Dimensionality of the Swahili version of the General Health Questionnaire (GHQ-12) in a Kenyan population: A confirmatory factor analysis.

The current study evaluated the Kiswahili version of General Health Questionnaire (GHQ-12) in a Kenyan context comprising of women exposed to gender-based violence. Participants were randomly drawn from community sampling using household screening methods in peri-urban areas in Nairobi. A total of 1,394 participants with varying levels of literacy (years of education: mean [M] = 9.42; standard deviation [SD] = 3.73) and aged between 18 and 89 years were recruited for the study. The observed factor structure of the GHQ-12 was evaluated using six most tested models querying the dimensionality of the instrument insofar as the impacts of positive and negative wording effects in driving multidimensionality. Results from the confirmatory factor analysis supported a bifactor model, consisting of a general distress factor and two separate factors representing common variance due to the positive and negative wording of items. Overall, the findings support the use of the Kiswahili version of the GHQ-12 as a unidimensional construct with method-specific variance owing to wording effects. Importantly, GHQ-12 responses from a sample of Kenyan women with relatively low levels of literacy are congruent with the factor structure observed in other cross-cultural settings in low- and-middle-income countries.

Retrospective study of laboratory-based surveillance of rabies in wild and domestic animals in the southern United States, 2010-2021.

We performed a retrospective study of all case submissions for the rabies virus (RABV) direct fluorescent antibody test (DFAT) requested of the Tifton Veterinary Diagnostic and Investigational Laboratory (Tifton, GA, USA) between July 2010 and June 2021. Submitted were 792 samples from 23 animal species from 89 counties in Georgia, and 4 neighboring counties in Florida, 1 in South Carolina, and 1 in Alabama. In 13 (1.6%) cases, the DFAT result was inconclusive; 779 (98.4%) cases had a conclusive (positive or negative) test result. Of these 779 cases, 79 (10.1%) tested positive across 10 species. The remaining 700 (89.9%) cases were negative. The main reason for submission for RABV testing was human exposure to a potentially rabid animal in 414 (52.3%) cases. Among the 79 positive cases, 74 (93.7%) involved wildlife; raccoons (51 cases; 68.9%) were the primary host confirmed with RABV infection, followed by skunk and fox (8 cases each; 10.8%), bobcat (5 cases; 6.8%), and bats (2 cases; 2.7%). Only 5 domestic animals (6.3% of the positive cases) tested positive during our study period; one from each of the bovine, canine, caprine, equine, and feline species. Hence, the sylvatic cycle plays the predominant role in circulating RABV infection in our study area.

Cognitive Behavior Therapy vs Mindfulness in Treatment of Prolonged Grief Disorder: A Randomized Clinical Trial.

Importance: Although grief-focused cognitive behavior therapies are the most empirically supported treatment for prolonged grief disorder, many people find this treatment difficult. A viable alternative for treatment is mindfulness-based cognitive therapy. Objective: To examine the relative efficacies of grief-focused cognitive behavior therapy and mindfulness-based cognitive therapy to reduce prolonged grief disorder severity. Design, Setting, and Participants: A single-blind, parallel, randomized clinical trial was conducted among adults aged 18 to 70 years with prolonged grief disorder, as defined in the International Classification of Diseases, 11th Revision, and assessed by clinical interview based on the Prolonged Grief-13 (PG-13) scale. Those with severe suicidal risk, presence of psychosis, or substance dependence were excluded. Between November 2012 and November 2022, eligible participants were randomized 1:1 to eleven 90-minute sessions of grief-focused cognitive behavior therapy or mindfulness-based cognitive therapy at a traumatic stress clinic in Sydney, Australia, with follow-up through 6 months. Interventions: Both groups received once-weekly 90-minute individual sessions for 11 weeks. Grief-focused cognitive behavior therapy comprised 5 sessions of recalling memories of the deceased, plus cognitive restructuring and planning future social and positive activities. Mindfulness-based cognitive therapy comprised mindfulness exercises adapted to tolerate grief-related distress. Main Outcomes and Measures: The primary outcome was change in prolonged grief disorder severity measured by the PG-13 scale assessed at baseline, 1 week posttreatment, and 6 months after treatment (primary outcome time point), as well as secondary outcome measures of depression, anxiety, grief-related cognition, and quality of life. Results: The trial included 100 participants (mean [SD] age, 47.3 [13.4] years; 87 [87.0%] female), 50 in the grief-focused cognitive behavior therapy condition and 50 in the mindfulness-based cognitive therapy condition. Linear mixed models indicated that at the 6-month assessment, participants in the grief-focused cognitive behavior therapy group showed greater reduction in PG-13 scale score relative to those in the mindfulness-based cognitive therapy group (mean difference, 7.1; 95% CI, 1.6-12.5; P = .01), with a large between-group effect size (0.8; 95% CI, 0.2-1.3). Participants in the grief-focused cognitive behavior therapy group also demonstrated greater reductions in depression as measured on the Beck Depression Inventory than those in the mindfulness-based cognitive therapy group (mean difference, 6.6; 95% CI, 0.5-12.9; P = .04) and grief-related cognition (mean difference, 14.4; 95% CI, 2.8-25.9; P = .02). There were no other significant differences between treatment groups and no reported adverse events. Conclusions and Relevance: In this study, grief-focused cognitive behavior therapy conferred more benefit for core prolonged grief disorder symptoms and associated problems 6 months after treatment than mindfulness-based cognitive therapy. Although both treatments may be considered for prolonged grief disorder, grief-focused cognitive behavior therapy might be the more effective choice, taking all factors into consideration. Trial Registration: anzctr.org.au Identifier: ACTRN12612000307808.

