Retrospectively registered, https://www.anzctr.org.au/Default.aspx/ ACTRN12616000381482

Health care should be informed by the physical, socioeconomic, mental, and emotional well-being of the person, and account for social circumstances and culture. Patient-generated outcome measures can contribute positively to mental health research in culturally diverse populations. In this study, we analysed qualitative responses to the Psychological Outcome Profiles (PSYCHLOPS) Questionnaire—a patient-generated outcome measure based on open-ended questions, and compared the qualitative responses gathered to conventional, nomothetic measures used alongside the PSYCHLOPS in two studies. Data were collected as part of outcome research on a psychological intervention in Pakistan ( N = 346) and Kenya ( N = 521). Two researchers coded the qualitative responses to the PSYCHLOPS and identified overarching themes. We compared the overarching themes identified to the items in the conventional, nomothetic outcome measures to investigate conceptual equivalence. Using the PSYCHLOPS, the most frequently reported problems in Kenya were financial constraints, poor health, and unemployment. In Pakistan, the most frequent problems were poor health and emotional problems. Most of the person-generated problem concepts were covered also in nomothetic measures that were part of the same study. However, there was no item equivalence in the nomothetic measures for the most frequent PSYCHLOPS problem cited in both countries. Response bias and measurement bias may not be excluded. More research on the use of PSYCHLOPS alongside conventional outcome measures is needed to further explore the extent to which it may bring added value. Use of a PSYCHLOPS semistructured interview schedule and efforts to minimise response biases should be considered.

Background: Health care workers (HCWs) typically face high work demands, which can be exacerbated during crises such as the COVID-19 pandemic. These demands may result in high psychological distress and reduced work performance. Although there are psychological interventions to reduce stress in HCWs under normal working circumstances, no intervention have been specifically developed to addresses stress in the context of public health crises such as the current COVID-19 pandemic. This study aims to evaluate the effectiveness of RECHARGE, a psychological intervention specifically developed for HCWs to reduce distress in HCWs. It is based on a brief crisis intervention of the World Health Organization that teaches basic stress management skills from cognitive behavioural therapy. Methods: A randomized controlled trial (RCT) will be carried out among 160 physicians, nurses, and other HCWs working in hospitals in Switzerland during COVID-19, who are at least moderately distressed. HCWs will be randomised to RECHARGE (n=80) or active treatment as usual (ATAU) (n=80). Pre-intervention (week 1, T1), post-intervention (week 4, T2) and 2-month follow-up (week 12, T3) assessments include psychological distress as primary outcome, and indicators of mental ill-being (worries, anxiety, depression, burnout, traumatic stress, distress due to perceived ethical dilemma) and work performance as secondary outcomes. These outcomes will be compared between HCWs in the RECHARGE and ATAU groups. Discussion: RECHARGE is an evidence-informed brief, flexible, easily scalable, fully online psychological program that allows delivery in pandemic conditions, including social isolation. Therefore, this program can serve as a much-needed template for an intervention to reduce stress and enhance work performance in HCWs during the COVID-19 pandemic. If proven effective, RECHARGE may not only be used to reduce elevated stress in HCWs in Switzerland, but also globally. Key words: COVID-19, randomised controlled trial, protocol, health care workers; psychological treatment; distress, crisis intervention; pandemic; resilience

Background Because of the high burden of untreated mental illness in humanitarian settings and low- and middle-income countries, scaling-up effective psychological interventions require a cultural adaptation process that is feasible and acceptable. Our adaptation process incorporates changes into both content and implementation strategies, with a focus on local understandings of distress and treatment mechanisms of action. Methods Building upon the ecological validity model, we developed a 10-step process, the mental health Cultural Adaptation and Contextualization for Implementation (mhCACI) procedure, and piloted this approach in Nepal for Group Problem Management Plus (PM+), a task-sharing intervention, proven effective for adults with psychological distress in low-resource settings. Detailed documentation tools were used to ensure rigor and transparency during the adaptation process. Findings The mhCACI is a 10-step process: (1) identify mechanisms of action, (2) conduct a literature desk review for the culture and context, (3) conduct a training-of-trainers, (4) translate intervention materials, (5) conduct an expert read-through of the materials, (6) qualitative assessment of intervention population and site, (7) conduct practice rounds, (8) conduct an adaptation workshop with experts and implementers, (9) pilot test the training, supervision, and implementation, and (10) review through process evaluation. For Group PM+, key adaptations were harmonizing the mechanisms of action with cultural models of ‘tension’; modification of recruitment procedures to assure fit; and development of a skills checklist. Conclusion A 10-step mhCACI process could feasibly be implemented in a humanitarian setting to rapidly prepare a psychological intervention for widespread implementation.

Background Refugee youth experience hardships associated with exposure to trauma in their homelands and during and after displacement, which results in higher rates of common mental disorders. The World Health Organization (WHO) developed Problem Management Plus (PM+), a non-specialist-delivered brief psychological intervention, for individuals who have faced adversity. PM+ comprises problem-solving, stress management, behavioural activation and strengthening social support. However, it does not include an emotional processing component, which is indicated in trauma-exposed populations. Objective This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and acceptability of PM+, adapted to Syrian, Eritrean and Iraqi refugee youth residing in the Netherlands, with and without a newly developed Emotional Processing (EP) Module. Methods Refugee youth (N = 90) between 16 and 25 years of age will be randomized into PM+ with care-as-usual (CAU), (n = 30), PM+ with Emotional Processing (PM+EP) with CAU (n = 30) or CAU only (n = 30). Inclusion criteria are self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15) and impaired daily functioning (WHO Disability Assessment Schedule; WHODAS 2.0 > 16). Participants will be assessed at baseline, one-week post-intervention and three-month follow-up. The main outcome is the feasibility and acceptability of the adapted PM+ and PM+EP. The secondary outcomes are self-reported psychological distress, functional impairment, post-traumatic stress disorder (PTSD) symptom severity and diagnosis, social support, and self-identified problems. The pilot RCT will be succeeded by a process evaluation including trial participants, participants’ significant others, helpers, and mental health professionals (n = 20) to evaluate their experiences with the PM+ and PM+EP programmes. Results and Conclusion This is the first study that evaluates the feasibility of PM+ for this age range with an emotional processing module integrated. The results may inform larger RCTs and implementation of PM+ interventions among refugee youth. Trial Registration Registered to Dutch Trial Registry, NL8750, on 3 July 2020. Medical Ethical Committee of the Amsterdam University Medical Centre, location Vrije Universiteit Medical Centre, Protocol ID: 2020.224, 1 July 2020., HIGHLIGHTS This protocol describes a feasibility study in which an adapted version of Problem Management Plus (PM+) with an Emotional Processing module is evaluated for refugee youth.The findings will also indicate the feasibility of training non-specialists to deliver this intervention.

