Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial.

BACKGROUND: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. OBJECTIVE: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. METHODS: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. RESULTS: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005). CONCLUSIONS: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-016-1511-1.

'Does it matter how old I feel?' The role of subjective age in a psychosocial intervention for improving depressive symptomatology among older adults in Brazil (PROACTIVE).

OBJECTIVES: Depression is a prevalent mental health condition that also often affects older adults. The PROACTIVE psychosocial intervention was developed to reduce depressive symptomatology among older adults within primary care settings in Brazil. An important psychological marker that affects individuals' aging experience relates to how old people feel. Known as subjective age, this marker has been shown to be a risk factor for experiencing greater depressive symptoms if individuals report feeling older than their (chronological) age. In this study, we perform secondary analyses of the PROACTIVE cluster-randomized controlled trial to examine the role of subjective age. METHOD: The sample included 715 Brazilian older adults (74% female, Mage 68.6, SD = 6.9, age range: 60-94 years) randomized to intervention (n = 360, 74% female, Mage 68.4, SD = 6.6, age range: 60-89 years) or control (n = 355, 74% female, Mage 68.9, SD = 7.2, age range: 60-94 years) arms. Here our primary outcome was depressive symptoms at the 8-month follow-up assessed with the 9-item Patient Health Questionnaire (PHQ-9) as a continuous variable. Our previous analyses demonstrated improved recovery from depression at follow-up in the intervention compared with the control arm. RESULTS: Relevant main effects and interactions in regression models for PHQ-9 presented here found that those reporting older subjective age had worse depressive symptoms at follow-up but that they benefitted more from the intervention when initial levels of depression were high. For participants who reported younger subjective ages the intervention showed positive effects that were independent of initial levels of depression. CONCLUSION: Our findings emphasize the importance of investigating possible underlying mechanisms that can help clarify the impact of mental health interventions.

Understanding the effects of a complex psychological intervention on symptoms of depression in Goa, India: findings from a causal mediation analysis.

BACKGROUND: Understanding how and under what circumstances a highly effective psychological intervention, improved symptoms of depression is important to maximise its clinical effectiveness. AIMS: To address this complexity, we estimate the indirect effects of potentially important mediators to improve symptoms of depression (measured with the Patient Health Questionnaire (PHQ-9)) in the Healthy Activity Program trial. METHOD: Interventional in(direct) effects were used to decompose the total effect of the intervention on PHQ-9 scores into the direct and indirect effects. The following indirect effects were considered: characteristics of sessions, represented by the number of sessions and homework completed; behavioural activation, according to an adapted version of the Behavioural Activation for Depression Scale - Short Form; and extra sessions offered to participants who did not respond to the intervention. RESULTS: Of the total effect of the intervention measured through the difference in PHQ-9 scores between treatment arms (mean difference: -2.1, bias-corrected 95% CI -3.2 to -1.5), 34% was mediated through improved levels of behavioural activation (mean difference: -0.7, bias-corrected 95% CI -1.2 to -0.4). There was no evidence to support the mediating role of characteristics of the sessions nor the extra sessions offered to participants who did not respond to the treatment. CONCLUSIONS: Findings from our robust mediation analyses confirmed the importance of targeting behavioural activation. Contrary to published literature, our findings suggest that neither the number of sessions nor proportion of homework completed improved outcomes. Moreover, in this context, alternative treatments other than extra sessions should be considered for patients who do not respond to the intervention.

Relationship between the Bolsa Família national cash transfer programme and suicide incidence in Brazil: A quasi-experimental study.

