Remote coaching for supporting the implementation of treatment for depression in primary care in Madhya Pradesh, India: protocol for a cluster randomized controlled trial.

Background: Upwards of ninety percent of individuals living with depression in India do not have access to evidence-based treatments, especially in rural areas. Integrating these treatments into primary care is essential for bridging this care gap. This trial aims to evaluate whether a remote coaching implementation support strategy, referred to as Enhanced Implementation Support, is superior to routine support, referred to as Routine Implementation Support, in supporting the delivery of collaborative depression care in rural primary care centers. Methods: Employing a cluster-randomized hybrid type-III implementation trial design, 14 primary care facilities in Sehore district, Madhya Pradesh, will implement a collaborative depression care package based on the WHO's mhGAP program. Facilities will be randomized to either Enhanced Implementation Support or the Routine Implementation Support control condition. Enhanced Implementation Support consists of remote coaching and technical assistance, supplemented with in-person visits, and guided by the Plan-Do-Study-Act implementation cycles. The primary implementation outcome is the proportion of outpatients screened for depression by facility staff, with secondary outcomes including the proportions of outpatients who screen positive for depression, are referred to the medical officer, and initiate treatment. Secondary patient outcomes include proportion of patients who achieve reduction in depression symptom severity at 3-month follow up. Acceptability, feasibility, and fidelity of the depression care package will be assessed through routine observations collected during field visits, facility audits, and qualitative exit interviews with facility staff. Costs of delivering the Enhanced Implementation Support strategy will also be estimated. Discussion: This trial can inform efforts to integrate depression care in rural primary care facilities in a low-resource setting, and illuminate whether external coaching support is superior relative to existing implementation support for achieving these goals. Trial Registration: NCT05264792.

A character-strengths based coaching intervention to improve wellbeing of rural community health workers in Madhya Pradesh, India: Protocol for a single-blind randomized controlled trial.

Background: There is scarce knowledge on the use of structured positive psychology interventions for reducing work-stress and improving wellbeing of rural community health workers in India, particularly the Accredited Social Health Activists (ASHAs) who are village-level (resident women, incentivised) lay health workers. This trial will test the effectiveness of a 'character-strengths' based coaching intervention compared to routine supervision on wellbeing ('authentic happiness') of ASHAs. Methods: This protocol is for a single-blind, parallel group randomized controlled trial comparing the effectiveness of a five-day residential workshop focusing on the use of character-strengths and subsequent 8- to 10-week remote telephonic coaching (weekly) to individually support ASHAs to improve their wellbeing, against routine health system support. The arms are intervention added to routine ASHA supervision (weekly, by the ASHA supervisor), and routine supervision alone (control arm). The target sample comprises 330 rural ASHAs in Madhya Pradesh, India. The primary outcome of mean Authentic Happiness Inventory (AHI) scores will be compared between arms at 3-month follow-up. Secondary outcomes will include an assessment of ASHA's self-reported affect, self-efficacy, flourishing, burnout, motivation, physical health symptoms, quality of life, and routine work performance indicators, and the consequent patient-level outcomes [e.g., service satisfaction and depression remission rates after receiving brief psychological treatment by trained ASHAs]. We will also evaluate the costs of developing and delivering the intervention. Discussion: This trial will determine whether a character-strengths based coaching intervention is an effective and scalable approach for reducing work-stress and improving wellbeing of rural ASHAs in low-resource settings.

Erratum: Scaling up the task-sharing of psychological therapies: A formative study of the PEERS smartphone application for supervision and quality assurance in rural India - CORRIGENDUM.

[This corrects the article DOI: 10.1017/gmh.2024.11.].

Digital phenotyping correlates of mobile cognitive measures in schizophrenia: A multisite global mental health feasibility trial.

