Do baseline characteristics affect depressive symptoms treatment success? Posthoc subgroup analysis from the CONEMO.

OBJECTIVE: As a secondary trial plan analysis, we aim to examine whether participant characteristics, measured before randomization, modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO - Emotional Control) on recovery from depression that has presented a substantive impact on previous research. METHOD: Mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest, including suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension). 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 the scores of depressive symptoms in at least 50% at three-month follow-up) were observed amongst older and wealthier participants in Lima (p-values 0.030 and 0.001, respectively). At the same time, there was no evidence of such differential effects in São Paulo or any other secondary outcomes level in both countries. CONCLUSIONS: Digital intervention used in primary care settings needs to be accessible. We conclude that the technological intervention CONEMO has no heterogeneity effects on most subgroups studied, except income and age in the Lima trial.

A Mobile Health Intervention for Patients With Depressive Symptoms: Protocol for an Economic Evaluation Alongside Two Randomized Trials in Brazil and Peru.

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.

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).

Chatbot-Based Assessment of Employees' Mental Health: Design Process and Pilot Implementation.

BACKGROUND: Stress, burnout, and mental health problems such as depression and anxiety are common, and can significantly impact workplaces through absenteeism and reduced productivity. To address this issue, organizations must first understand the extent of the difficulties by mapping the mental health of their workforce. Online surveys are a cost-effective and scalable approach to achieve this but typically have low response rates, in part due to a lack of interactivity. Chatbots offer one potential solution, enhancing engagement through simulated natural human conversation and use of interactive features. OBJECTIVE: The aim of this study was to explore if a text-based chatbot is a feasible approach to engage and motivate employees to complete a workplace mental health assessment. This paper describes the design process and results of a pilot implementation. METHODS: A fully automated chatbot ("Viki") was developed to evaluate employee risks of suffering from depression, anxiety, stress, insomnia, burnout, and work-related stress. Viki uses a conversation style and gamification features to enhance engagement. A cross-sectional analysis was performed to gain first insights of a pilot implementation within a small to medium-sized enterprise (120 employees). RESULTS: The response rate was 64.2% (77/120). In total, 98 employees started the assessment, 77 of whom (79%) completed it. The majority of participants scored in the mild range for anxiety (20/40, 50%) and depression (16/28, 57%), in the moderate range for stress (10/22, 46%), and at the subthreshold level for insomnia (14/20, 70%) as defined by their questionnaire scores. CONCLUSIONS: A chatbot-based workplace mental health assessment seems to be a highly engaging and effective way to collect anonymized mental health data among employees with response rates comparable to those of face-to-face interviews.

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).

High variability in the measurement of HIV primary prevention activities and outcomes.

INTRODUCTION: While there is a global consensus on monitoring Human Immunodeficiency Virus (HIV) treatment progress, there has been less attention to the degree of consistency of the measurement of HIV prevention programmes-and the global prevention response is not on-track to achieve 2020 goals. In this paper, we assess the degree of variability in primary prevention indicators selected by national strategic plans (NSPs) and global stakeholder monitoring and evaluation (M&E) strategies. METHODS: We obtained the most recent NSPs from low and middle income Joint United Nations Programme on HIV/AIDS (UNAIDS) Fast-Track countries, and M&E documents from The Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund), President's Emergency Plan for AIDS Relief (PEPFAR), UNAIDS, the Global HIV Prevention Coalition and the World Health Organization (WHO). We extracted HIV primary prevention indicators from each document, standardized and aggregated them by age/ sex, categorized indicators by topic, and evaluated the frequency of matched indicators between countries and stakeholders. Data were collected between February and April of 2019. RESULTS: Twenty-one NSPs and five global stakeholder documents were assessed; 736 primary prevention indicators were identified; 284 remained following standardization and aggregation. NSPs contained from 3 to 48 primary prevention indicators, with an average of 23; categories included: HIV education and outreach (17.6%), testing (17.3%) and condom use (16.2%). Of unique national indicators, only 34% was shared between two or more countries. Sixty-nine per cent was applied in a single country only. 56% of NSP indicators did not appear in any global stakeholder document. Conversely, 42% of global indicators did not appear in any surveyed NSPs. Within global indicators, 63% was only measured by one global body, and no single indicator was measured by all five. CONCLUSIONS: These analyses reveal a lack of consensus both between and within countries' and global stakeholders' measurement of HIV prevention. Though some variability is expected, these findings point to a need to refocus attention on achieving greater consensus on a global measurement framework for HIV prevention.

Preliminary Evaluation of the Engagement and Effectiveness of a Mental Health Chatbot.

Background: Mental health difficulties are highly prevalent, yet access to support is limited by barriers of stigma, cost, and availability. These issues are even more prevalent in low- and middle-income countries, and digital technology is one potential way to overcome these barriers. Digital mental health interventions are effective but often struggle with low engagement rates, particularly in the absence of human support. Chatbots could offer a scalable solution, simulating human support at a lower cost. Objective: To complete a preliminary evaluation of engagement and effectiveness of Vitalk, a mental health chatbot, at reducing anxiety, depression and stress. Methods: Real world data was analyzed from 3,629 Vitalk users who had completed the first phase of a Vitalk program ("less anxiety," "less stress" or "better mood"). Programs were delivered through written conversation with a chatbot. Engagement was calculated from the number of responses sent to the chatbot divided by days in the program. Results: Users sent an average of 8.17 responses per day. For all three programs, target outcome scores reduced between baseline and follow up with large effect sizes for anxiety (Cohen's d = -0.85), depression (Cohen's d = -0.91) and stress (Cohen's d = -0.81). Increased engagement resulted in improved post-intervention values for anxiety and depression. Conclusion: This study highlights a chatbot's potential to reduce mental health symptoms in the general population within Brazil. While findings show promise, further research is required.

'Jumping to conclusions' in first-episode psychosis: a longitudinal study.

OBJECTIVES: People with psychotic symptoms are reported to have a characteristic reasoning style in which they jump to conclusions. To date, little research has been conducted to investigate if this style changes over time and is associated with improvements or worsening of symptoms. This study considered these questions. METHODS: Thirty-one service users were recruited from a first-episode service and completed measures of reasoning, psychotic, and non-psychotic symptomatology at two time points over 2 years. RESULTS: Over time, people with psychosis generally became less hasty in their decision-making. Those who became less hasty in their reasoning were less symptomatic. For those who remained very hasty in their reasoning, this was associated with a worsening specifically of the delusional beliefs. CONCLUSIONS: This work supports the notion that there is a critical time in the first few years of psychosis during which symptoms and reasoning can change. However, where reasoning style does not change, this may be associated with greater difficulties associated with delusional beliefs.