BACKGROUND: Socioeconomic factors have been consistently associated with suicide, and economic recessions are linked to rising suicide rates. However, evidence on the impact of socioeconomic interventions to reduce suicide rates is limited. This study investigates the association of the world's largest conditional cash transfer programme with suicide rates in a cohort of half of the Brazilian population. METHODS AND FINDINGS: We used data from the 100 Million Brazilian Cohort, covering a 12-year period (2004 to 2015). It comprises socioeconomic and demographic information on 114,008,317 individuals, linked to the "Bolsa Família" programme (BFP) payroll database, and nationwide death registration data. BFP was implemented by the Brazilian government in 2004. We estimated the association of BFP using inverse probability of treatment weighting, estimating the weights for BFP beneficiaries (weight = 1) and nonbeneficiaries by the inverse probability of receiving treatment (weight = E(ps)/(1-E(ps))). We used an average treatment effect on the treated (ATT) estimator and fitted Poisson models to estimate the incidence rate ratios (IRRs) for suicide associated with BFP experience. At the cohort baseline, BFP beneficiaries were younger (median age 27.4 versus 35.4), had higher unemployment rates (56% versus 32%), a lower level of education, resided in rural areas, and experienced worse household conditions. There were 36,742 suicide cases among the 76,532,158 individuals aged 10 years, or older, followed for 489,500,000 person-years at risk. Suicide rates among beneficiaries and nonbeneficiaries were 5.4 (95% CI = 5.32, 5.47, p < 0.001) and 10.7 (95% CI = 10.51, 10.87, p < 0.001) per 100,000 individuals, respectively. BFP beneficiaries had a lower suicide rate than nonbeneficiaries (IRR = 0.44, 95% CI = 0.42, 0.45, p < 0.001). This association was stronger among women (IRR = 0.36, 95% CI = 0.33, 0.38, p < 0.001), and individuals aged between 25 and 59 (IRR = 0.41, 95% CI = 0.40, 0.43, p < 0.001). Study limitations include a lack of control for previous mental disorders and access to means of suicide, and the possible under-registration of suicide cases due to stigma. CONCLUSIONS: We observed that BFP was associated with lower suicide rates, with similar results in all sensitivity analyses. These findings should help to inform policymakers and health authorities to better design suicide prevention strategies. Targeting social determinants using cash transfer programmes could be important in limiting suicide, which is predicted to rise with the economic recession, consequent to the Coronavirus Disease 2019 (COVID-19) pandemic.

A peer-facilitated psychological group intervention for perinatal women living with HIV and depression in Tanzania-Healthy Options: A cluster-randomized controlled trial.

BACKGROUND: Perinatal women living with HIV (PWLH) have a greater risk of depression compared to other women; however, there are limited specialized mental health services available to them. We aimed to determine whether a stepped-care intervention facilitated by trained lay providers can improve mental health outcomes postpartum for PWLH. METHODS AND FINDINGS: Healthy Options is a cluster-randomized controlled study conducted in 16 government-managed antenatal care clinics that provided HIV care for pregnant women in urban Tanzania. Recruitment occurred from May 2015 through April 2016, with the final round of data collection completed in October 2017. Participants included a consecutive sample of pregnant women under 30 weeks of gestation, living with HIV and depression, and attending the study clinics. Control sites received enhanced usual care for depression (EUDC). Intervention sites received EUDC plus the Healthy Options intervention, which includes prenatal group sessions of problem-solving therapy (PST) plus cognitive behavioral therapy (CBT) sessions for individuals showing depressive symptoms at 6 weeks postdelivery. We assessed depressive symptoms comparable to major depressive disorder (MDD) using the Patient Health Questionnaire-9 (PHQ-9) with a locally validated cutoff at 9 months and 6 weeks postpartum. The primary time point is 9 months postpartum. We examined differences in outcomes using an intent-to-treat analysis with a complete case approach, meaning those with data at the relevant time point were included in the analysis. We used generalized estimating equations accounting for clustering. Of 818 women screened using the PHQ-9, 742 were determined eligible and enrolled (395 intervention; 347 control); 649 women (87.5%) participated in the first follow-up and 641 women (86.4%) in the second. A majority (270, 74.6%) of women in the intervention arm attended 5 or more PST sessions. Women enrolled in Healthy Options demonstrated a 67% (RR 0.33; 95% CI: 0.22, 0.51; p-value: <0.001; corresponding to a 25.7% difference in absolute risk) lower likelihood of depressive symptoms than women in control clusters at 6 weeks postpartum. At 9 months postpartum, women enrolled in Healthy Options demonstrated a nonsignificant 26% (RR 0.74; 95% CI: 0.42, 1.3; p-value: 0.281; corresponding to a 3.2% difference in absolute risk) lower likelihood of depressive symptoms than women in control clusters. Study limitations include not using diagnostic interviews to measure depression and not blinding data collectors to intervention status during follow-up. CONCLUSIONS: The Healthy Options intervention did not demonstrate reduction in depressive symptoms at 9 months postpartum, the primary outcome. Significant reductions were seen in depression symptoms at 6 weeks postpartum, the secondary outcome. Stepped-care interventions may be relevant for improving outcomes in the critical early postpartum window. TRIAL REGISTRATION: Clinical Trial registration number (closed to new participants) NCT02039973.

