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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. 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. 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. ClinicalTrials.gov NCT03747055.

Social-evaluative stressors—experiences in which people feel they could be judged negatively—pose a major threat to adolescent mental health 1 – 3 and can cause young people to disengage from stressful pursuits, resulting in missed opportunities to acquire valuable skills. Here we show that replicable benefits for the stress responses of adolescents can be achieved with a short (around 30-min), scalable 'synergistic mindsets' intervention. This intervention, which is a self-administered online training module, synergistically targets both growth mindsets 4 (the idea that intelligence can be developed) and stress-can-be-enhancing mindsets 5 (the idea that one’s physiological stress response can fuel optimal performance). In six double-blind, randomized, controlled experiments that were conducted with secondary and post-secondary students in the United States, the synergistic mindsets intervention improved stress-related cognitions (study 1, n  = 2,717; study 2, n  = 755), cardiovascular reactivity (study 3, n  = 160; study 4, n  = 200), daily cortisol levels (study 5, n  = 118 students, n  = 1,213 observations), psychological well-being (studies 4 and 5), academic success (study 5) and anxiety symptoms during the 2020 COVID-19 lockdowns (study 6, n  = 341). Heterogeneity analyses (studies 3, 5 and 6) and a four-cell experiment (study 4) showed that the benefits of the intervention depended on addressing both mindsets—growth and stress—synergistically. Confidence in these conclusions comes from a conservative, Bayesian machine-learning statistical method for detecting heterogeneous effects 6 . Thus, our research has identified a treatment for adolescent stress that could, in principle, be scaled nationally at low cost. An online training module that synergistically targets two different mindsets can reduce stress levels in adolescents in the context of social-evaluative stressors—stressful experiences in which individuals fear that others are judging them negatively.

Exposure to violence has negative consequences on mental health. Armed-conflict in Colombia has widely affected Afro-descendants in the Pacific region. Evidence regarding effectiveness of mental health interventions is lacking in low-income settings, especially in areas with active conflict. The objective of this study is to evaluate an individualized Common Elements Treatment Approach (CETA), a transdiagnostic psychotherapy model based on Cognitive-Behavioral Therapy, for adult trauma survivors. A referred sample of 521 adult Afro-descendants from Buenaventura and Quibdó, Colombia, experiencing significant sadness, suffering or fear (score>0.77 in Total Mental Health Symptoms), with history of traumatic experiences, and with associated functional impairment were randomly allocated to CETA intervention, standby group without intervention, but under monthly monitoring, or a Narrative Community-Based Group Therapy. CETA was provided by trained Lay Psychosocial Community Workers without previous mental health experience, supervised by psychologists, during 12-14 weekly, 1.5-hour sessions. Symptoms were assessed with a locally validated survey built based on the Hopkins Symptom Checklist, the Harvard Trauma Questionnaire, the PTSD CheckList-Civilian Version, a qualitative study for additional general symptoms and a gender-specific functional impairment scale. CETA was compared with the control group and the intervention effects were calculated with mixed models using intention to treat analysis. Participant completion of follow-up was 75.1% and 13.2% voluntarily withdrew. Reduction in post-traumatic stress symptoms was significant in both municipalities when comparing intervention and control groups (mean difference), with a with a moderate effect size in Buenaventura (Cohen's d  =  0.70) and a small effect size in Quibdó (d = 0.31). In Buenaventura, the intervention also had significant effects on depression (large effect size d = 1.03), anxiety (large effect size d = 0.80) and functional impairment (moderate effect size d = 0.70). In Quibdó, it had no significant effect on these outcomes. Changes in Total Mental Health Symptoms were not significant in neither city. This trial suggests that CETA, can be effective in improving depression, anxiety, post-traumatic stress and function among victims of systematized violence in low-income and active conflict settings. Nonetheless, the difference of effectiveness between the two cities of intervention may indicate that we cannot assume that a mental health intervention known to be effective in one setting will be effective in another, even in similar circumstances and population. This may have special importance when implementing and reproducing these types of intervention in non-controlled circumstances. Further research should address these concerns. Results can be of use by governmental decision-makers when defining mental health programs for survivors. ClinicalTrials.gov NCT01856673 (https://clinicaltrials.gov/ct2/show/NCT01856673).

Interest in animal-assisted therapy has been fuelled by studies supporting the many health benefits. The purpose of this study was to better understand the impact of an animal-assisted therapy program on children response to stress and pain in the immediate post-surgical period. Forty children (3-17 years) were enrolled in the randomised open-label, controlled, pilot study. Patients were randomly assigned to the animal-assisted therapy-group (n = 20, who underwent a 20 min session with an animal-assisted therapy dog, after surgery) or the standard-group (n = 20, standard postoperative care). The study variables were determined in each patient, independently of the assigned group, by a researcher unblinded to the patient's group. The outcomes of the study were to define the neurological, cardiovascular and endocrinological impact of animal-assisted therapy in response to stress and pain. Electroencephalogram activity, heart rate, blood pressure, oxygen saturation, cerebral prefrontal oxygenation, salivary cortisol levels and the faces pain scale were considered as outcome measures. After entrance of the dog faster electroencephalogram diffuse beta-activity (> 14 Hz) was reported in all children of the animal-assisted therapy group; in the standard-group no beta-activity was recorded (100% vs 0%, p<0.001). During observation, some differences in the time profile between groups were observed for heart rate (test for interaction p = 0.018), oxygen saturation (test for interaction p = 0.06) and cerebral oxygenation (test for interaction p = 0.09). Systolic and diastolic blood pressure were influenced by animal-assisted therapy, though a higher variability in diastolic pressure was observed. Salivary cortisol levels did not show different behaviours over time between groups (p=0.70). Lower pain perception was noted in the animal-assisted group in comparison with the standard-group (p = 0.01). Animal-assisted therapy facilitated rapid recovery in vigilance and activity after anaesthesia, modified pain perception and induced emotional prefrontal responses. An adaptative cardiovascular response was also present. ClinicalTrials.gov NCT02284100.

The emerging concept of psychobiotics—live microorganisms with a potential mental health benefit—represents a novel approach for the management of stress-related conditions. The majority of studies have focused on animal models. Recent preclinical studies have identified the B. longum 1714 strain as a putative psychobiotic with an impact on stress-related behaviors, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown. We tested whether psychobiotic consumption could affect the stress response, cognition and brain activity patterns. In a within-participants design, healthy volunteers ( N= 22) completed cognitive assessments, resting electroencephalography and were exposed to a socially evaluated cold pressor test at baseline, post-placebo and post-psychobiotic. Increases in cortisol output and subjective anxiety in response to the socially evaluated cold pressor test were attenuated. Furthermore, daily reported stress was reduced by psychobiotic consumption. We also observed subtle improvements in hippocampus-dependent visuospatial memory performance, as well as enhanced frontal midline electroencephalographic mobility following psychobiotic consumption. These subtle but clear benefits are in line with the predicted impact from preclinical screening platforms. Our results indicate that consumption of B. longum 1714 is associated with reduced stress and improved memory. Further studies are warranted to evaluate the benefits of this putative psychobiotic in relevant stress-related conditions and to unravel the mechanisms underlying such effects.