Efficacy and moderators of efficacy of cognitive behavioural therapies with a trauma focus in children and adolescents: an individual participant data meta-analysis of randomised trials.

BACKGROUND: Existing clinical trials of cognitive behavioural therapies with a trauma focus (CBTs-TF) are underpowered to examine key variables that might moderate treatment effects. We aimed to determine the efficacy of CBTs-TF for young people, relative to passive and active control conditions, and elucidate putative individual-level and treatment-level moderators. METHODS: This was an individual participant data meta-analysis of published and unpublished randomised studies in young people aged 6-18 years exposed to trauma. We included studies identified by the latest UK National Institute of Health and Care Excellence guidelines (completed on Jan 29, 2018) and updated their search. The search strategy included database searches restricted to publications between Jan 1, 2018, and Nov 12, 2019; grey literature search of trial registries ClinicalTrials.gov and ISRCTN; preprint archives PsyArXiv and bioRxiv; and use of social media and emails to key authors to identify any unpublished datasets. The primary outcome was post-traumatic stress symptoms after treatment (<1 month after the final session). Predominantly, one-stage random-effects models were fitted. This study is registered with PROSPERO, CRD42019151954. FINDINGS: We identified 38 studies; 25 studies provided individual participant data, comprising 1686 young people (mean age 13·65 years [SD 3·01]), with 802 receiving CBTs-TF and 884 a control condition. The risk-of-bias assessment indicated five studies as low risk and 20 studies with some concerns. Participants who received CBTs-TF had lower mean post-traumatic stress symptoms after treatment than those who received the control conditions, after adjusting for post-traumatic stress symptoms before treatment (b=-13·17, 95% CI -17·84 to -8·50, p<0·001, τ2=103·72). Moderation analysis indicated that this effect of CBTs-TF on post-traumatic stress symptoms post-treatment increased by 0·15 units (b=-0·15, 95% CI -0·29 to -0·01, p=0·041, τ2=0·03) for each unit increase in pre-treatment post-traumatic stress symptoms. INTERPRETATION: This is the first individual participant data meta-analysis of young people exposed to trauma. Our findings support CBTs-TF as the first-line treatment, irrespective of age, gender, trauma characteristics, or carer involvement in treatment, with particular benefits for those with higher initial distress. FUNDING: Swiss National Science Foundation.

Positive affect training to reduce mental health problems during the COVID-19 pandemic: a proof-of-concept randomised clinical trial.