How much change is enough? Evidence from a longitudinal study on depression in UK primary care.

BACKGROUND: The Patient Health Questionnaire (PHQ-9), the Beck Depression Inventory (BDI-II) and the Generalised Anxiety Disorder Assessment (GAD-7) are widely used in the evaluation of interventions for depression and anxiety. The smallest reduction in depressive symptoms that matter to patients is known as the Minimum Clinically Important Difference (MCID). Little empirical study of the MCID for these scales exists. METHODS: A prospective cohort of 400 patients in UK primary care were interviewed on four occasions, 2 weeks apart. At each time point, participants completed all three questionnaires and a 'global rating of change' scale (GRS). MCID estimation relied on estimated changes in symptoms according to reported improvement on the GRS scale, stratified by baseline severity on the Clinical Interview Schedule (CIS-R). RESULTS: For moderate baseline severity, those who reported improvement on the GRS had a reduction of 21% (95% confidence interval (CI) -26.7 to -14.9) on the PHQ-9; 23% (95% CI -27.8 to -18.0) on the BDI-II and 26.8% (95% CI -33.5 to -20.1) on the GAD-7. The corresponding threshold scores below which participants were more likely to report improvement were -1.7, -3.5 and -1.5 points on the PHQ-9, BDI-II and GAD-7, respectively. Patients with milder symptoms require much larger reductions as percentage of their baseline to endorse improvement. CONCLUSIONS: An MCID representing 20% reduction of scores in these scales, is a useful guide for patients with moderately severe symptoms. If treatment had the same effect on patients irrespective of baseline severity, those with low symptoms are unlikely to notice a benefit. FUNDING: Funding. National Institute for Health Research.

Burden of HIV-related stigma and associated factors among women living with depression accessing PMTCT services in Dar es Salaam, Tanzania.

HIV-related stigma represents a potent risk factor for a range of poor health outcomes, including mental health symptoms, treatment non-adherence, and substance use. Understanding the role of HIV-related stigma in promoting healthcare outcomes is critical for vulnerable populations, such as pregnant women living with HIV, in contexts with continued high rates of HIV and associated stigma, such as sub-Saharan Africa. The current study examined a range of risk and protective factors for HIV-related stigma with 742 pregnant women (M age = 29.6 years) living with depression and HIV accessing prevention of mother-to-child transmission of HIV (PMTCT) services in Dar es Salaam, Tanzania. Risk factors included depressive symptoms, ART non-adherence, intimate partner violence, food insecurity, and alcohol problems. Protective factors included disclosure of HIV status, social support, an appreciative relationship with their partner, hope, and self-efficacy. Findings highlight key psychosocial and behavioral determinants of HIV-related stigma for pregnant women living with HIV in Tanzania, and can inform perinatal care programming and interventions to optimize mental health and adherence outcomes.

Depressive and subthreshold depressive symptomatology among older adults in a socioeconomically deprived area in Brazil.