Background Most refugees are less than 18 years and at heightened risk of common mental disorders (CMDs) relative to other youth. Limited evidence exists for psychosocial programsfor youth in low-resource settings. Early Adolescent Skills for Emotions (EASE) was developed by the World Health Organization to address this gap. Objectives This study tested the safety, feasibility, and trial procedures of the EASE intervention among Syrian refugee youth in preparation for a definitive randomized controlled trial (RCT). Methods A feasibility RCT was conducted in Amman, Jordan with Syrian children aged 10–14 years who reported psychological distress. Following community screening, youth and their caregivers were randomized to receive either the EASE intervention or enhanced treatment as usual (ETAU). EASE comprised seven group sessions teaching children coping skills, and caregivers received three group sessions to augment the youth sessions. Assessments were conducted at baseline and 1 week following the last EASE session (8 weeks following baseline). Following the trial, a qualitative process evaluation with staff and beneficiaries took place. Primary outcomes were safety and feasibility indicators, and distress was measured by the Paediatric Symptom Checklist. Results In November 2018, 179 children were screened; 61 (33%) met criteria for distress (34.1%), two were excluded for suicidal risk, and 59 were randomized (EASE = 33, ETAU = 26). Of those who received EASE, 26 children (79%) completed the intervention. Group attendance was high and no adverse events were reported in either arm. Psychological distress did not show signs of abating in either group over time. Conclusion This feasibility trial demonstrated the safety and acceptability of the intervention. Important lessons were learnt regarding entry criteria into the study and engagement of caregivers in the intervention. A fully powered randomized controlled trial will be conducted to evaluate the efficacy of EASE., HIGHLIGHTS Feasibility trial of group psychological intervention (GroupPM+) in a Syrian refugee camp in Jordan. Sixty-four participants randomized; safety and cultural acceptance was observed. Positive results support the readiness for a definitive RCT to test effectiveness and cost-effectiveness.

Background Globally, 235 million people are impacted by humanitarian emergencies worldwide, presenting increased risk of experiencing a mental disorder. Our objective was to test the effectiveness of a brief group psychological treatment delivered by trained facilitators without prior professional mental health training in a disaster-prone setting. Methods and findings We conducted a cluster randomized controlled trial (cRCT) from November 25, 2018 through September 30, 2019. Participants in both arms were assessed at baseline, midline (7 weeks post-baseline, which was approximately 1 week after treatment in the experimental arm), and endline (20 weeks post-baseline, which was approximately 3 months posttreatment). The intervention was Group Problem Management Plus (PM+), a psychological treatment of 5 weekly sessions, which was compared with enhanced usual care (EUC) consisting of a family psychoeducation meeting with a referral option to primary care providers trained in mental healthcare. The setting was 72 wards (geographic unit of clustering) in eastern Nepal, with 1 PM+ group per ward in the treatment arm. Wards were eligible if they were in disaster-prone regions and residents spoke Nepali. Wards were assigned to study arms based on covariate constrained randomization. Eligible participants were adult women and men 18 years of age and older who met screening criteria for psychological distress and functional impairment. Outcomes were measured at the participant level, with assessors blinded to group assignment. The primary outcome was psychological distress assessed with the General Health Questionnaire (GHQ-12). Secondary outcomes included depression symptoms, posttraumatic stress disorder (PTSD) symptoms, “heart–mind” problems, social support, somatic symptoms, and functional impairment. The hypothesized mediator was skill use aligned with the treatment’s mechanisms of action. A total of 324 participants were enrolled in the control arm (36 wards) and 319 in the Group PM+ arm (36 wards). The overall sample (N = 611) had a median age of 45 years (range 18–91 years), 82% of participants were female, 50% had recently experienced a natural disaster, and 31% had a chronic physical illness. Endline assessments were completed by 302 participants in the control arm (36 wards) and 303 participants in the Group PM+ arm (36 wards). At the midline assessment (immediately after Group PM+ in the experimental arm), mean GHQ-12 total score was 2.7 units lower in Group PM+ compared to control (95% CI: 1.7, 3.7, p < 0.001), with standardized mean difference (SMD) of −0.4 (95% CI: −0.5, −0.2). At 3 months posttreatment (primary endpoint), mean GHQ-12 total score was 1.4 units lower in Group PM+ compared to control (95% CI: 0.3, 2.5, p = 0.014), with SMD of −0.2 (95% CI: −0.4, 0.0). Among the secondary outcomes, Group PM+ was associated with endline with a larger proportion attaining more than 50% reduction in depression symptoms (29.9% of Group PM+ arm versus 17.3% of control arm, risk ratio = 1.7, 95% CI: 1.2, 2.4, p = 0.002). Fewer participants in the Group PM+ arm continued to have “heart–mind” problems at endline (58.8%) compared to the control arm (69.4%), risk ratio = 0.8 (95% CI, 0.7, 1.0, p = 0.042). Group PM+ was not associated with lower PTSD symptoms or functional impairment. Use of psychosocial skills at midline was estimated to explain 31% of the PM+ effect on endline GHQ-12 scores. Adverse events in the control arm included 1 suicide death and 1 reportable incidence of domestic violence; in the Group PM+ arm, there was 1 death due to physical illness. Study limitations include lack of power to evaluate gender-specific effects, lack of long-term outcomes (e.g., 12 months posttreatment), and lack of cost-effectiveness information. Conclusions In this study, we found that a 5-session group psychological treatment delivered by nonspecialists modestly reduced psychological distress and depression symptoms in a setting prone to humanitarian emergencies. Benefits were partly explained by the degree of psychosocial skill use in daily life. To improve the treatment benefit, future implementation should focus on approaches to enhance skill use by PM+ participants. Trial registration ClinicalTrials.gov NCT03747055., Mark Jordans and co-workers evaluate a group therapy intervention in adults affected by psychological distress in Nepal., Author summary Why was this study done? Millions of people worldwide are affected by humanitarian emergencies such as war, environmental disasters, and pandemics. Most populations in these settings lack access to mental health services. In prior studies, people who are not mental health specialists have been trained to effectively deliver psychological treatments, including Problem Management Plus (PM+), which is a brief 5-session intervention. However, there has only been one prior study of a group-based format of PM+ delivered by nonspecialists. As the use of nonspecialists increases, there are new questions about how these psychological interventions work when delivered by someone who is not a mental health professional. Studying potential mechanisms of action (i.e., how the intervention works) could be instrumental to increasing effectiveness when scaling up. What did the researchers do and find? The researchers evaluated the effectiveness of Group PM+ in a setting prone to humanitarian emergencies with delivery of the intervention by briefly trained nonspecialists, and the researchers evaluated a potential mechanism of action involved in reducing psychological distress. Adults who received Group PM+ delivered by nonspecialists in their communities showed greater reduction in psychological distress at 3 months after the intervention compared to adults who had been offered referral options for services. At 3 months after the intervention, approximately 1 out of 3 adults in Group PM+ had a 50% reduction in depression symptoms compared to 1 out of 6 who were in the control arm receiving referral options for services. Regarding how the intervention produced changes, a third of the differences between study arms was explained by participants’ use of psychosocial skills taught in Group PM+, such as breathing exercises, problem-solving techniques, and seeking social support. What do these findings mean? In humanitarian emergencies with a lack of mental health specialists, a 5-session group psychological treatment delivered by nonspecialists can be used to modestly reduce psychological distress and depression symptoms. The benefits of Group PM+ are partly explained by the degree of psychosocial skill use being promoted through the intervention. Therefore, future use of the intervention should explore how to enhance practice of these skills in daily life. Further research is needed to evaluate how the impact of Group PM+ differs by gender because the study points toward potentially less benefit among men compared to women.