BACKGROUND: The social restrictions occurring during the pandemic contributed to loss of many sources of reward, which contributes to poor mental health. OBJECTIVE: This trial evaluated a brief positive affect training programme to reduce anxiety, depression and suicidality during the pandemic. METHODS: In this single-blind, parallel, randomised controlled trial, adults who screened positive for COVID-19-related psychological distress across Australia were randomly allocated to either a 6-session group-based programme based on positive affect training (n=87) or enhanced usual care (EUC, n=87). Primary outcome was total score on the Hospital Anxiety and Depression Scale-anxiety and depression subscales assessed at baseline, 1-week post-treatment, 3 months (primary outcome time point) as well as secondary outcome measures of suicidality, generalised anxiety disorder, sleep impairment, positive and negative mood and COVID-19-related stress. FINDINGS: Between 20 September 2020 and 16 September 2021, 174 participants were enrolled into the trial. Relative to EUC, at 3-month follow-up the intervention led to greater reduction on depression (mean difference 1.2 (95% CI 0.4 to 1.9)), p=0.003), with a moderate effect size (0.5 (95% CI 0.2 to 0.9)). There were also greater reduction of suicidality and improvement in quality of life. There were no differences in anxiety, generalised anxiety, anhedonia, sleep impairment, positive or negative mood or COVID-19 concerns. CONCLUSIONS: This intervention was able to reduce depression and suicidality during adverse experiences when rewarding events were diminished, such as pandemics. CLINICAL IMPLICATIONS: Strategies to improve positive affect may be useful to reduce mental health issues. TRIAL REGISTRATION NUMBER: ACTRN12620000811909.

Habituation of distress during exposure and its relationship to treatment outcome in post-traumatic stress disorder and prolonged grief disorder.

Background: Reliving distressing memories is a core component of treatments for post-traumatic stress disorder (PTSD) and prolonged grief disorder (PGD). There is little understanding of how reliving these memories functions in the treatment of these disorders.Objective: This study investigated whether reliving functions comparably in the treatment of PTSD and PGD, and whether it is comparably related to treatment outcome.Method: This study conducted a reanalysis of patients with either PTSD (n = 55) or PGD (n = 45) who underwent treatments that comprised at least four sessions of reliving memories of either their traumatic experience or the loss of the deceased person.Results: PTSD participants displayed greater habituation of distress across sessions during reliving than PGD participants. Between-session reduction in distress during reliving was associated with symptom remission in PTSD, but this pattern was not observed in PGD.Conclusion: This pattern of findings indicates that although reliving appears to be a useful strategy for treating both PTSD and PGD, this strategy does not function comparably in the two conditions and may involve distinct mechanisms.

Reliving distressing memories is key to treatment of PTSD and prolonged grief disorder.Distress during memory reliving habituated in PTSD treatment more than in treatment of grief.Habituation of distress during treatment predicted remission of symptoms in PTSD but not grief.

Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus.

BACKGROUND: The mental health burden among refugees in high-income countries (HICs) is high, whereas access to mental healthcare can be limited. OBJECTIVE: To examine the effectiveness of a peer-provided psychological intervention (Problem Management Plus; PM+) in reducing symptoms of common mental disorders (CMDs) among Syrian refugees in the Netherlands. METHODS: We conducted a single-blind, randomised controlled trial among adult Syrian refugees recruited in March 2019-December 2021 (No. NTR7552). Individuals with psychological distress (Kessler Psychological Distress Scale (K10) >15) and functional impairment (WHO Disability Assessment Schedule (WHODAS 2.0) >16) were allocated to PM+ in addition to care as usual (PM+/CAU) or CAU only. Participants were reassessed at 1-week and 3-month follow-up. Primary outcome was depression/anxiety combined (Hopkins Symptom Checklist; HSCL-25) at 3-month follow-up. Secondary outcomes included depression (HSCL-25), anxiety (HSCL-25), post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; PCL-5), impairment (WHODAS 2.0) and self-identified problems (PSYCHLOPS; Psychological Outcomes Profiles). Primary analysis was intention-to-treat. FINDINGS: Participants (n=206; mean age=37 years, 62% men) were randomised into PM+/CAU (n=103) or CAU (n=103). At 3-month follow-up, PM+/CAU had greater reductions on depression/anxiety relative to CAU (mean difference -0.25; 95% CI -0.385 to -0.122; p=0.0001, Cohen's d=0.41). PM+/CAU also showed greater reductions on depression (p=0.0002, Cohen's d=0.42), anxiety (p=0.001, Cohen's d=0.27), PTSD symptoms (p=0.0005, Cohen's d=0.39) and self-identified problems (p=0.03, Cohen's d=0.26), but not on impairment (p=0.084, Cohen's d=0.21). CONCLUSIONS: PM+ effectively reduces symptoms of CMDs among Syrian refugees. A strength was high retention at follow-up. Generalisability is limited by predominantly including refugees with a resident permit. CLINICAL IMPLICATIONS: Peer-provided psychological interventions should be considered for scale-up in HICs.

