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OBJECTIVE: To ascertain whether sociodemographic and health-related characteristics known from previous research to have a substantive impact on recovery from depression modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO). METHODS: The CONEMO study consisted of two randomized controlled trials, one conducted in Lima, Peru, and one in São Paulo, Brazil. As a secondary trial plan analysis, mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest defined by characteristics measured before randomization - suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension - in both trials. We estimated interaction effects between the treatment group and these subgroup factors for the secondary outcomes using linear mixed regression models. RESULTS: Increased effects of the CONEMO intervention on the primary outcome (reduction of at least 50% in depressive symptom scores at 3-month follow-up) were observed among older and wealthier participants in the Lima trial (p = 0.030 and p = 0.001, respectively). CONCLUSION: There was no evidence of such differential effects in São Paulo, and no evidence of impact of any other secondary outcomes in either trial. CLINICAL TRIAL REGISTRATION: NCT02846662 (São Paulo, Brazil - SP), NCT03026426 (Lima, Peru - LI).

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Objective: To ascertain whether sociodemographic and health-related characteristics known from previous research to have a substantive impact on recovery from depression modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO). Methods: The CONEMO study consisted of two randomized controlled trials, one conducted in Lima, Peru, and one in São Paulo, Brazil. As a secondary trial plan analysis, mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest defined by characteristics measured before randomization - suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension - in both trials. We estimated interaction effects between the treatment group and these subgroup factors for the secondary outcomes using linear mixed regression models. Results: Increased effects of the CONEMO intervention on the primary outcome (reduction of at least 50% in depressive symptom scores at 3-month follow-up) were observed among older and wealthier participants in the Lima trial (p = 0.030 and p = 0.001, respectively). Conclusion: There was no evidence of such differential effects in São Paulo, and no evidence of impact of any other secondary outcomes in either trial. Clinical trial registration: NCT02846662 (São Paulo, Brazil - SP), NCT03026426 (Lima, Peru - LI). Funded by the U.S. National Institute of Mental Health (grant U19MH098780).

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BACKGROUND: Mobile health interventions provide significant strategies for improving access to health services, offering a potential solution to reduce the mental health treatment gap. Economic evaluation of this intervention is needed to help inform local mental health policy and program development. OBJECTIVE: This paper presents the protocol for an economic evaluation conducted alongside 2 randomized controlled trials (RCTs) to evaluate the cost-effectiveness of a psychological intervention delivered through a technological platform (CONEMO) to treat depressive symptoms in people with diabetes, hypertension, or both. METHODS: The economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO plus enhanced usual care in comparison with enhanced usual care from public health care system and societal perspectives. Participants are patients of the public health care services for hypertension, diabetes, or both conditions in São Paulo, Brazil (n=880) and Lima, Peru (n=432). Clinical effectiveness will be measured by reduction in depressive symptoms and gains in health-related quality of life. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost per at least 50% reduction in 9-item Patient Health Questionnaire scores, and cost per quality-adjusted life year gained. The measurement of clinical effectiveness and resource use will take place over baseline, 3-month follow-up, and 6-month follow-up in the intervention and control groups. We will use a mixed costing methodology (ie, a combination of top-down and bottom-up approaches) considering 4 cost categories: intervention (CONEMO related) costs, health care costs, patient and family costs, and productivity costs. We will collect unit costs from the RCTs and national administrative databases. The multinational economic evaluations will be fully split analyses with a multicountry costing approach. We will calculate incremental cost-effectiveness ratios and present 95% CIs from nonparametric bootstrapping (1000 replicates). We will perform deterministic and probabilistic sensitivity analyses. Finally, we will present cost-effectiveness acceptability curves to compare a range of possible cost-effectiveness thresholds. RESULTS: The economic evaluation project had its project charter in June 2018 and is expected to be completed in September 2021. The final results will be available in the second half of 2021. CONCLUSIONS: We expect to assess whether CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared with enhanced usual care. This study will contribute to the evidence base for health managers and policy makers in allocating additional resources for mental health initiatives. It also will provide a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT12345678 (Brazil) and NCT03026426 (Peru); https://clinicaltrials.gov/ct2/show/NCT02846662 and https://clinicaltrials.gov/ct2/show/NCT03026426. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26164.