Background Common mental health problems are prevalent among refugee minors and impair their daily functioning. Due to various barriers such as lack of culturally appropriate treatments, waiting lists, and stigma they have limited access to care. Problem Management Plus (PM+) was developed by the World Health Organization to address these barriers. PM+ is transdiagnostic, delivered by non-professional helpers, and consists of 5 sessions of problem-solving skills, behavioural activation and stress management. PM+ is effective in reducing adults' distress and improve functioning. We aimed to adapt PM+ for refugee minors and add an emotional processing module to target symptoms of posttraumatic stress disorder. Methods We culturally and contextually adapted PM+ for use in Syrian, Eritrean and Afghan refugee minors (age 16-18 years). Data were collected through: 1) free list interviews with Syrian, Eritrean and Afghan refugee minors (n = 30), 2) key informant interviews with knowledgeable refugees (n = 6), professionals (n = 6), policy makers (n = 6) and 3) focus group discussions (n = 24). Data were analysed in ATLAS.ti through inductive and deductive framework analysis. Results The interviews with youth revealed daily life problems around the following themes: language, family and peers, and substance use. The overall results suggested the need for culture- and age-specific adaptations of 1) the PM+ manual content (language, metaphors, illustrations) and 2) intervention delivery (modality, content and presentation of the trauma processing module, and duration). Conclusions This study led to specific adaptations of PM+ for refugee adolescents to be used in two randomized controlled trials in the Netherlands and Sweden. Key message Refugee minors face numerous barriers reaching mental health care. Scalable, culturally adapted psychological interventions should be developed and evaluated to address common mental disorders in refugee youth.

Background Innovative interventions to address mental health needs in low- and middle-income countries (LMICs) have increased. Before implementation, it is important to culturally adapt these interventions. There is a pressing need for a systematic approach that is feasible in settings with resource constraints, to guide not only content modification but also implementation elements to inform scalability and quality assurance. We harmonized existing guidance in cultural adaptation to develop a transparent framework for rapid and systematic cultural adaptations. We piloted this approach in Nepal for Group Problem Management Plus (PM+), a trans-diagnostic, task sharing intervention, for adults with psychological distress in humanitarian settings. Methods Building upon the ecological validity model, a 10-step process was used to adapt the Group PM + intervention in preparation for a feasibility trial in Nepal. A process evaluation was conducted after the trial to gather feedback on the adaptations. Detailed documentation tools were used to ensure rigor during the adaptation process. Findings The complete adaptation included a 10-step process; 1) Identify mechanisms of action, 2) Conduct a literature desk review for the culture and context, 3) Conduct a Training of Trainers (ToT), 4) Translate intervention materials, 5) Conduct an expert read-through of the materials, 6) Qualitative assessment of intervention population and site, 7) Conduct practice rounds, 8) Conduct an adaptation workshop with experts and implementers, 9) Pilot test the training, supervision, and implementation, and 10) Review through process evaluation. An iterative process with rapid modification of content and procedures was necessary. For Group PM+, key adaptations were harmonizing the mechanisms of action with cultural models of distress; modification of recruitment procedures to assure fit between cultural models of distress and population; and development of a skills checklist to monitor facilitator engagement with mechanisms of action. Conclusion A 10-step cultural adaptation process could feasibly be implemented in a humanitarian setting to rapidly prepare a psychological intervention for widespread implementation. Having a standard systematic approach will help develop a body of literature and lessons to facilitate the process for greater cultural appropriateness and effectiveness of psychological interventions worldwide.

