Participants' and Nurses' Experiences With a Digital Intervention for Patients With Depressive Symptoms and Comorbid Hypertension or Diabetes in Peru: Qualitative Post-Randomized Controlled Trial Study.

BACKGROUND: Depression is one of the most prevalent mental disorders and a leading cause of disability, disproportionately affecting specific groups, such as patients with noncommunicable diseases. Over the past decade, digital interventions have been developed to provide treatment for these patients. CONEMO (Emotional Control in Spanish) is an 18-session psychoeducational digital intervention delivered through a smartphone app and minimally supported by a nurse. CONEMO demonstrated effectiveness in reducing depressive symptoms through a randomized controlled trial (RCT) among patients with diabetes, hypertension, or both, in Lima, Peru. However, in addition to clinical outcomes, it is important to explore users' experiences, satisfaction, and perceptions of usability and acceptability, which can affect their engagement with the intervention. OBJECTIVE: This study aimed to explore the RCT participants' experiences with CONEMO in Peru, complemented with information provided by the nurses who monitored them. METHODS: In 2018, semistructured interviews were conducted with a sample of 29 (13.4%) patients from the 217 patients who participated in the CONEMO intervention in Peru and the 3 hired nurses who supported its delivery. Interviewees were selected at random based on their adherence to the digital intervention (0-5, 10-14, and 15-18 sessions completed), to include different points of view. Content analysis was conducted to analyze the interviews. RESULTS: Participants' mean age was 64.4 (SD 8.5) years, and 79% (23/29) of them were women. Most of the interviewed participants (21/29, 72%) stated that CONEMO fulfilled their expectations and identified positive changes in their physical and mental health after using it. Some of these improvements were related to their thoughts and feelings (eg, think differently, be more optimistic, and feel calmer), whereas others were related to their routines (eg, go out more and improve health-related habits). Most participants (19/29, 66%) reported not having previous experience with using smartphones, and despite experiencing some initial difficulties, they managed to use CONEMO. The most valued features of the app were the videos and activities proposed for the participant to perform. Most participants (27/29, 93%) had a good opinion about the study nurses and reported feeling supported by them. A few participants provided suggestions to improve the intervention, which included adding more videos, making the sessions' text simple, extending the length of the intervention, and improving the training session with long explanations. CONCLUSIONS: The findings of this qualitative study provide further support and contextualize the positive results found in the CONEMO RCT, including insights into the key features that made the intervention effective and engaging. The participants' experience with the smartphone and CONEMO app reveal that it is feasible to be used by people with little knowledge of technology. In addition, the study identified suggestions to improve the CONEMO intervention for its future scale-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT03026426; https://clinicaltrials.gov/ct2/show/NCT03026426.

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).

Addressing Depression Comorbid With Diabetes or Hypertension in Resource-Poor Settings: A Qualitative Study About User Perception of a Nurse-Supported Smartphone App in Peru.

BACKGROUND: Smartphone apps could constitute a cost-effective strategy to overcome health care system access barriers to mental health services for people in low- and middle-income countries. OBJECTIVE: The aim of this paper was to explore the patients' perspectives of CONEMO (Emotional Control, in Spanish: Control Emocional), a technology-driven, psychoeducational, and nurse-supported intervention delivered via a smartphone app aimed at reducing depressive symptoms in people with diabetes, hypertension or both who attend public health care centers, as well as the nurses' feedback about their role and its feasibility to be scaled up. METHODS: This study combines data from 2 pilot studies performed in Lima, Peru, between 2015 and 2016, to test the feasibility of CONEMO. Interviews were conducted with 29 patients with diabetes, hypertension or both with comorbid depressive symptoms who used CONEMO and 6 staff nurses who accompanied the intervention. Using a content analysis approach, interview notes from patient interviews were transferred to a digital format, coded, and categorized into 6 main domains: the perceived health benefit, usability, adherence, user satisfaction with the app, nurse's support, and suggestions to improve the intervention. Interviews with nurses were analyzed by the same approach and categorized into 4 domains: general feedback, evaluation of training, evaluation of study activities, and feasibility of implementing this intervention within the existing structures of health system. RESULTS: Patients perceived improvement in their emotional health because of CONEMO, whereas some also reported better physical health. Many encountered some difficulties with using CONEMO, but resolved them with time and practice. However, the interactive elements of the app, such as short message service, android notifications, and pop-up messages were mostly perceived as challenging. Satisfaction with CONEMO was high, as was the self-reported adherence. Overall, patients evaluated the nurse accompaniment positively, but they suggested improvements in the technological training and an increase in the amount of contact. Nurses reported some difficulties in completing their tasks and explained that the CONEMO intervention activities competed with their everyday work routine. CONCLUSIONS: Using a nurse-supported smartphone app to reduce depressive symptoms among people with chronic diseases is possible and mostly perceived beneficial by the patients, but it requires context-specific adaptations regarding the implementation of a task shifting approach within the public health care system. These results provide valuable information about user feedback for those building mobile health interventions for depression.

Use of a Mobile Phone App to Treat Depression Comorbid With Hypertension or Diabetes: A Pilot Study in Brazil and Peru.

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.

Towards sustainable partnerships in global health: the case of the CRONICAS Centre of Excellence in Chronic Diseases in Peru.