Study protocol for a controlled trial of a resilience program on psychological distress in correctional officers in Australia.

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.

Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial.

BACKGROUND: 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. METHODS: 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). FINDINGS: 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. INTERPRETATION: 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. FUNDING: Australian National Health and Medical Research Council.

Videoconferencing-delivered psychological intervention for the treatment of COVID-19 related psychological distress in University students: study protocol for a randomised controlled trial in India.

BACKGROUND: The mental health impacts of the COVID-19 pandemic have been profound. This paper outlines the study protocol for a trial that tests the efficacy of a brief group-based psychological intervention (Coping with COVID; CWC), relative to Supportive Counselling, to reduce distress associated with COVID-19 in a young adult population in Bangalore, India. METHODS: A single-blind, parallel, randomized controlled trial will be carried out via video conferencing in a small group format. Following informed consent, adults that screen positive for levels of psychological distress (Kessler 10 (K-10 score ≥ 20) and have access to a videoconferencing platform will be randomised to an adapted version of CWC (n = 90) or Supportive Counselling (SC) (n = 90). The primary outcome will be reduction in psychological distress including anxiety and depression at 2-months post treatment. Secondary outcomes include worry, positive wellbeing, and stress in relation to COVID-19. DISCUSSION: This treatment trial will assess whether CWC will result in reduced distress relative to Supportive Counselling in a young adult population in Bangalore, India. This study will yield important insights into the role of nonspecific factors versus the intervention's components in impacting COVID-19 related distress. TRIAL REGISTRATION: This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12621001064897). ETHICS AND DISSEMINATION: Ethics approval has been obtained from the participating institution, CHRIST University in Bangalore. 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.

Twelve-month follow-up of a randomised clinical trial of a brief group psychological intervention for common mental disorders in Syrian refugees in Jordan.

AIMS: There 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. METHODS: This 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. RESULTS: Between 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. CONCLUSIONS: The 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 + .

Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial.

BACKGROUND: Millions of young adolescents in low- and middle-income countries (LMICs) affected by humanitarian crises experience elevated rates of poor mental health. There is a need for scalable programs that can improve the mental health of young adolescents. This study evaluated the effectiveness of a nonspecialist delivered group-based intervention (Early Adolescent Skills for Emotions (EASE)) to improve young adolescents' mental health. METHODS AND FINDINGS: In this single-blind, parallel, controlled trial, Syrian refugees aged 10 to 14 years in Jordan were identified through screening of psychological distress as defined by scores ≥15 on the Paediatric Symptom Scale. Participants were randomised to either EASE or enhanced usual care (EUC) involving referral to local psychosocial services (on a 1:1.6 ratio). Participants were aware of treatment allocation but assessors were blinded. Primary outcomes were scores on the Paediatric Symptom Checklist (PSC; internalising, externalising, and attentional difficulty scales) assessed at week 0, 9 weeks, and 3 months after treatment (primary outcome time point). It was hypothesised that EASE would result in greater reductions on internalising symptoms than EUC. Secondary outcomes were depression, posttraumatic stress, well-being, functioning, school belongingness, and caregivers' parenting and mental health. Between June 2019 and January 2020, 1,842 young adolescent refugees were screened for eligibility on the basis of psychological distress. There were 520 adolescents (28.2%) who screened positive, of whom 471 (90.6%) agreed to enter the trial. Overall, 185 were assigned to EASE and 286 to EUC, and 169 and 254 were retained at 3 months for EASE and EUC, respectively. Intent-to-treat analyses indicated that at 3 months, EASE resulted in greater reduction on the PSC-internalising scale than EUC (estimated mean difference 0.69, 95% CI 0.19 to 1.19; p = 0.007; effect size, 0.38) but there were no differences for PSC-externalising (estimated mean difference 0.24, 95% CI -0.43 to 0.91; p = 0.49; effect size, -0.10), PSC-attentional problem (estimated mean difference -0.01, 95% CI -0.51 to 0.54; p = 0.97; effect size, -0.01) scores, or on depression, posttraumatic stress, well-being, functioning, or school belongingness. Relative to EUC, caregivers in EASE had less psychological distress (estimated mean difference 1.95, 95% CI 0.71 to 3.19; p = 0.002) and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < 0.001). Secondary analyses that (a) focused on adolescents with probable internalising disorders; (b) completed the 3-month assessment; and (c) controlled for trauma exposure did not alter the primary results. Mediation analysis indicated that for caregivers in the EASE condition, reduction in inconsistent disciplinary parenting was associated with reduced attentional (ß = 0.11, SE 0.07; 95% CI 0.003, 0.274) and internalising (ß = 0.11, SE 0.07; 95% CI 0.003, 0.274) problems in their children. No adverse events were attributable to the intervention. A limitation was that EUC was not matched to EASE in terms of facilitator attention or group involvement. CONCLUSIONS: EASE led to reduced internalising problems in young refugee adolescents and was associated with reduced distress and less inconsistent disciplinary parenting in caregivers. This intervention has the potential as a scalable intervention to mitigate young adolescents' emotional difficulties in LMIC. TRIAL REGISTRATION: Prospectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619000341123.