Depressive and subthreshold depressive symptomatology are common but often neglected in older adults. OBJECTIVE: This study aimed to assess rates of depressive and subthreshold depressive symptomatology, and the characteristics associated, among older adults living in a socioeconomically deprived area of Brazil. METHODS: This study is part of the PROACTIVE cluster randomised controlled trial. 3356 adults aged 60+ years and registered in 20 primary health clinics were screened for depressive symptomatology with the Patient Health Questionnaire-9 (PHQ-9). Depressive status was classified according to the total PHQ-9 score and the presence of core depressive symptoms (depressed mood and anhedonia) as follows: no depressive symptomatology (PHQ-9 score 0-4, or 5-9 but with no core depressive symptom); subthreshold depressive symptomatology (PHQ-9 score 5-9 and at least one core depressive symptom); and depressive symptomatology (PHQ-9 score ≥ 10). Sociodemographic information and self-reported chronic conditions were collected. Relative risk ratios and 95% CIs were obtained using a multinomial regression model. RESULTS: Depressive and subthreshold depressive symptomatology were present in 30% and 14% of the screened sample. Depressive symptomatology was associated with female gender, low socioeconomic conditions and presence of chronic conditions, whereas subthreshold depressive symptomatology was only associated with female gender and having hypertension. CONCLUSIONS: Depressive and subthreshold depressive symptomatology is highly prevalent in this population registered with primary care clinics. Strategies managed by primary care non-mental health specialists can be a first step for improving this alarming and neglected situation among older adults.

Using the RE-AIM framework to evaluate the implementation of scaling-up the Friendship Bench in Zimbabwe - a quantitative observational study.

BACKGROUND: This study aimed to evaluate the real-world implementation of the Friendship Bench (FB) - an evidence-based brief psychological intervention delivered by community health workers (CHWs) - three years after its implementation in three city health departments in Zimbabwe. Implementation sites were evaluated according to their current performance using the RE-AIM framework making this one of the first evaluations of a scaled-up evidence-based psychological intervention in sub-Saharan Africa (SSA). METHODS: Using the RE-AIM guide ( www.re-aim.org ), the authors designed quantitative indicators based on existing FB implementation data. Thirty-six primary health care clinics (PHC) in Harare (n=28), Chitungwiza (n=4) and Gweru (n=4) were included. Among these clinics 20 were large comprehensive health care centers, 7 medium (mostly maternal and child healthcare) and 9 small clinics (basic medical care and acting as referral clinic). Existing data from these clinics, added to additionally collected data through interviews and field observations were used to investigate and compare the performance of the FB across clinics. The focus was on the RE-AIM domains of Reach, Adoption, and Implementation. RESULTS: Small clinics achieved 34% reach, compared to large (15%) and medium clinics (9%). Adoption was high in all clinic types, ranging from 59% to 71%. Small clinics led the implementation domain with 53%, followed by medium sized clinics 43% and large clinics 40%. Small clinics performed better in all indicators and differences in performance between small and large clinics were significant. Program activity and data quality depends on ongoing support for delivering agents and buy-in from health authorities. CONCLUSION: The Friendship Bench program was implemented over three years transitioning from a research-based implementation program to one led locally. The Reach domain showed the largest gap across clinics where larger clinics performed poorly relative to smaller clinics and should be a target for future implementation improvements. Program data needs to be integrated into existing health information systems. Future studies should seek to optimize scale-up and sustainment strategies to maintain effective task-shared psychological interventions in SSA.

Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis.

BACKGROUND: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. OBJECTIVE: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. METHODS: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. RESULTS: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (ß=.16, 95% CI -0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (ß=.49, 95% CI 0.22-0.76) but not for TAU (ß=-.23, 95% CI -0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (ß=.06, 95% CI -0.11 to 0.23) or 6-month (ß=.09, 95% CI -0.10 to 0.28) follow-up. CONCLUSIONS: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Psychometric properties of the PHQ-9 measure of depression among Brazilian older adults.