Background:Problem Management Plus (PM+) is a brief multicomponent intervention incorporating behavioral strategies delivered by lay health workers. The effectiveness of PM+ has been evaluated in randomized controlled trials in Kenya and Pakistan. When developing interventions for large-scale implementation it is considered essential to evaluate their feasibility and acceptability in addition to their efficacy. This paper discusses a qualitative evaluation of PM+ for women affected by adversity in Kenya.Methods:Qualitative interviews were conducted with 27 key informants from peri-urban Nairobi, Kenya, where PM+ was tested. Interview participants included six women who completed PM+, six community health volunteers (CHVs) who delivered the intervention, seven people with local decision making power, and eight project staff involved in the PM+ trial.Results:Key informants generally noted positive experiences with PM+. Participants and CHVs reported the positive impact PM+ had made on their lives. Nonetheless, potential structural and psychological barriers to scale up were identified. The sustainability of CHVs as unsalaried, volunteer providers was mentioned by most interviewees as the main barrier to scaling up the intervention.Conclusions:The findings across diverse stakeholders show that PM+ is largely acceptable in this Kenyan setting. The results indicated that when further implemented, PM+ could be of great value to people in communities exposed to adversities such as interpersonal violence and chronic poverty. Barriers to large-scale implementation were identified, of which the sustainability of the non-specialist health workforce was the most important one.

Armed conflict leads to increased risk of emotional distress among children and adolescents, and increased exposure to significant daily stressors such as poverty and community and family violence. Unfortunately, these increased risks usually occur in the context of largely unavailable mental health services. There is growing empirical support that evidence-based treatment techniques can be adapted and delivered by non-specialists with high fidelity and effectiveness. However, in order to improve feasibility, applicability, and outcomes, appropriate cultural and contextual adaptation is essential when delivering in different settings and cultures. This paper reports the adaptation process conducted on a new World Health Organization psychological intervention—Early Adolescent Skills for Emotions (EASE)—for use in the north of Lebanon. Lebanon is a middle-income country that hosts the largest number of refugees per capita globally. We conducted: i) a scoping review of literature on mental health in Lebanon, with a focus on Syrian refugees; ii) a rapid qualitative assessment with adolescents, caregivers, community members, and health professionals; iii) cognitive interviews regarding the applicability of EASE materials; iv) a psychologist review to reach optimal and consistent Arabic translation of key terms; v) “mock sessions” of the intervention with field staff and clinical psychology experts; vi) gathering feedback from the Training of Trainers workshop, and subsequent implementation of practice sessions; and vii) gathering feedback from the Training of Facilitators workshop, and subsequent implementation of practice sessions. Several changes were implemented to the materials—some were Lebanon-specific cultural adaptations, while others were incorporated into original materials as they were considered relevant for all contexts of adversity. Overall, our experience with adaptation of the EASE program in Lebanon is promising and indicates the acceptability and feasibility of a brief, non-specialist delivered intervention for adolescents and caregivers. The study informs the wider field of global mental health in terms of opportunities and challenges of adapting and implementing low-intensity psychological interventions in settings of low resources and high adversity.

BACKGROUND\ud \ud 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.\ud \ud METHODS\ud \ud 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.\ud \ud FINDINGS\ud \ud 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.\ud \ud INTERPRETATION\ud \ud 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.\ud \ud FUNDING\ud \ud WHO through a grant from the Office for Foreign Disaster Assistance.

Background Women affected by adversity, including gender-based violence, are at increased risk for developing common mental disorders such as depression, anxiety and posttraumatic stress disorder (PTSD). The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, that can be delivered by non-specialist counsellors that addresses common mental disorders in people affected by adversity. The objectives of this study are to evaluate effectiveness of PM+ among women who have been affected by adversity, including gender-based violence, and to perform a process evaluation. Methods Informed by community consultations, the PM+ manual has been translated and adapted to the local context. A randomized controlled trial will be carried out in the catchment areas of three local health care facilities in Dagoretti Sub County, Nairobi. After informed consent, females with high psychological distress (General Health Questionnaire-12 (score >2) and functional impairment (WHO Disability Assessment Schedule 2.0 score >16) will be randomised to PM+ (n = 247) or enhanced treatment as usual (n = 247). Post-treatment and 3-months post-treatment follow-up assessments include psychological distress, functional disability, PTSD symptoms, perceived problems for which the person seeks help, health care use and health costs. For evaluating the process of implementing PM+ within local communities in Nairobi 20 key informant interviews will be carried out in participants, PM+ providers, decision makers, clinical staff. Discussion If PM+ is proven effective, it will be rolled out to other low and middle income areas and other populations for further adaptation and testing. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616000032459. Registered prospectively on January 18, 2016

Aims:The aim of this feasibility trial was to evaluate the feasibility and acceptability of the locally adapted Group Problem Management Plus (PM+) intervention for women in the conflict affected settings in Swat, Pakistan.Methods:This mixed-methods study incorporated a quantitative component consisting of a two arm cluster randomised controlled feasibility trial, and qualitative evaluation of the acceptability of the Group PM+ to a range of stakeholder groups. For the quantitative component, on average from each of the 20 Lady Health Workers (LHWs) catchment area (20 clusters), six women were screened and recruited for the trial with score of >2 on the General Health Questionnaire and score of >16 on the WHO Disability Assessment Schedule. These LHW clusters were randomised on a 1 : 1 allocation ratio using a computer-based software through a simple randomisation method to the Group PM+ intervention or Enhanced Usual Care. The Group PM+ intervention consisted of five weekly sessions of 2 h duration delivered by local non-specialist females under supervision. The primary outcome was individual psychological distress, measured by levels of anxiety and depression on the Hospital Anxiety and Depression Scale at 7th week after baseline. Secondary outcomes include symptoms of depression, post-traumatic stress disorder (PTSD), general psychological profile, levels of functioning and generalised psychological distress. Intervention acceptability was explored through in-depth interviews.Results:The results show that lay-helpers with no prior mental health experience can be trained to achieve the desired competency to successfully deliver the intervention in community settings under supervision. There was a good intervention uptake, with Group PM+ considered useful by participants, their families and lay-helpers. The outcome evaluation, which was not based on a large enough study to identify statistically significant results, indicated statistically significant improvements in depression, anxiety, general psychological profile and functioning. The PTSD symptoms and depressive disorder scores showed a trend in favour of the intervention.Conclusion:This trial showed robust acceptance in the local settings with delivery by non-specialists under supervision by local trained females. The trial paves the way for further adaptation and exploration of the outcomes through larger-scale implementation and definitive randomised controlled trials in the local settings.