Traditional cognitive assessments in schizophrenia are time-consuming and necessitate specialized training, making routine evaluation challenging. To overcome these limitations, this study investigates the feasibility and advantages of utilizing smartphone-based assessments to capture both cognitive functioning and digital phenotyping data and compare these results to gold standard measures. We conducted a secondary analysis of data from 76 individuals with schizophrenia, who were recruited across three sites (one in Boston, two in India) was conducted. The open-source mindLAMP smartphone app captured digital phenotyping data and Trails A/B assessments of attention / memory for up to 12 months. The smartphone-cognitive tasks exhibited potential for normal distribution and these scores showed small but significant correlations with the results from the Brief Assessment of Cognition in Schizophrenia, especially the digital span and symbol coding tasks (r2 = 0.21). A small but significant correlation (r2 = 0.29) between smartphone-derived cognitive scores and health-related behaviors such as sleep duration patterns was observed. Smartphone-based cognitive assessments show promise as cross-cultural tools that can capture relevant data on momentary states among individuals with schizophrenia. Cognitive results related to sleep suggest functional applications to digital phenotyping data, and the potential of this multimodal data approach in research.

COVID-19 Vaccine decision-making: trust among the transgender and disability communities in India.

BACKGROUND: Historical marginalisation and ongoing trust deficits in health and government systems shape present-day vaccine perceptions among marginalised communities. This paper sought to understand the role of trust in decision-making about COVID-19 vaccine uptake in the transgender and disability communities in India. METHODS: Using a participatory approach we interviewed 24 community representatives, identifying themselves as transgender individuals or as persons with disability, and 21 key informants such as vaccine programme managers, vaccine providers, and community advocates. We undertook an inductive thematic analysis of the data using a socio-ecological model. RESULTS: Fear of side effects in relation to specific needs of the two communities and mistrust of systems involved in vaccination shaped four different pathways for vaccine decision-making. Mistrust of systems was influenced by past negative experiences with the health system, creating contexts in which information and misinformation are shared and interpreted. Participants negotiated their doubts about safety and mistrust of systems by interacting with different sources of influence showing patterns of decision-making that are dynamic, context-dependent, and intersectional. CONCLUSION: These findings will help in determining the content, strategies and approaches to equitable vaccine communication for these two communities. The two communities ought to be included in vaccine trials. Vaccine information must respond to the specific needs of these two communities which could be enabled by collaboration and engagement with community members and influencers. Finally, long-term investment towards the needs of marginalised communities is vital to dismantle cycles of marginalisation and distrust and in turn improve vaccine acceptance and uptake.

Scaling up the task-sharing of psychological therapies: A formative study of the PEERS smartphone application for supervision and quality assurance in rural India.

Measurement-based peer supervision is one strategy to assure the quality of psychological treatments delivered by non-mental health specialist providers. In this formative study, we aimed to 1) describe the development and 2) examine the acceptability and feasibility of PEERS (Promoting Effective mental healthcare through peER Supervision)-a novel smartphone app that aims to facilitate registering and scheduling patients, collecting patient outcomes, rating therapy quality and assessing supervision quality-among frontline treatment providers delivering behavioral activation treatment for depression. The PEERS prototype was developed and tested in 2021, and version 1 was launched in 2022. To date, 215 treatment providers (98% female; ages 30-35) in Madhya Pradesh and Goa, India, have been trained to use PEERS and 65.58% have completed the supplemental, virtual PEERS course. Focus group discussions with 98 providers were examined according to four themes-training and education, app effectiveness, user experience and adherence and data privacy and safety. This yielded commonly endorsed facilitators (e.g., collaborative learning through group supervision, the convenience of consolidated patient data), barriers (e.g., difficulties with new technologies) and suggested changes (e.g., esthetic improvements, suicide risk assessment prompt). The PEERS app has the potential to scale measurement-based peer supervision to facilitate quality assurance of psychological treatments across contexts.

Experiences of transgender persons in accessing routine healthcare services in India: Findings from a participatory qualitative study.