Objectives: To obtain evidence on the psychometric properties of the Patient Health Questionnaire - 9 (PHQ-9, one of the most extensively used tools for assessing depression) in the Brazilian older population.Method: Data on 3,356 Brazilian adults aged 60+ years living in Guarulhos, São Paulo state were used. The factor structure of the questionnaire was analysed using a factor analysis approach. The questionnaire's measurement equivalence was tested across gender, age, personal income, and education level groups. The scores were compared across groups based on the highest level of equivalence achieved. The questionnaire's internal consistency was analysed considering its factor structure.Results: A one-factor solution was identified as the most adequate factor structure, with the factor explaining 57.6% of the items' variance. The correlation of the resulting latent score with the overall raw sum score in the PHQ-9 was r = 0.96. Measurement equivalence regarding thresholds and loadings was achieved for all tested groups. On average, women, older, less educated, and poorer people had higher latent scores on the depression factor. The measure showed a good internal consistency with Revelle's omega total ωt=0.92.Conclusion: The results suggest that, among Brazilian older adults living in Guarulhos, São Paulo state, the PHQ-9 measures depressive symptomatology equivalently across different sociodemographic subgroups. Moreover, it can be scored using the raw sum of the item scores to adequately reflect different levels of depressive symptomatology.

Effectiveness of the KiVa Antibullying Program with and without the Online Game in Chile: a Three-Arm Cluster Randomized Controlled Trial.

Bullying is a major health problem. The KiVa antibullying program has been evaluated in Finland and other European countries, showing preventive effects on self-reported bullying victimization and perpetration. No evaluations of this program have been conducted in Latin America. A cluster randomized controlled trial was conducted at socially vulnerable schools in Santiago, Chile, to assess the effectiveness of the KiVa antibullying program in grades 5 and 6 (aged 10-12 years). Schools were randomly assigned (1:1:1) to three groups: the full KiVa group (including the online game), the partial KiVa group (did not include the online game), and the control group in which the regular school curriculum was implemented. The primary outcome was self-reported bullying victimization, assessed before the intervention (baseline) at the end of the academic year (November 2016) and post-intervention, 12 months after the baseline assessment (November 2017). This trial is registered with ClinicalTrials.gov, number NCT02898324. A total of 39 schools (13 in each group) were included; no schools withdrew. The baseline survey included 5923 participants, and the endpoint survey included 3968 participants. Participants in the partial KiVa group had lower bullying victimization at the endpoint survey than those in the control group (OBVQ-R adjusted mean difference - 0.14; 95% CI, - 0.26 to - 0.01; effect size - 0.13, 95% CI - 0.24 to - 0.01, p = 0.035). There was no effect of the full KiVa group for bullying victimization compared with the control and partial KiVa groups. Compared to the control group, participants in the partial KiVa group had lower witnessing bullying at school (adjusted mean difference = - 0.25; 95% CI - 0.45 to - 0.05; effect size - 0.18, 95% CI, - 0.32 to - 0.04, p = 0.013). No effects were found for other secondary outcomes, including bullying perpetration in any comparisons between arms. The implementation of the KiVa antibullying program had mixed results in Chile. There was only a small effect on bullying victimization and witnessing when KiVa was delivered without the online game.

An intervention to improve teacher well-being support and training to support students in UK high schools (the WISE study): A cluster randomised controlled trial.