In humanitarian settings common mental disorders (depression, anxiety disorders, posttraumatic stress disorder) are highly prevalent. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, delivered by paraprofessionals that addresses common mental disorders in people in communities affected by adversity. The objectives of this study are to test effectiveness and cost-effectiveness of the locally adapted PM+ compared to Treatment as usual (TAU) in Peshawar District, Pakistan.A randomised controlled trial will be conducted in 346 primary care attendees in 3 health care centres in Peshawar District, Pakistan. After informed consent, primary care attendees with high levels of psychological distress according to the General Health Questionnaire-12 (GHQ-12) and functional impairment (WHO Disability Assessment Schedule 2.0 (WHODAS)) will be assigned to PM+ (n = 173) or TAU (n = 173). At baseline, 1 week and 3 months following PM+, independent assessors will assess psychological distress with the Hospital Anxiety and Depression Scale (HADS), and functional disability with the WHODAS. Secondary outcomes are posttraumatic stress disorder (PTSD) symptoms, and client-perceived priority problems. Further, cost-effectiveness will be assessed using the Service Receipt Inventory (SRI).If proven effective, PM+ will be rolled out to other areas for further adaptation and testing in diverse humanitarian settings.ACTRN12614001235695. Registered 26 November 2014. Australian New Zealand Clinical Trials Registry.

BackgroundAlthough emergency service personnel experience markedly elevated the rates of post-traumatic stress disorder (PTSD), there are no rigorously conducted trials for PTSD in this population. This study assessed the efficacy of cognitive behaviour therapy (CBT) for PTSD in emergency service personnel, and examined if brief exposure (CBT-B) to trauma memories is no less efficacious as prolonged exposure (CBT-L).MethodOne hundred emergency service personnel with PTSD were randomised to either immediate CBT-L, CBT-B or wait-list (WL). Following post-treatment assessment, WL participants were randomised to an active treatment. Participants randomised to CBT-L or CBT-B were assessed at baseline, post-treatment and at 6-month follow-up. Both CBT conditions involved 12 weekly individual sessions comprising education, CBT skills building, imaginal exposure, in vivo exposure, cognitive restructuring and relapse prevention. Imaginal exposure occurred for 40 min per session in CBT-L and for 10 min in CBT-B.ResultsAt post-treatment, participants in WL had smaller reductions in PTSD severity (Clinician Administered PTSD Scale), depression, maladaptive appraisals about oneself and the world, and smaller improvements on psychological and social quality of life than CBT-L and CBT-B. There were no differences between CBT-L and CBT-B at follow-up on primary or secondary outcome measures but both CBT-L and CBT-B had large baseline to follow-up effect sizes for reduction of PTSD symptoms.ConclusionsThis study highlights that CBT, which can include either long or brief imaginal exposure, is efficacious in reducing PTSD in emergency service personnel.

With the increased recognition of mental health as part of global health agendas, the substantial gap between mental health needs and access to evidence-based treatment services in low- and middle-income countries (LMICs) has been exposed. More than 80% of the world’s population reside in these lower resource settings where exposure to adverse living conditions and mass trauma is widespread. However, less than 20% of mental health resources are managed by LMICs. Evidence-informed psychological and psychosocial interventions that have been adapted for trauma-affected LMICs and can be delivered by non-specialist providers offer one solution to filling this treatment gap. While the evidence for these low-intensity interventions is mounting, many challenges remain that impinge on the effective implementation of such interventions in these settings. These include the selection of delivery agents, the duration and methods of training and supervision, and challenges related to implementation and local government ownership. This chapter examines the current literature on low-intensity interventions in LMICs and provides a brief commentary on the existing challenges to implementation.

The crisis in Syria has resulted in vast numbers of refugees seeking asylum in Syria's neighbouring countries as well as in Europe. Refugees are at considerable risk of developing common mental disorders, including depression, anxiety, and posttraumatic stress disorder (PTSD). Most refugees do not have access to mental health services for these problems because of multiple barriers in national and refugee specific health systems, including limited availability of mental health professionals. To counter some of challenges arising from limited mental health system capacity the World Health Organization (WHO) has developed a range of scalable psychological interventions aimed at reducing psychological distress and improving functioning in people living in communities affected by adversity. These interventions, including Problem Management Plus (PM+) and its variants, are intended to be delivered through individual or group face-to-face or smartphone formats by lay, non-professional people who have not received specialized mental health training, We provide an evidence-based rationale for the use of the scalable PM+ oriented programmes being adapted for Syrian refugees and provide information on the newly launched STRENGTHS programme for adapting, testing and scaling up of PM+ in various modalities in both neighbouring and European countries hosting Syrian refugees.La crisis en Siria ha dado lugar a un gran número de refugiados que buscan asilo en países vecinos a Siria, así como en Europa. Los refugiados corren un riesgo considerable de desarrollar trastornos mentales comunes, como depresión, ansiedad y trastorno por estrés postraumático (TEPT). La mayoría de los refugiados no tienen acceso a servicios de salud mental para estos problemas debido a las múltiples barreras existentes en los sistemas de salud nacionales y específicos para refugiados, incluida una limitada disponibilidad de profesionales de salud mental. Para contrarrestar algunos de los retos derivados de la limitada capacidad del sistema de salud mental, la Organización Mundial de la Salud (OMS) ha desarrollado una gama de intervenciones psicológicas escalables dirigidas a reducir la angustia psicológica y mejorar el funcionamiento de las personas afectadas por la adversidad. Estas intervenciones, que incluyen叙利亚危机导致了海量的难民到周边国家和欧洲寻求避难所。难民们发展出常见心理障碍的风险非常大，其中包括抑郁，焦虑，创伤后应激障碍（PTSD）。大多数难民没有渠道向心理健康机构寻求帮助，这主要是因为国家医疗和难民健康系统的种种阻碍，包括心理健康专家的数量不足。为了应对心理健康系统容量有限所产生的问题，世界卫生组织（WHO）发展出了一系列的可量化心理干预方法，用来减少心理障碍和提高社区中处于逆境里的人们的生活功能。这些干预方法中就有《问题应对量表Plus》（PM+）和它的其他变型，用来给未经过专业心理健康训练的非专业新手以面对面的或智能手机的形式向个人或群体使用。我们为针对叙利亚难民改良的可量化的PM+为基础的项目提供了有证据支持的原理，并且提供了关于新近运行的STRENGTHS项目的信息，该项目旨在在接受叙利亚难民的周边国家和欧洲国家中适应、测试、扩大PM+的多种形式。.