Despite having a higher burden of health problems, transgender persons face challenges in accessing healthcare in India. Most studies on healthcare access of transgender persons in India focus only on HIV related care, mental healthcare, gender affirmative services or on the ethno-cultural communities or transgender women. This study fills this gap by focusing on diverse gender identities within the transgender community with a specific focus on experiences in accessing general or routine healthcare services. A qualitative descriptive approach was used in this study. 23 in-depth interviews and 6 focus group discussions were conducted virtually and in-person with a total of 63 transgender persons in different regions of India between May and September 2021. The study used a community-based participatory research approach and was informed by the intersectionality approach. Thematic analysis was conducted to analyze the data. Four key themes emerged: (i) intersectional challenges in accessing healthcare start outside of the health system, continue through cisgender-binary-normative health systems that exclude transgender persons; and at the interface with individuals such as health professionals, support staff and bystanders; (ii) the experiences negatively impact transgender persons at an individual level; (iii) in response, transgender persons navigate these challenges across each of the levels: individual, health system level and from outside of the health system. This is a first of its kind qualitative participatory study focusing on routine healthcare services of transgender persons in India. The findings indicate the need to move conversations on trans-inclusion in healthcare from HIV and gender affirmative services to routine comprehensive healthcare services considering the higher burden of health problems in the community and the impact of poor access on their lives and well-being.

ESSENCE: An Implementation Research Program to Scale Up Depression Care in Rural Communities.

BACKGROUND: Task sharing may involve training nonspecialist health workers (NSHWs) to deliver brief mental health interventions. This approach is promising for reducing the global mental health treatment gap. However, capacity is limited for training large cadres of frontline workers in low- and middle-income countries, hindering uptake of these interventions at scale. METHODS: The ESSENCE (enabling translation of science to service to enhance depression care) project in Madhya Pradesh, India, aims to address these challenges through two sequential randomized controlled trials. First, a training trial will evaluate the effectiveness and cost-effectiveness of digital training, compared with conventional face-to-face training, in achieving clinical competency of NSHWs in delivering an intervention for depression. This initial trial will be followed by an implementation trial aimed at evaluating the effectiveness of a remote enhanced implementation support, compared with routine implementation support, in addressing barriers to delivery of depression care in primary care facilities. RESULTS: This project involved developing and pilot testing a scalable smartphone-based program for training NSHWs to deliver a brief psychological intervention for depression screening. This initial research guided a randomized trial of a digital training approach with NSHWs to evaluate the effectiveness of this approach. This trial will be followed by a cluster-randomized trial to evaluate the effectiveness of remote implementation support in ensuring efficient delivery of depression care in primary care facilities. NEXT STEPS: Findings from these trials may inform sustainable training and implementation support models to integrate depression care into primary care for scale-up in resource-constrained settings.

"We are everyone's ASHAs but who's there for us?" a qualitative exploration of perceptions of work stress and coping among rural frontline workers in Madhya Pradesh, India.

OBJECTIVE: More than a million female village-level lay providers called 'Accredited Social Health Activists (ASHAs)', who deliver primary care, face high levels of stress due to work demands and low compensation, within the context of poverty and gender inequality. Evidence on ASHAs has focused on workplace challenges from a system perspective, without sufficient probing into individual-level stress. This study aims to gain perspectives into the experiences of work stress, the related health symptoms, and the responses to stress among ASHAs in India. METHODS: Focus group discussions (FGDs) conducted with ASHAs in Sehore district, Madhya Pradesh, were audio-recorded and transcribed. Grounded theory was used to generate themes under the various domains of ASHAs' work and domestic life. We identified pathways between the conditions that trigger stressful events, experiences of these events, resulting perceptions, effects on health and wellbeing, and approaches used by ASHAs to respond to stress. RESULTS: Six FGDs with 59 ASHAs generated the following themes: (a) Facility: Workload, undue pressures, unstructured work; ASHAs' relationships with seniors (e.g., feelings of being disrespected, blamed, or targeted), and low access to physical and administrative resources; (b) Home: Feelings of guilt for putting less time for family/child care; disrespect by the elderly for a poorly incentivised job; (c) Community: Low acceptance by the villagers; caste- and gender-bias; difficult community-level relationships (emotional labour, fear/stigma towards her services); (d) Somatic and psychological symptoms: headache, exhaustion, depressive symptoms (to cite a few); and (e) Responses to stress: Motivation (support from peers, family, a sense of identity/pride, incentives), Individual strengths (e.g., social responsibility), and spiritual recourse mechanisms. CONCLUSIONS: This study will inform the development of a strengths-based coaching intervention to address work stress among ASHAs. The findings are relevant to building the evidence on alleviation of work stress among female frontline cadres in low-resource settings globally.