BACKGROUND: Teachers are at heightened risk of poor mental health and well-being, which is likely to impact on the support they provide to students, and student outcomes. We conducted a cluster randomised controlled trial, to test whether an intervention to improve mental health support and training for high school teachers led to improved mental health and well-being for teachers and students, compared to usual practice. We also conducted a cost evaluation of the intervention. METHODS AND FINDINGS: The intervention comprised (i) Mental Health First Aid training for teachers to support students; (ii) a mental health awareness session; and (iii) a confidential staff peer support service. In total 25 mainstream, non-fee-paying secondary schools stratified by geographical area and free school meal entitlement were randomly allocated to intervention (n = 12) or control group (n = 13) after collection of baseline measures. We analysed data using mixed-effects repeated measures models in the intention-to-treat population, adjusted for stratification variables, sex, and years of experience. The primary outcome was teacher well-being (Warwick-Edinburgh Mental Well-being Scale). Secondary outcomes were teacher depression, absence, and presenteeism, and student well-being, mental health difficulties, attendance, and attainment. Follow-up was at months 12 (T1) and 24 (T2). We collected process data to test the logic model underpinning the intervention, to aid interpretation of the findings. A total of 1,722 teachers were included in the primary analysis. Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference -0.90, 95% CI -2.07 to 0.27, p = 0.130). The only effect on secondary outcomes was higher teacher-reported absence among the intervention group at T2 (intervention group median number of days absent 0, control group median number of days absent 0, ratio of geometric means 1.04, 95% CI 1.00 to 1.09, p = 0.042). Process measures indicated little change in perceived mental health support, quality of relationships, and work-related stress. The average cost of the intervention was £9,103 per school. The study's main limitations were a lack of blinding of research participants and the self-report nature of the outcome measures. CONCLUSIONS: In this study, we observed no improvements to teacher or student mental health following the intervention, possibly due to a lack of impact on key drivers of poor mental health within the school environment. Future research should focus on structural and cultural changes to the school environment, which may be more effective at improving teacher and student mental health and well-being. TRIAL REGISTRATION: www.isrctn.com ISRCTN95909211.

Effect of collaborative care between traditional and faith healers and primary health-care workers on psychosis outcomes in Nigeria and Ghana (COSIMPO): a cluster randomised controlled trial.

BACKGROUND: Traditional and faith healers (TFH) provide care to a large number of people with psychosis in many sub-Saharan African countries but they practise outside the formal mental health system. We aimed to assess the effectiveness and cost-effectiveness of a collaborative shared care model for psychosis delivered by TFH and primary health-care providers (PHCW). METHODS: In this cluster-randomised trial in Kumasi, Ghana and Ibadan, Nigeria, we randomly allocated clusters (a primary care clinic and neighbouring TFH facilities) 1:1, stratified by size and country, to an intervention group or enhanced care as usual. The intervention included a manualised collaborative shared care delivered by trained TFH and PHCW. Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60). The primary outcome, by masked assessments at 6 months, was the difference in psychotic symptom improvement as measured with the PANSS in patients in follow-up at 3 and 6 months. Patients exposure to harmful treatment practices, such as shackling, were also assessed at 3 and 6 months. Care costs were assessed at baseline, 3-month and 6-month follow-up, and for the entire 6 months of follow-up. This trial was registered with the National Institutes of Health Clinical Trial registry, NCT02895269. FINDINGS: Between Sept 1, 2016, and May 3, 2017, 51 clusters were randomly allocated (26 intervention, 25 control) with 307 patients enrolled (166 [54%] in the intervention group and 141 [46%] in the control group). 190 (62%) of participants were men. Baseline mean PANSS score was 107·3 (SD 17·5) for the intervention group and 108·9 (18·3) for the control group. 286 (93%) completed the 6-month follow-up at which the mean total PANSS score for intervention group was 53·4 (19·9) compared with 67·6 (23·3) for the control group (adjusted mean difference -15·01 (95% CI -21·17 to -8·84; 0·0001). Harmful practices decreased from 94 (57%) of 166 patients at baseline to 13 (9%) of 152 at 6 months in the intervention group (-0·48 [-0·60 to -0·37] p<0·001) and from 59 (42%) of 141 patients to 13 (10%) of 134 in the control group (-0·33 [-0·45 to -0·21] p<0·001), with no significant difference between the two groups. Greater reductions in overall care costs were seen in the intervention group than in the control group. At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group). Five patients in the intervention group had mild extrapyramidal side effects. INTERPRETATION: A collaborative shared care delivered by TFH and conventional health-care providers for people with psychosis was effective and cost-effective. The model of care offers the prospect of scaling up improved care to this vulnerable population in settings with low resources. FUNDING: US National Institute of Mental Health.

Preventing depression among older people living in rural areas: A randomised controlled trial of behavioural activation in collaborative care.

