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.

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 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 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.

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.

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.

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.

Brief videoconferencing psychological intervention for reducing COVID-19 related distress: study protocol for a randomized controlled trial.

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 ).

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

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

Efficacy of exposure-based cognitive behaviour therapy for post-traumatic stress disorder in emergency service personnel: a randomised clinical trial.

BACKGROUND: Although 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). METHOD: One 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. RESULTS: At 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. CONCLUSIONS: This study highlights that CBT, which can include either long or brief imaginal exposure, is efficacious in reducing PTSD in emergency service personnel.

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

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

A controlled trial of trauma-focused therapy versus problem-solving in Islamic children affected by civil conflict and disaster in Aceh, Indonesia.

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.

Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial.

BACKGROUND: Gender-based violence (GBV) represents a major cause of psychological morbidity worldwide, and particularly in low- and middle-income countries (LMICs). Although there are effective treatments for common mental disorders associated with GBV, they typically require lengthy treatment programs that may limit scaling up in LMICs. The aim of this study was to test the effectiveness of a new 5-session behavioural treatment called Problem Management Plus (PM+) that lay community workers can be taught to deliver. METHODS AND FINDINGS: In this single-blind, parallel, randomised controlled trial, adult women who had experienced GBV were identified through community screening for psychological distress and impaired functioning in Nairobi, Kenya. Participants were randomly allocated in a 1:1 ratio either to PM+ delivered in the community by lay community health workers provided with 8 days of training or to facility-based enhanced usual care (EUC) provided by community nurses. Participants were aware of treatment allocation, but research assessors were blinded. The primary outcome was psychological distress as measured by the total score on the 12-item General Health Questionnaire (GHQ-12) assessed at 3 months after treatment. Secondary outcomes were impaired functioning (measured by the WHO Disability Adjustment Schedule [WHODAS]), symptoms of posttraumatic stress (measured by the Posttraumatic Stress Disorder Checklist [PCL]), personally identified problems (measured by Psychological Outcome Profiles [PSYCHLOPS]), stressful life events (measured by the Life Events Checklist [LEC]), and health service utilisation. Between 15 April 2015 and 20 August 2015, 1,393 women were screened for eligibility on the basis of psychological distress and impaired functioning. Of these, 518 women (37%) screened positive, of whom 421 (81%) were women who had experienced GBV. Of these 421 women, 209 were assigned to PM+ and 212 to EUC. Follow-up assessments were completed on 16 January 2016. The primary analysis was intention to treat and included 53 women in PM+ (25%) and 49 women in EUC (23%) lost to follow-up. The difference between PM+ and EUC in the change from baseline to 3 months on the GHQ-12 was 3.33 (95% CI 1.86-4.79, P = 0.001) in favour of PM+. In terms of secondary outcomes, for WHODAS the difference between PM+ and EUC in the change from baseline to 3-month follow-up was 1.96 (95% CI 0.21-3.71, P = 0.03), for PCL it was 3.95 (95% CI 0.06-7.83, P = 0.05), and for PSYCHLOPS it was 2.15 (95% CI 0.98-3.32, P = 0.001), all in favour of PM+. These estimated differences correspond to moderate effect sizes in favour of PM+ for GHQ-12 score (0.57, 95% CI 0.32-0.83) and PSYCHLOPS (0.67, 95% CI 0.31-1.03), and small effect sizes for WHODAS (0.26, 95% CI 0.02-0.50) and PCL (0.21, 95% CI 0.00-0.41). Twelve adverse events were reported, all of which were suicidal risks detected during screening. No adverse events were attributable to the interventions or the trial. Limitations of the study include no long-term follow-up, reliance on self-report rather than structured interview data, and lack of an attention control condition. CONCLUSIONS: Among a community sample of women in urban Kenya with a history of GBV, a brief, lay-administered behavioural intervention, compared with EUC, resulted in moderate reductions in psychological distress at 3-month follow-up. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614001291673.

Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi.

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ACTRN12614001291673 , 10/12/2014, retrospectively registered during the recruitment phase.

Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial.

Importance: 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. Objective: To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. Design, Setting, and Participants: 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). Interventions: 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. Main Outcomes and Measures: 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). Results: 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). Conclusions and Relevance: 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. Trial Registration: anzctr.org.au Identifier: ANZCTR12614001235695.

Problem Management Plus (PM+) for common mental disorders in a humanitarian setting in Pakistan; study protocol for a randomised controlled trial (RCT).

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.

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.

A pilot study of the role of the BDNF Val66Met polymorphism in response to exercise-augmented exposure therapy for posttraumatic stress disorder.

Brain-Derived Neurotrophic Factor (BDNF) is implicated in extinction learning, which is a primary mechanism of exposure therapy for posttraumatic stress disorder (PTSD). Brief aerobic exercise has been shown to promote BDNF release and augment extinction learning. On the premise that the Val allele of the BDNF Val66Met polymorphism facilitates greater release of BDNF, this study examined the extent to which the Val allele of the BDNF polymorphism predicted treatment response in PTSD patients who underwent exposure therapy combined with aerobic exercise or passive stretching. PTSD patients (N = 85) provided saliva samples in order to extract genomic DNA to identify Val/Val and Met carriers of the BDNF Val66Met genotype, and were assessed for PTSD severity prior to and following a 9-week course of exposure therapy combined with aerobic exercise or stretching. The sample comprised 52 Val/Val carriers and 33 Met carriers. Patients with the BDNF high-expression Val allele display greater reduction of PTSD symptoms at posttreatment than Met carriers. Hierarchical regression analysis indicated that greater PTSD reduction was specifically observed in Val/Val carriers who received exposure therapy in combination with the aerobic exercise. This finding accords with animal and human evidence that the BDNF Val allele promotes greater extinction learning, and that these individuals may benefit more from exercise-augmented extinction. Although preliminary, this result represents a possible avenue for augmented exposure therapy in patients with the BDNF Val allele.

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.

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.