Effectiveness of a brief group behavioral intervention for common mental disorders in Syrian refugees in Jordan: A randomized controlled trial.

BACKGROUND: Common mental disorders are frequently experienced by refugees. This study evaluates the impact of a brief, lay provider delivered group-based psychological intervention [Group Problem Management Plus (gPM+)] on the mental health of refugees in a camp, as well as on parenting behavior and children's mental health. METHODS AND FINDINGS: In this single-blind, parallel, randomized controlled trial, 410 adult Syrian refugees (300 females, 110 males) in Azraq Refugee Camp (Jordan) were identified through screening of psychological distress (≥16 on the Kessler Psychological Distress Scale) and impaired functioning (≥17 on the WHO Disability Assessment Schedule). Participants were randomly allocated to gPM+ or enhanced usual care (EUC) involving referral information for psychosocial services on a 1:1 ratio. Participants were aware of treatment allocation, but assessors were blinded to treatment condition. Primary outcomes were scores on the Hopkins Symptom Checklist-25 (HSCL; depression and anxiety scales) assessed at baseline, 6 weeks, and 3 months follow-up as the primary outcome time point. It was hypothesized that gPM+ would result in greater reductions of scores on the HSCL than EUC. Secondary outcomes were disability, posttraumatic stress, personally identified problems, prolonged grief, prodromal psychotic symptoms, parenting behavior, and children's mental health. Between October 15, 2019 and March 2, 2020, 624 refugees were screened for eligibility, 462 (74.0%) screened positive, of whom 204 were assigned to gPM+ and 206 to EUC. There were 168 (82.4%) participants in gPM+ and 189 (91.7%) in EUC assessed at follow-up. Intent-to-treat analyses indicated that at follow-up, participants in gPM+ showed greater reduction on HSCL depression scale than those receiving EUC (mean difference, 3.69 [95% CI 1.90 to 5.48], p = .001; effect size, 0.40). There was no difference between conditions in anxiety (mean difference -0.56, 95% CI -2.09 to 0.96; p = .47; effect size, -0.03). Relative to EUC, participants in gPM+ had greater reductions in severity of personally identified problems (mean difference 0.88, 95% CI 0.07 to 1.69; p = .03), and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < .001). There were no significant differences between conditions for changes in PTSD, disability, grief, prodromal symptoms, or childhood mental health outcomes. Mediation analysis indicated the change in inconsistent disciplinary parenting was associated with reduced attentional (ß = 0.11, SE .07; 95% CI .003 to .274) and internalizing (ß = 0.08, SE .05; 95% CI .003 to 0.19) problems in children. No adverse events were attributable to the interventions or the trial. Major limitations included only one-quarter of participants being male, and measures of personally identified problems, grief, prodromal psychotic symptoms, inconsistent parenting behavior, and children's mental health have not been validated with Syrians. CONCLUSIONS: In camp-based Syrian refugees, a brief group behavioral intervention led to reduced depressive symptoms, personally identified problems, and disciplinary parenting compared to usual care, and this may have indirect benefits for refugees' children. The limited capacity of the intervention to reduce PTSD, disability, or children's psychological problems points to the need for development of more effective treatments for refugees in camp settings. TRIAL REGISTRATION: Prospectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619001386123.