OBJECTIVES: This study aimed to test if a behavioural activation (BA) programme was more effective than usual care at reducing the risk of conversion to major depression over 52 weeks among adults aged 65 years or older living in rural Western Australia. Secondary aims were to test if participants assigned to the BA intervention experienced greater decline in the severity of depressive and anxiety symptoms than older adults treated with usual care over 26 and 52 weeks, as well as greater improvement in physical and mental health-related quality of life. METHODS: Randomised controlled clinical trial that started recruitment in February 2016 in rural Western Australia. We used the electoral roll to invite adults aged 65 years or over living in suitable regions of Western Australia to take part in the study. We recruited those who consented and screened positive to at least one of the two Whooley questions: feeling down/depressed/hopeless or little interest or pleasure over the past month. Participants were randomly assigned to usual care or usual care plus a phone-delivered BA program (1:1). The intervention consisted of a self-managed BA program supported by three 45-min phone sessions delivered by a BA therapist over a period of 8 weeks. We used the DSM-5 criteria to establish the presence of a major depressive episode, and Patient Health Questionnaire, Generalised Anxiety Disorder Scale and SF-36 to assess symptoms of depression, anxiety and quality of life. RESULTS: Of the 309 older adults randomised, 307 started the trial: 153 usual care and 154 BA (computer-generated random permuted even blocks ranging in size from 8 to 20). Six participants developed a major depressive episode during follow-up, four of them in the usual care group (odds ratio of depression associated with the intervention = 0.49, 95% CI = 0.04, 3.49-blind assessment). Seventy-three (23.8%) participants were lost over 52 weeks-there were no differences between usual care and intervention group. Intention-to-treat analyses using mixed regression models found modest non-significant effects of the BA intervention, while complete-case analyses showed that participants treated with BA compared with usual care experienced significant improvements in depression and anxiety symptoms over 52 weeks, as well as improved mental health quality of life. CONCLUSIONS: Few participants developed a major depressive episode during follow-up. The BA intervention was associated with improved symptoms of depression and anxiety, although the clinical significance of these benefits remains unclear.

A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial.

BACKGROUND: Depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile. METHODS: Two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item [PHQ-9] scores ≥15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at 3, 6, and 12 months after enrollment. The primary outcome will be depression improvement at 6 months, defined as ≥50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed. DISCUSSION: This study will be one of the first to provide evidence for the effectiveness of a collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care in a Latin American country. TRIAL REGISTRATION: retrospectively registered in ClinicalTrials.gov , first posted: November 3, 2020, under identifier: NCT04613076 .

Recruitment, training and supervision of nurses and nurse assistants for a task-shifting depression intervention in two RCTs in Brazil and Peru.

BACKGROUND: Task-shifting and technology in psychological interventions are two solutions to increasing access to mental health intervention and overcoming the treatment gap in low and middle-income countries. The CONEMO intervention combines a smartphone app with support from non-specialized professionals, aiming to treat depression in patients with diabetes and/or hypertension. The aim of this paper is to describe the process of recruitment, training and supervision of the non-specialized professionals who participated in the CONEMO task-shifting intervention in Brazil and Peru. METHODS: We described and analyzed data related to the recruitment, training and supervision of 62 nurse assistants from the health system in Sao Paulo, Brazil, and three hired nurses in Lima, Peru. The data were collected from information provided by nurses and nurse assistants, supervisor records from supervision meetings and the CONEMO platform database. RESULTS: We found that task-shifting was feasible using existing resources in Sao Paulo and additional human resources in Lima. Training and supervision were found to be crucial and well received by the staff; however, time was a limitation when using existing human resources. Ensuring technological competence prior to the start of the intervention was essential. Group supervision meetings allowed non-specialized professionals to learn from each other's experiences. CONCLUSION: Carefully considering recruitment, training and supervision of non-specialized professionals is important for effective task-shifting when delivering an mHealth intervention for depression. Opportunities and challenges of working in different health systems are described, which should be considered in future implementation, either for research or real settings. Trial registration NCT028406662 (Sao Paulo), NCT03026426 (Peru).