Objective: To evaluate the relative efficacies of trauma-focused cognitive behavior therapy and problem-solving therapy in treating post-traumatic stress disorder in children affected by civil conflict in Aceh, Indonesia. Method: A controlled trial of children with post-traumatic stress disorder ( N = 64) randomized children to either five individual weekly sessions of trauma-focused cognitive behavior therapy or problem-solving therapy provided by lay-counselors who were provided with brief training. Children were assessed by blind independent assessors at pretreatment, posttreatment and 3-month follow-up on post-traumatic stress disorder, depression and anger, as well as caregiver ratings of the child’s post-traumatic stress disorder levels. Results: Intent-to-treat analyses indicated no significant linear time × treatment condition interaction effects for post-traumatic stress disorder at follow-up ( t(129.05) = −0.55, p = 0.58), indicating the two conditions did not differ. Across both conditions, there were significant reductions in post-traumatic stress disorder on self-reported ( t(131.26) = −9.26, p < 0.001) and caregiver-reported ( t(170.65) = 3.53, p = 0.001) measures and anger ( t(127.66) = −7.14, p < 0.001). Across both conditions, there was a large effect size for self-reported post-traumatic stress disorder (cognitive behavior therapy: 3.73, 95% confidence interval = [2.75, 3.97]; problem-solving: 2.68, 95% confidence interval = [2.07, 3.29]). Conclusions: These findings suggest that trauma-focused cognitive behavior therapy and problem-solving approaches are comparably successful in reducing post-traumatic stress disorder and anger in treating mental health in children in a post-conflict setting. This pattern may reflect the benefits of non-specific therapy effects or gains associated with trauma-focused or problem-solving approaches.

Importance \ud The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed.\ud \ud Objective \ud To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings.\ud \ud Design, Setting, and Participants \ud A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).\ud \ud Interventions \ud Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care.\ud \ud Main Outcomes and Measures \ud Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire).\ud \ud Results \ud Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, −0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, −0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower mean (SD) HADS scores than the control group for anxiety (7.25 [3.63] vs 10.03 [3.87]; AMD, −2.77; 95% CI, −3.56 to −1.98) and depression (6.30 [3.40] vs 9.27 [3.56]; AMD, −2.98; 95% CI, −3.74 to −2.22). At 3 months, there were also significant differences in scores of posttraumatic stress (AMD, −5.86; 95% CI, −8.53 to −3.19), functional impairment (AMD, −4.17; 95% CI, −5.84 to −2.51), problems for which the person sought help (AMD, −1.58; 95% CI, −2.40 to −0.77), and symptoms of depressive disorder (AMD, −3.41; 95% CI, −4.49 to −2.34).\ud \ud Conclusions and Relevance \ud Among adults impaired by psychological distress in a conflict-affected area, lay health worker administration of a brief multicomponent intervention based on established behavioral strategies, compared with enhanced usual care, resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months.\ud \ud Trial Registration anzctr.org.au Identifier: ACTRN12614001235695

This study investigated the recollections of child survivors of the 2004 Asian tsunami in terms of their vantage point and posttraumatic stress disorder (PTSD) responses. Five years after the tsunami, 110 children (aged 7–13 years) living in Aceh, Indonesia were assessed for source of memories of the tsunami (personal memory or second-hand source), vantage point of the memory, and were administered the Children’s Revised Impact of Event Scale-13. Fifty-three children (48%) met criteria for PTSD. Two-thirds of children reported direct memories of the tsunami and one-third reported having memories based on reports from other people. More children (97%) who reported an indirect memory of the tsunami recalled the event from an onlooker’s perspective to some extent than those who recalled the event directly (63%). Boys were more likely to rely on stories from others to reconstruct their memory of the tsunami, and to adopt an observer perspective. Boys who adopted an observer’s perspective had less severe PTSD than those who adopted a field perspective. These findings suggest that, at least in the case of boys, an observer perspectives of trauma can be associated with levels of PTSD.

Women affected by adversity, including gender-based violence, are at increased risk for developing common mental disorders such as depression, anxiety and posttraumatic stress disorder (PTSD). The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, that can be delivered by non-specialist counsellors that addresses common mental disorders in people affected by adversity. The objectives of this study are to evaluate effectiveness of PM+ among women who have been affected by adversity, including gender-based violence, and to perform a process evaluation.Informed by community consultations, the PM+ manual has been translated and adapted to the local context. A randomized controlled trial will be carried out in the catchment areas of three local health care facilities in Dagoretti Sub County, Nairobi. After informed consent, females with high psychological distress (General Health Questionnaire-12 (score2) and functional impairment (WHO Disability Assessment Schedule 2.0 score16) will be randomised to PM+ (n = 247) or enhanced treatment as usual (n = 247). Post-treatment and 3-months post-treatment follow-up assessments include psychological distress, functional disability, PTSD symptoms, perceived problems for which the person seeks help, health care use and health costs. For evaluating the process of implementing PM+ within local communities in Nairobi 20 key informant interviews will be carried out in participants, PM+ providers, decision makers, clinical staff.If PM+ is proven effective, it will be rolled out to other low and middle income areas and other populations for further adaptation and testing. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616000032459. Registered prospectively on January 18, 2016.