Effectiveness of a Videoconferencing-Delivered Psychological Intervention for Mental Health Problems during COVID-19: A Proof-of-Concept Randomized Clinical Trial.

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.

Feasibility trial of a brief scalable psychological intervention for Syrian refugee adolescents in Jordan.

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.

Antecedentes: La mayoría de los refugiados tienen menos de 18 años y corren un mayor riesgo de padecer trastornos mentales comunes (TMC) en comparación con otros jóvenes. Existe limitada evidencia de programs psicosociales para jóvenes en entornos de bajos recursos. El program denominado Early Adolescent Skills for Emotions (EASE, por sus siglas en inglés) fue desarrollado por la Organización Mundial de la Salud con el objetivo de abordar esta brecha.Objetivos: Este estudio probó la seguridad, viabilidad y los procedimientos de la intervención EASE entre los jóvenes refugiados sirios en preparación para un ensayo controlado aleatorizado (RCT) definitivo.Métodos: Se realizó un RCT de viabilidad en Amman, Jordania, con niños sirios de 10 a 14 años que reportaron angustia psicológica. Después de la evaluación comunitaria, los jóvenes y sus cuidadores fueron asignados al azar para recibir la intervención EASE o el tratamiento como de costumbre mejorado (ETAU por sus siglas en ingles). EASE comprendió siete sesiones grupales para enseñar a los niños habilidades de afrontamiento, y los cuidadores recibieron tres sesiones grupales para potenciar las sesiones para jóvenes. Las evaluaciones se realizaron al inicio y una semana después de la última sesión de EASE (8 semanas después del inicio). Después del ensayo, se llevó a cabo una evaluación cualitativa del proceso con el personal y los beneficiarios. Los resultados principales fueron los indicadores de seguridad y viabilidad, y la angustia se midió mediante la lista de verificación de síntomas pediátricos.Resultados: En noviembre de 2018, se examinaron 179 niños; 61 (33%) cumplieron los criterios de angustia (34,1%), dos fueron excluidos por riesgo de suicidio y 59 fueron aleatorizados (EASE = 33, ETAU = 26). De los que recibieron EASE, 26 niños (79%) completaron la intervención. La asistencia al grupo fue alta y no se informaron eventos adversos en ninguno de los brazos. La angustia psicológica no mostró signos de disminuir a lo largo del tiempo en ninguno de los grupos.Conclusión: Este ensayo de viabilidad demostró seguridad y aceptabilidad de la intervención. Se aprendieron importantes lecciones con respecto a los criterios de ingreso al estudio y la participación de los cuidadores en la intervención. Se llevará a cabo un ensayo controlado aleatorizado totalmente potenciado para evaluar la eficacia de EASE.

Two-year follow-up of trauma-focused cognitive behavior therapy for posttraumatic stress disorder in emergency service personnel: A randomized clinical trial.

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.

Feasibility and acceptability of Problem Management Plus with Emotional Processing (PM+EP) for refugee youth living in the Netherlands: study protocol.

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.

Antecedentes: Los jóvenes refugiados experimentan dificultades relacionadas con la exposición al trauma en sus países de origen, tanto durante como después del desplazamiento. Esto resulta en tasas más elevadas de trastornos mentales comunes. La Organización Mundial de la Salud (OMS) desarrolló el programa Enfrentando Problemas Plus (EP+), una intervención psicológica breve brindada por personal no especializado para individuos que han sido expuestos a la adversidad. EP+ abarca la resolución de problemas, el manejo del estrés, la activación conductual y el fortalecimiento del soporte social. Sin embargo, no incluye un componente de procesamiento emocional, el cual es indicado en poblaciones expuestas al trauma.Objetivo: Este piloto de un ensayo clínico controlado y aleatorizado (ECA) tiene como objetivo evaluar la viabilidad y la aceptabilidad de EP+ adaptado para jóvenes refugiados sirios, eritreos e iraquíes que residen en los Países Bajos, con y sin un módulo de Procesamiento Emocional (PE) recientemente desarrollado.Métodos: Se aleatorizará a un grupo de refugiados jóvenes (N= 90) de entre 16 a 25 años a un grupo EP+ con atención habitual (AH), (n= 30), a un grupo EP+ con Procesamiento Emocional (EP+PE) con AH (n= 30), o un grupo de solamente AH (n= 30). Los criterios de inclusión son el completar los cuestionarios de autoreporte de malestar psicológico (Escala de Malestar Psicológico de Kessler; K10 >15) y de deterioro del funcionamiento diario (Cuestionario de Evaluación de la Discapacidad de la OMS; WHODAS 2.0 >16). Los participantes serán evaluados al inicio del estudio, una semana después de la intervención y a los 3 meses del seguimiento. El resultado principal es la viabilidad y aceptabilidad del programa EP+ adaptado y del EP+PE. Los resultados secundarios son el autoreporte de malestar psicológico, la discapacidad funcional, los síntomas de severidad y diagnóstico del trastorno de estrés postraumático (TEPT), el soporte social y los problemas autoidentificados. Luego de concluido el piloto del ECA, se procederá a una evaluación del proceso que incluirá a los participantes del ensayo, a las personas significativas de los participantes, a los colaboradores y a los profesionales de la salud mental (n=20) para evaluar sus experiencias con los programas EP+ y EP+PE.Resultados y conclusiones: Este es el primer estudio que evalúa la viabilidad de EP+ para este grupo de edad y con un módulo integrado de procesamiento emocional. Los resultados pueden brindar información al elaborar ECAs más grandes y a la implementación de intervenciones de EP+ entre jóvenes refugiados.