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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).

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BACKGROUND: Depression is underdiagnosed and undertreated in primary health care. When associated with chronic physical disorders, it worsens outcomes. There is a clear gap in the treatment of depression in low- and middle-income countries (LMICs), where specialists and funds are scarce. Interventions supported by mobile health (mHealth) technologies may help to reduce this gap. Mobile phones are widely used in LMICs, offering potentially feasible and affordable alternatives for the management of depression among individuals with chronic disorders. OBJECTIVE: This study aimed to explore the potential effectiveness of an mHealth intervention to help people with depressive symptoms and comorbid hypertension or diabetes and explore the feasibility of conducting large randomized controlled trials (RCTs). METHODS: Emotional Control (CONEMO) is a low-intensity psychoeducational 6-week intervention delivered via mobile phones and assisted by a nurse for reducing depressive symptoms among individuals with diabetes or hypertension. CONEMO was tested in 3 pilot studies, 1 in São Paulo, Brazil, and 2 in Lima, Peru. Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9) at enrollment and at 6-week follow-up. RESULTS: The 3 pilot studies included a total of 66 people. Most participants were females aged between 41 and 60 years. There was a reduction in depressive symptoms as measured by PHQ-9 in all pilot studies. In total, 58% (38/66) of the participants reached treatment success rate (PHQ-9 <10), with 62% (13/21) from São Paulo, 62% (13/21) from the first Lima pilot, and 50% (12/24) from the second Lima pilot study. The intervention, the app, and the support offered by the nurse and nurse assistants were well received by participants in both settings. CONCLUSIONS: The intervention was feasible in both settings. Clinical data suggested that CONEMO may help in decreasing participants' depressive symptoms. The findings also indicated that it was possible to conduct RCTs in these settings.

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BACKGROUND: Emerging researchers in low- and middle-income countries (LMIC) face many barriers, including inadequacies in funding, international exposure and mentorship. In 2012, the National Institute of Mental Health (NIMH) funded five research hubs aimed at improving the research core for evidence-based mental health interventions, enhancing research skills in global mental health, and providing capacity building (CB) opportunities for early career investigators in LMIC. In this paper emerging researchers contextualize their experiences. CASE PRESENTATION: Each of the five hubs purposively selected an emerging researcher who had experienced more than one hub-related CB opportunity and actively participated in hub-related clinical trial activities. The five 'voices' were invited to contribute narratives on their professional backgrounds, CB experience, challenges and successes as an emerging mental health researcher, and suggestions for future CB activities. These narratives are presented as case studies. CB activities provided broader learning opportunities for emerging researchers. Benefits included the receipt of research funding, hands-on training and mentorship, as well as exposure to networks and collaborative opportunities on a global scale. To overcome ongoing challenges of access to funding, mentoring, networking and global exposure, the emerging voices recommend making mentorship and training opportunities available to a wider range of emerging mental health researchers. CONCLUSIONS: Investing in CB is not enough to ensure sustainability and leave a legacy unless it is accompanied by ongoing mentorship and international exposure. Financial investment in building research capacity, promotion of mentorship and supervision, and international networking are essential to yield well-prepared young investigators in LMIC as experienced by these rising stars. Governments and policymakers should prioritize educational policies to support the continuous development and international engagement of emerging researchers. This can advance strategies to deal with one of most important and costly problems faced by healthcare systems in LMIC: the mental health treatment gap.

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OBJECTIVE: To assess the relationship between indicators of socioeconomic status and cesarean section in public hospitals that adopt standardized protocols of obstetrical care. METHODS: This was a prospective cohort study conducted between May 2005 and January 2006 with 831 pregnant women recruited from 10 public primary care clinics in São Paulo, Brazil. Demographic and clinical characteristics were collected during pregnancy. The three main exposures were schooling, monthly family income per capita, and residential crowding. The main outcome was cesarean section at three public hospitals located in the area. Crude and adjusted risk ratios (RR), with 95% confidence intervals were calculated using Poisson regression with robust variance. We examined the effects of each exposure variable on cesarean section accounting for potential confounders by using four different models: crude, adjusted by mother's characteristics, by obstetrical complications, and by the other two indicators of socioeconomic status. RESULTS: Among the 757 deliveries performed in the public hospitals, 215 (28.4%) were by cesarean section. In the bivariate analysis, cesarean section was associated with higher family income per capita, higher education, lower residential crowding, pregnancy planning, white skin color, having a partner, and advanced maternal age. In the multivariate analysis, after adjustment for covariates, none of the socioeconomic status variables remained associated with cesarean section. CONCLUSIONS: In this group, the chance of women undergoing cesarean section was not associated with indicators of socioeconomic status only, but was defined in accordance with major obstetric and clinical conditions.