Living in conditions of chronic adversity renders many women more vulnerable to experiencing gender-based violence (GBV). In addition to GBV’s physical and social consequences, the psychological effects can be pervasive. Access to evidence-based psychological interventions that seek to support the mental health of women affected by such adversity is rare in low- and middle-income countries. The current study evaluates a brief evidence-informed psychological intervention developed by the World Health Organization for adults impacted by adversity (Problem Management Plus; PM+). A feasibility randomised control trial (RCT) was conducted to inform a fully powered trial. Community health workers delivered the intervention to 70 women residing in three peri-urban settings in Nairobi, Kenya. Women, among whom 80% were survivors of GBV (N = 56), were randomised to receive five sessions of either PM+ (n = 35) by community health workers or enhanced treatment as usual (ETAU; n = 35). PM+ was not associated with any adverse events. Although the study was not powered to identify effects and accordingly did not identify effects on the primary outcome measure of general psychological distress, women survivors of adversity, including GBV, who received PM+ displayed greater reductions in posttraumatic stress disorder symptoms following treatment than those receiving ETAU. This feasibility study suggests that PM+ delivered by lay health workers is an acceptable and safe intervention to reach women experiencing common mental disorders and be inclusive for those affected by GBV and can be studied in a RCT in this setting. The study sets the stage for a fully powered, definitive controlled trial to assess this potentially effective intervention. ACTRN12614001291673 , 10/12/2014, retrospectively registered during the recruitment phase.

Objective: The aim of the current study was to examine whether neural reserve influenced the duration of post-traumatic amnesia (PTA) following mild traumatic brain injury (MTBI).Method: The relationship between duration of PTA and both IQ and education was examined in a group of 59 MTBI patients. In addition, the effects of factors that could potentially diminish neural reserve, namely pre-injury hazardous alcohol consumption, pre-injury marijuana use, previous neurological damage, age and post-injury emotional distress on PTA duration were analysed.Results: Significant, negative associations between PTA duration and both IQ and education were revealed. None of the other variables that were examined were significantly related to PTA duration.Conclusion: The findings were interpreted as providing preliminary evidence to suggest that reference to neural reserve may help explain between-subject variability in acute response to MTBI.

Background In humanitarian settings common mental disorders (depression, anxiety disorders, posttraumatic stress disorder) are highly prevalent. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, delivered by paraprofessionals that addresses common mental disorders in people in communities affected by adversity. The objectives of this study are to test effectiveness and cost-effectiveness of the locally adapted PM+ compared to Treatment as usual (TAU) in Peshawar District, Pakistan. Methods A randomised controlled trial will be conducted in 346 primary care attendees in 3 health care centres in Peshawar District, Pakistan. After informed consent, primary care attendees with high levels of psychological distress according to the General Health Questionnaire-12 (GHQ-12) and functional impairment (WHO Disability Assessment Schedule 2.0 (WHODAS)) will be assigned to PM+ (n = 173) or TAU (n = 173). At baseline, 1 week and 3 months following PM+, independent assessors will assess psychological distress with the Hospital Anxiety and Depression Scale (HADS), and functional disability with the WHODAS. Secondary outcomes are posttraumatic stress disorder (PTSD) symptoms, and client-perceived priority problems. Further, cost-effectiveness will be assessed using the Service Receipt Inventory (SRI). Discussion If proven effective, PM+ will be rolled out to other areas for further adaptation and testing in diverse humanitarian settings. Trial registration ACTRN12614001235695. Registered 26 November 2014. Australian New Zealand Clinical Trials Registry

Mental disorders are significant contributors to the global burden of disease (1). While they occur across all levels of socio-economic status, the majority of populations in low- and middle-income countries (LMICs) do not have access to effective psychological and pharmacological interventions (2). Key barriers to sustainable delivery of psychological therapies in LMICs include limited mental health funding and infrastructure, chronic shortage of mental health professionals, lack of treatments adapted to the local context, and challenges associated with training and supervision. Implementation of low-intensity psychological interventions by trained para-professionals is one potential solution to this problem (3,4) which is receiving significant attention as part of global mental health research agendas (e.g.,(5)). A number of low-intensity interventions have demonstrated clinical benefit and utility in high-income settings. For example, early analyses of the UK’s Improving Access to Psychological Therapies programme (IAPT,(6)) found a substantial reduction in depression and anxiety in people who attended at least two sessions of low-intensity interventions. Additionally, a recent meta-analysis challenged conventional thinking and provided support for low-intensity interventions as an effective treatment even for individuals with symptoms of severe depression (7). Evidence for the applicability of psychological interventions by non-specialists in LMICs is mounting (8,9). For instance, group interpersonal psychotherapy facilitated by local para-professionals has been shown to be effective in rural Uganda among depressed adults compared to usual care at six month follow-up (10). In rural Pakistan, Rahman et al (11) found that local community health workers could effectively deliver a locally adapted cognitive-behavioural intervention for perinatal depression. Mothers receiving the treatment demonstrated significant clinical improvement on depression symptoms, showed less disability and better overall and social functioning. Finally, a comparatively more intensive transdiagnostic intervention, the Common Elements Treatment Approach (CETA), has shown promising results for the treatment of symptoms of depression, anxiety and post-traumatic stress in Burmese refugees when delivered by para-professionals (12). To fill the gap between mental health needs and access to quality care, and extend the current research on low-intensity interventions in LMICs, the World Health Organization (WHO) – as part of its Mental Health Gap Action Programme (mhGAP) – has begun to develop and test low-intensity psychological interventions. The current paper focuses on one such intervention, named Problem Management Plus (PM+).