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

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

Antecedentes: Aproximadamente el 10% de refugiados sirios reside actualmente en campos de refugiados, lo que puede imponer estresores adicionales después de la migración. Con tasas elevadas de angustia psicológica y pocos recursos disponibles, los programas psicosociales de rotación de tareas son necesarios para brindar un cuidado adecuado. Uno de estos programas, desarrollado por la Organización Mundial de la Salud (OMS), es el Programa Grupal para el Manejo de Problemas Plus ('Group Problem Management Plus', o GroupPM+).Objetivos: Este estudio tuvo como objetivo el probar la seguridad y la aceptabilidad del GroupPM+ en un campo de refugiados e identificar las áreas de adaptación en preparación para un ensayo clínico controlado y aleatorizado (ECA).Métodos: Se llevó a cabo un ensayo clínico controlado y aleatorizado (ECA) de viabilidad en el campo de refugiados de Azraq en Jordania. Los criterios de inclusión fueron (1) ser un adulto sirios con una edad ≥ 18 años, (2) ser padre de un niño de 10 a 16 años, (3) experimentar angustia psicológica, definida mediante un puntaje ≥ 16 en la Escala de Malestar Psicológico de Kessler, y (4) un puntaje ≥ 17 en el Cuestionario para la Evaluación de la Discapacidad 2.0 de la OMS. Después de las evaluaciones iniciales, los participantes fueron distribuidos aleatoriamente para recibir la intervención mediante el GroupPM+ o para recibir el tratamiento usual optimizado. Las evaluaciones posteriores fueron conducidas una semana después de la última sesión del GroupPM+. Los resultados principales fueron la viabilidad y la aceptación del GroupPM+; los síntomas de ansiedad, de depresión, del trastorno de estrés postraumático (TEPT), la psicosis prodrómica, el duelo, y también se evaluó el auto-reporte de la angustia psicológica por parte del niño.Resultados: De las 207 personas evaluadas, 64 (31%) dieron positivo en presentar angustia psicológica. De las 35 personas incluidas de manera aleatoria en el grupo de intervención mediante el GroupPM+, 24 (69%) completaron la intervención. No se reportaron eventos adversos durante el ensayo clínico. Los niños cuyos padres recibieron la intervención mediante el GroupPM+ tuvieron una mayor reducción en los síntomas internalizantes y externalizantes después del tratamiento. 55 (86%) participantes completaron el seguimiento posterior a la evaluación. Estos resultados demuestran tanto la viabilidad de conducir el ensayo clínico en un campo de refugiados, como la aceptación de la intervención mediante el GroupPM+ por parte de los refugiados sirios.Conclusiones: De acuerdo con el ensayo de viabilidad, tanto los procedimientos de implementación como la intervención fueron seguros y culturalmente aceptables. Los resultados apoyan la preparación para un ECA definitivo para determinar la efectividad y costo-efectividad de la intervención en los campos de refugiados.

Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial.

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.

Development of the mental health cultural adaptation and contextualization for implementation (mhCACI) procedure: a systematic framework to prepare evidence-based psychological interventions for scaling.

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.