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PURPOSE: to evaluate the relationship between unplanned pregnancy (UP), a common problem in high and low income countries and maternal depression (MD). METHODS: Secondary analysis of data from a prospective cohort study with pregnant women recruited from 10 primary care clinics of the public sector in São Paulo, Brazil. Participants were questioned about pregnancy intention at 20-30 weeks of gestation. The Self Report Questionnaire score >7 was used to evaluated the presence of depression during pregnancy and 11 months after childbirth. Four groups of MD were defined: never; antenatal only; postnatal only; persistent (both antenatal/postnatal). Multinomial logistic regression was used to assess the relationship between UP and MD, controlling for confounding. RESULTS: Data were analysed for 701 at the postpartum period. Five hundred and sixty-two (67.8%) women did not plan the pregnancy. Women with UP had 2.5 more risk of being depressed during both assessments (during pregnancy and postpartum) when compared to women with a planned pregnancy (RR: 2.5; 95% CI: 1.47:4.30). In the adjusted models, women with UP were significantly more likely to have persistent depression (RR: 2.3; 95% CI: 1.2:4.3). CONCLUSION: UP is an independent risk factor for persistent depression, but not for postpartum depression.

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ABSTRACT OBJECTIVE To assess the relationship between indicators of socioeconomic status and cesarean section in public hospitals that adopt standardized protocols of obstetrical care. METHODS This was a prospective cohort study conducted between May 2005 and January 2006 with 831 pregnant women recruited from 10 public primary care clinics in São Paulo, Brazil. Demographic and clinical characteristics were collected during pregnancy. The three main exposures were schooling, monthly family income per capita, and residential crowding. The main outcome was cesarean section at three public hospitals located in the area. Crude and adjusted risk ratios (RR), with 95% confidence intervals were calculated using Poisson regression with robust variance. We examined the effects of each exposure variable on cesarean section accounting for potential confounders by using four different models: crude, adjusted by mother’s characteristics, by obstetrical complications, and by the other two indicators of socioeconomic status. RESULTS Among the 757 deliveries performed in the public hospitals, 215 (28.4%) were by cesarean section. In the bivariate analysis, cesarean section was associated with higher family income per capita, higher education, lower residential crowding, pregnancy planning, white skin color, having a partner, and advanced maternal age. In the multivariate analysis, after adjustment for covariates, none of the socioeconomic status variables remained associated with cesarean section. CONCLUSIONS In this group, the chance of women undergoing cesarean section was not associated with indicators of socioeconomic status only, but was defined in accordance with major obstetric and clinical conditions.

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BACKGROUND: The rates of receipt of postnatal care vary widely between high and low-middle income countries. This study aimed to examine the association between indicators of socioeconomic status during pregnancy and gynecological appointment at any time after childbirth (GA). METHODS: a prospective cohort study with pregnant women recruited from 10 primary care clinics of the public sector in the city of São Paulo, Brazil. Socioeconomic characteristics and obstetric information were obtained through a questionnaire administered during pregnancy and in the postpartum period. Adjusted risk ratios (RR) with 95% confidence intervals (CI) were calculated using Poisson regression. RESULTS: Eight hundred and thirty one pregnant women were included in the study during the antenatal period and 701 were re-assessed during the postnatal period. Among them, 283 (59.6) attended a gynecological consultation. After adjusting for covariates, higher socioeconomic status during pregnancy was associated with greater risk of having a GA (RR:1.23, CI 95%:1.05:1.45 for family per capita monthly income; RR:1.19, CI 95 % 1.01:1.40 for asset score). CONCLUSION: In this sample, the attendance for GA was above average and women with higher socio-economic status were more likely to have receipt of such care. Special efforts should be made to improve the attendance and frequency of gynecological consultations after childbirth among poorer women.

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