The mental health consequences of conflict and natural disaster are substantial and wide‐ranging1, 2. There is an urgent need for interventions by non‐specialist workers that can address a range of mental health problems3. The World Health Organization (WHO)'s Problem Management Plus (PM+) is a brief transdiagnostic psychological intervention employing evidence‐based strategies of problem solving, behavioural activation, strengthening social support, and stress management4. We adapted the individual treatment format of this intervention for conflict‐affected Peshawar in Pakistan. It consisted of five face‐to‐face sessions, with a key feature of being affordable in most settings, because it can be offered not only by specialists but also by supervised non‐specialists with no prior training or experience in mental health care delivery. We used an apprenticeship (on‐the‐job learning) model for training and supervising the non‐specialists5, which involved an initial 6‐day training programme by a master trainer to local mental health specialists, who in turn provided an 8‐day training programme to six non‐specialists. Training of both supervisors and non‐specialists was followed by four weeks of practice under supervision of the local trainers. The local trainers themselves were supervised 3‐weekly through audio calls by the master trainer, building skills in the intervention as well as in training and supervision. All non‐specialists were evaluated for their competency by independent assessors using a competency rating tool evaluating basic helping skills and use of PM+ strategies through observation of specially designed role plays. Competency was rated using a 5‐point scale. In total, four out of six achieved scores indicating competency in all basic helping skills and five out of six achieved all competency scores on PM+ strategies. Following additional training and supervision, all non‐specialists demonstrated adequate proficiency in requisite skills. We conducted a single‐blind pilot randomized controlled trial (RCT) to explore the feasibility and acceptability of the intervention in Peshawar. PM+ was compared to enhanced treatment as usual, consisting of management by primary care physician who received one day of basic training in treatment of common mental disorders. The study was conducted from March to May 2014 in two primary care centres in Gulbahar Union Council, a low‐income peri‐urban locality in Peshawar district. Participants were primary care attenders aged 18 or above, referred for screening by the primary care physician. Screening was conducted by trained members of the research team following informed consent to recruit persons with both marked distress and impairment. Invited participants scored: a) 2 or above on the General Health Questionnaire (GHQ‐12)6, a 12 item questionnaire of general psychological distress with a 4‐point scale ranging from 0 to 3 scored bi‐modally when used as a screener (possible range 0‐12), and b) 17 or above on the WHO Disability Assessment Schedule (WHODAS 2.0)7, a screener for functional impairment with 12 items measured on a scale ranging from 1 to 5 (possible range 12‐60). We excluded individuals with imminent suicide risk, severe cognitive impairment (e.g., severe intellectual disability or dementia) or with expressed acute needs/protection risks (e.g., recent abandonment by husband and his family). We also excluded individuals who reported having experienced a major traumatic event during the past month and individuals with severe mental disorder (psychotic disorders, substance dependence). Individuals meeting the exclusion criteria were referred to specialist centres depending upon their needs. Ethical approvals were obtained from the Ethics Review Board at the Lady Reading Hospital, Peshawar, and WHO's Ethical Review Committee. Approval was also obtained from the district primary care administration. Participants were interviewed after voluntary written consent. Out of 1,286 people seen by a physician during the study period, 94 were referred for screening, 85 met study criteria, 81 were accessible, and 60 consented to participate in the trial. Randomization to the PM+ intervention or enhanced treatment as usual was performed by an independent researcher not involved in the project using computerized software on a 1:1 basis, stratified for gender. Nine out of 60 (15%) – five from the intervention arm and four from the control arm – were lost to follow‐up. The groups were well‐balanced at baseline for demographic and clinical variables. The primary outcome, assessed by independent raters, was psychological distress, measured by GHQ‐12 with scores being the total sum across 12 items (possible range 0‐36). Other outcomes included: functioning, measured using the 12‐item interviewer‐administered screener version of the WHODAS 2.0; and post‐traumatic stress symptoms, measured using the PTSD Checklist for DSM‐5 (PCL‐5)8, which is a 20‐item checklist corresponding to the twenty DSM‐5 PTSD symptoms in the last week, with items rated on a 0‐4 scale (possible range 0‐80). The intervention had high uptake, with 22/30 (73%) completing all sessions. The intervention arm showed improvement in functioning (mean WHODAS 2.0 scores reduced from 17.7 ± 9.2 to 6.6 ± 6.1 vs. 17.0 ± 10.5 to 11.3 ± 10.4 in controls) and in post‐traumatic stress symptoms (mean PCL‐5 scores reduced from 34.2 ± 20.1 to 9.8 ± 9.1 vs. 32.3 ± 17.1 to 19.5 ± 18.5 in controls). Due to skewed distribution and variance heterogeneity of the outcome variable, log‐linear regression was carried out. After adjustment of baseline scores, the results showed a reduction of 90% in geometric mean within the intervention group (95% CI: 90.4%‐91.7%, p=0.04) in WHODAS 2.0 scores and a reduction of 92% (95% CI: 91.2%‐92.3%, p=0.02) in post‐traumatic stress symptoms. There was no significant change in GHQ‐12 scores. On qualitative evaluation of a sub‐sample of participants and primary care staff, we found that the intervention was perceived as useful, and was successfully integrated into primary care centres. As this was a pilot study with a small sample size, recruited through primary care physician referral, and no power calculations were carried out, the findings and their generalizability warrant a cautious interpretation. However, a successful conduction in challenging settings, with adequate enrolment rate, a low drop‐out, and balanced randomization provides evidence that RCTs are feasible in such settings. The intervention delivery through non‐specialists with no prior mental health care experience and the encouraging results demonstrate the feasibility of the task shifting approach, and are consistent with previous reports9, 10. The results of this pilot study should encourage further adaptation and large‐scale fully‐powered RCTs of this new, transdiagnostic psychological intervention4. Atif Rahman1,2, Naila Riaz3, Katie S. Dawson4, Syed Usman Hamdani2, Anna Chiumento1, Marit Sijbrandij5, Fareed Minhas6, Richard A. Bryant4, Khalid Saeed7, Mark van Ommeren8, Saeed Farooq3 1University of Liverpool, Liverpool, UK; 2Human Development Research Foundation, Islamabad, Pakistan; 3Lady Reading Hospital, Peshawar, Pakistan; 4University of New South Wales, Sydney, Australia; 5VU University Amsterdam, Amsterdam, The Netherlands; 6Institute of Psychiatry, Rawalpindi, Pakistan; 7Mental Health and Substance Abuse Unit, Regional Office for the Eastern Mediterranean Region, World Health Organization, Cairo, Egypt; 8Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland

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., HIGHLIGHTS Feasibility trial of GroupPM+ in a Syrian refugee camp in Jordan. 64 participants randomized; safety and cultural acceptance was observed. Positive results support the readiness for a definitive RCT to test effectiveness and cost-effectiveness.