Impact of the COVID-19 pandemic on the mental health of transgender persons in India: Findings from an exploratory qualitative study.

Introduction: Transgender persons in India, who are one of the most vulnerable groups, were particularly impacted by the COVID-19 pandemic. Increased risk of COVID-19, challenges with continuing livelihood, uncertainty, and anxiety around the pandemic over pre-existing social discrimination and exclusion pose risk of a mental health impact as well. To investigate this further, this component of a larger study on experiences in healthcare of transgender persons in India during COVID-19 and looks into the question "How did the COVID-19 pandemic impact the mental health of transgender persons in India". Methods: 22 In-depth interviews (IDI) and 6 focus group discussions (FGD) were conducted virtually and in-person with persons self-identifying as transgender or belonging to ethnocultural transgender communities from different parts of India. Community based participatory research approach was used by ensuring representation from the community in the research team and through a series of consultative workshops. Purposive sampling with snowballing was used. The IDIs and FGDs were recorded, transcribed verbatim and analyzed using an inductive thematic analysis. Results: Mental health of transgender persons were affected in the following ways. Firstly, COVID-19, its associated fear and suffering combined with pre-existing inaccessibility of healthcare and reduced access to mental health care affected their mental health. Secondly, unique social support needs of transgender persons were disrupted by pandemic linked restrictions. Thirdly, pre-existing vulnerabilities such as precarious employment and underlying stigma were exacerbated. Finally, gender dysphoria was a key mediating factor in the impact of COVID-19 on mental health with a negative and positive impact. Conclusions: The study reiterates the need to make systemic changes to make mental healthcare and general healthcare services trans-inclusive while also recognizing the essential nature of gender affirmative services and the need to continue them even during emergencies and disaster situations. While this brings out how public health emergencies can exacerbate vulnerabilities, it also shows how the lived mental health experience of transgender person is intricately linked to the way work, travel and housing is structured in our society and therefore points to the structural nature of the linkage between mental health and gender.

Development of a Digital Program for Training Community Health Workers in the Detection and Referral of Schizophrenia in Rural India.

This study aimed to develop and assess the acceptability of a digital program for training community health workers (CHWs) in the detection and referral of patients with schizophrenia in community settings in rural India. An iterative design process was employed. First, evidence-based content from existing community programs for schizophrenia care was incorporated into the curriculum, and reviewed by experts to ensure clinical utility and fidelity of the adapted content. Second, CHWs provided feedback on the appropriateness of language, content, and an initial prototype of the digital training program to ensure relevance for the local context. Focus group discussions were then used to understand the acceptability of the digital training prototype and to inform modifications to the design and layout. Qualitative data was analysed using a rapid thematic analysis approach based on predetermined topics pertaining to acceptability of the training content and digital platform. Development of the initial prototype involved content review by 13 subject matter experts with clinical expertise or experience accessing and receiving mental health services, and engagement of 23 CHWs, of which 11 provided feedback for contextualization of the training content and 12 participated in focus group discussions on the acceptability of the prototype. Additionally, 2 service-users with lived experience of schizophrenia contributed to initial testing of the digital training prototype and offered feedback in a focus group discussion. During contextualization of the training content, key feedback pertained to simplifying the language and presentation of the content by removing technical terms and including interactive content and images to enhance interest and engagement with the digital training. During prototype testing, CHWs shared their familiarity with similar symptoms but were unaware of schizophrenia as a treatable illness. They shared that training can help them identify symptoms of schizophrenia and connect patients with specialized care. They were also able to understand misconceptions and discrimination towards people with schizophrenia, and how to address these challenges by supporting others and spreading awareness in their communities. Participants also appreciated the digital training, as it could save them time and could be incorporated within their routine work. This study shows the acceptability of leveraging digital technology for building capacity of CHWs to support early detection and referral of schizophrenia in community settings in rural India. These findings can inform the subsequent evaluation of this digital training program to determine its impact on enhancing the knowledge and skills of CHWs.

Relapse prediction in schizophrenia with smartphone digital phenotyping during COVID-19: a prospective, three-site, two-country, longitudinal study.