Acceptability and fidelity of a psychosocial intervention (PROACTIVE) for older adults with depression in a basic health unit in São Paulo, Brazil: a qualitative study.

BACKGROUND: Depression is a common condition in older adults, being often detected and treated initially in primary care. Collaborative care models including, for example, task-shifting and stepped-care approaches have been investigated to overcome the current scarcity of strategies and trained mental health professionals to treat depression. The PROACTIVE study developed a psychosocial intervention, which makes extensive use of technology in an intervention delivered mainly by non-specialists to treat older adults with depression. The aim of this qualitative study is to assess: 1. Health workers' fidelity to the intervention protocol; 2. Acceptability of the psychosocial intervention from the viewpoint of older adult participants; and 3. Perceptions of the psychosocial intervention by the health workers. METHODS: Qualitative methods were used to achieve our aims. The sample included participants (N = 31) receiving the intervention in the pilot trial and health workers (N = 11) working in a Basic Health Unit in the northern area of São Paulo, Brazil. Focus group, non-participant observation and structured interviews were used. Data were analysed using a thematic analysis approach. RESULTS: 1. Health workers' fidelity to the intervention protocol: training, supervision and the structured intervention were crucial and guaranteed health workers' fidelity to the protocol. 2. Acceptability of the psychosocial intervention from the viewpoint of older adult participants: Collaborative care, task-shifting, and stepped-care approaches were well accepted. The structured protocol of the intervention including different activities and videos was important to adherence of older adult participants 3. Perceptions of the psychosocial intervention by the health workers: It was feasible to have the home psychosocial sessions conducted by health workers, who are non-mental health specialists and received 3-day training. Training and supervision were perceived as crucial to support health workers before and during the intervention. Technology served as a tool to structure the sessions, obtain and store patient data, present multi-media content, guarantee fidelity to the protocol and facilitate communication among members of the team. However, extra burden was mentioned by the health workers indicating the need of adjustments in their daily duties. CONCLUSIONS: The PROACTIVE intervention was demonstrated to be feasible and accepted by both health workers and older adult participants. The qualitative assessments suggested improvements in training and supervision to ensure fidelity to protocol. To assess effectiveness a randomised controlled trial of the intervention will be conducted with the addition of improvements suggested by this qualitative study. TRIAL REGISTRATION: The pilot study of which the present study gives support to was registered at the Brazilian Clinical Trials, UTN code: U1111-1218-6717 on 26/09/2018.

Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials.

Importance: Depression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low- and middle-income countries, but the effectiveness in these countries is unknown. Objective: To investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension. Design, Setting, and Participants: Participants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018). Interventions: An 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima). Main Outcomes and Measures: The primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months. Results: Among 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant. Conclusions and Relevance: In 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months. Trial Registration: ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima).

Major Depressive Disorder Among HIV Infected Youth in Uganda: Incidence, Persistence and Their Predictors.

Incidence and persistence of major depressive disorder (MDD) in children and adolescents with HIV (CA-HIV) in Uganda is described. 1339 CA-HIV attending care were enrolled and followed up for 12 months. MDD was assessed using the DSM-5 referenced Child and Adolescent Symptom Inventory-5 (CASI-5), with a prevalence for MDD at baseline of 5% (95% CI 3.3-7.3). Kaplan-Meir method was used to estimate incidence of MDD and Cox models were fitted to investigate predictors of incident MDD. Cumulative incidence of MDD over 12 months was 7.6 per 100 person-years 95% CI (6.2-9.4) and a rate of persistent MDD of 10/105 (9.5% CI 3.9-15.1). Significant independent predictors of incident MDD were: highest educational level of CA-HIV (protective), increasing depressive scores and decreasing CD4 Nadir. These finding have implications for what should constitute components of a mental health integration model in HIV youth services and for the future development of individualised mental health care.