Human capital requires opportunities to develop and capacity to overcome challenges, together with an enabling environment that fosters critical and disruptive innovation. Exploring such features is necessary to establish the foundation of solid long-term partnerships. In this paper we describe the experience of the CRONICAS Centre of Excellence in Chronic Diseases, based at Universidad Peruana Cayetano Heredia in Lima, Peru, as a case study for fostering meaningful and sustainable partnerships for international collaborative research. The CRONICAS Centre of Excellence in Chronic Diseases was established in 2009 with the following Mission: "We support the development of young researchers and collaboration with national and international institutions. Our motivation is to improve population's health through high quality research." The Centre's identity is embedded in its core values - generosity, innovation, integrity, and quality- and its trajectory is a result of various interactions between multiple individuals, collaborators, teams, and institutions, which together with the challenges confronted, enables us to make an objective assessment of the partnership we would like to pursue, nurture and support. We do not intend to provide a single example of a successful partnership, but in contrast, to highlight what can be translated into opportunities to be faced by research groups based in low- and middle-income countries, and how these encounters can provide a strong platform for fruitful and sustainable partnerships. In defiant contexts, partnerships require to be nurtured and sustained. Acknowledging that all partnerships are not and should not be the same, we also need to learn from the evolution of such relationships, its key successes, hurdles and failures to contribute to the promotion of a culture of global solidarity where mutual goals, mutual gains, as well as mutual responsibilities are the norm. In so doing, we will all contribute to instil a new culture where expectations, roles and interactions among individuals and their teams are horizontal, the true nature of partnerships.

The Latin American treatment and innovation network in mental health h (LATINMH): rationale and scope.

UNLABELLED: Over the past 60 years Latin American countries have been experiencing noticeable demographic and socioeconomic changes, with marked impact on the population health in the region. There is growing recognition of the co-morbidity among mental and physical health problems impacting heavily on health care systems. These challenges open many opportunities for transformational change in the expanding field of global mental health. Given the growing evidence for the wide applicability and efficacy of specific components included in mental health treatment packages, research should focus more on improving the organization and efficiency with which we deliver these specific treatment components already proven to be efficacious. The Latin American Treatment and Innovation Network in Mental Health (LATIN-MH) is a research and training Hub based in Sao Paulo, Brazil, and Lima, Peru. It aims to address the co-morbidity between physical and mental chronic diseases, exploring the opportunity to use technology to support the treatment of these conditions. LATIN-MH strives to move beyond specific single-disease approaches and research silos, whilst maximizing the opportunities to work collaboratively with various groups in the Latin American region, thus contributing to fostering research and building capacity in mental health research. KEY WORDS: Mental Health, Chronic Disease, mHealth, Capacity Building (MeSH) Key concepts: Chronic diseases have now become the major determinants of the disease burden in Latin America, whereas psychiatric disorders accounted for almost one-third of years lived with disability worldwide in 2005. LATIN-MH is a research and training hub that aims to address the co-morbidity between physical and mental chronic diseases using technology to support their treatments. LATIN-MH strives to move beyond specific single-disease approaches and research siloes, whilst maximizing the opportunities to work collaboratively with various groups in the Latin American region, thus contributing to foster research and build capacity in mental health research. LATIN-MH is built on three driving principles: (i) building capacities to ensure sustainability and autonomy of mental health services, (ii) developing strategic interdisciplinary partnerships, and (iii) integrating mental health treatment into primary care and community health systems.

Phylodynamic analysis of clinical and environmental Vibrio cholerae isolates from Haiti reveals diversification driven by positive selection.

UNLABELLED: Phylodynamic analysis of genome-wide single-nucleotide polymorphism (SNP) data is a powerful tool to investigate underlying evolutionary processes of bacterial epidemics. The method was applied to investigate a collection of 65 clinical and environmental isolates of Vibrio cholerae from Haiti collected between 2010 and 2012. Characterization of isolates recovered from environmental samples identified a total of four toxigenic V. cholerae O1 isolates, four non-O1/O139 isolates, and a novel nontoxigenic V. cholerae O1 isolate with the classical tcpA gene. Phylogenies of strains were inferred from genome-wide SNPs using coalescent-based demographic models within a Bayesian framework. A close phylogenetic relationship between clinical and environmental toxigenic V. cholerae O1 strains was observed. As cholera spread throughout Haiti between October 2010 and August 2012, the population size initially increased and then fluctuated over time. Selection analysis along internal branches of the phylogeny showed a steady accumulation of synonymous substitutions and a progressive increase of nonsynonymous substitutions over time, suggesting diversification likely was driven by positive selection. Short-term accumulation of nonsynonymous substitutions driven by selection may have significant implications for virulence, transmission dynamics, and even vaccine efficacy. IMPORTANCE: Cholera, a dehydrating diarrheal disease caused by toxigenic strains of the bacterium Vibrio cholerae, emerged in 2010 in Haiti, a country where there were no available records on cholera over the past 100 years. While devastating in terms of morbidity and mortality, the outbreak provided a unique opportunity to study the evolutionary dynamics of V. cholerae and its environmental presence. The present study expands on previous work and provides an in-depth phylodynamic analysis inferred from genome-wide single nucleotide polymorphisms of clinical and environmental strains from dispersed geographic settings in Haiti over a 2-year period. Our results indicate that even during such a short time scale, V. cholerae in Haiti has undergone evolution and diversification driven by positive selection, which may have implications for understanding the global clinical and epidemiological patterns of the disease. Furthermore, the continued presence of the epidemic strain in Haitian aquatic environments has implications for transmission.