Smartphone technology provides us with a more convenient and less intrusive method of detecting changes in behavior and symptoms that typically precede schizophrenia relapse. To take advantage of the aforementioned, this study examines the feasibility of predicting schizophrenia relapse by identifying statistically significant anomalies in patient data gathered through mindLAMP, an open-source smartphone app. Participants, recruited in Boston, MA in the United States, and Bangalore and Bhopal in India, were invited to use mindLAMP for up to a year. The passive data (geolocation, accelerometer, and screen state), active data (surveys), and data quality metrics collected by the app were then retroactively fed into a relapse prediction model that utilizes anomaly detection. Overall, anomalies were 2.12 times more frequent in the month preceding a relapse and 2.78 times more frequent in the month preceding and following a relapse compared to intervals without relapses. The anomaly detection model incorporating passive data proved a better predictor of relapse than a naive model utilizing only survey data. These results demonstrate that relapse prediction models utilizing patient data gathered by a smartphone app can warn the clinician and patient of a potential schizophrenia relapse.

Stress Alleviation Methods for community-Based Health ActiVists (SAMBHAV): Development of a digital program for stress reduction for community health workers in rural India.

Background: Community health workers (CHWs) face high levels of stress (both professional and personal) and risk of burnout, highlighting the need for efforts to promote their mental health and well-being. This study seeks to develop a digital stress reduction program for CHWs in rural India. Methods: A stepwise design process was employed to adapt and digitize the evidence-based World Health Organization's Self-Help Plus (SH+) intervention for addressing psychological distress among CHWs in Madhya Pradesh, India. This involved participatory design workshops with CHWs to ensure that the digital stress reduction intervention would be relevant for their needs and the local culture and context. Small groups of CHWs reviewed the adapted program content, allowing the research team to make refinements such as simplifying language, tailoring content to the local setting, and ensuring that program materials are both interesting and relevant. Simultaneously, the research team digitized the content, leveraging a combination of video and graphical content, and uploaded it to the Sangath Learning Management System, a digital platform accessible on a smartphone app. Results: In total, 18 CHWs contributed to the adaptation of the SH+ content and digital intervention development. Participants commented on finding some terms difficult to follow and recommended simplifying the language and providing detailed explanations. Participants offered positive feedback on the adapted content, expressing that they found the examples covered in the material both relatable and relevant to their own personal experiences at home and in the workplace. By combining participants' insights and comments with feedback from content experts, it was possible to finalize a digital Hindi version of the SH+ intervention for CHWs in rural India. Conclusions: This study is timely given the continued detrimental impacts of the COVID-19 pandemic, and offers a promising and potentially scalable digital program to alleviate psychological distress among frontline health workers.

Smartphone digital phenotyping, surveys, and cognitive assessments for global mental health: Initial data and clinical correlations from an international first episode psychosis study.

Objective: To examine feasibility and acceptability of smartphone mental health app use for symptom, cognitive, and digital phenotyping monitoring among people with schizophrenia in India and the United States. Methods: Participants in Boston, USA and Bhopal and Bangalore, India used a smartphone app to monitor symptoms, play cognitive games, access relaxation and psychoeducation resources and for one month, with an initial clinical and cognitive assessment and a one-month follow-up clinical assessment. Engagement with the app was compared between study sites, by clinical symptom severity and by cognitive functioning. Digital phenotyping data collection was also compared between three sites. Results: By Kruskal-Wallis rank-sum test, we found no difference between app activities completed or digital phenotyping data collected across the three study sites. App use also did not correlate to clinical or cognitive assessment scores. When using the app for symptom monitoring, preliminary findings suggest app-based assessment correlate with standard cognitive and clinical assessments. Conclusions: Smartphone app for symptom monitoring and digital phenotyping for individuals with schizophrenia appears feasible and acceptable in a global context. Clinical utility of this app for real-time assessments is promising, but further research is necessary to determine the long-term efficacy and generalizability for serious mental illness.

Schizophrenia Assessment, Referral and Awareness Training for Health Auxiliaries (SARATHA): Protocol for a Mixed-Methods Pilot Study in Rural India.

BACKGROUND: Workforce shortages pose major obstacles to the timely detection and treatment of schizophrenia, particularly in low-income and middle-income countries. The SARATHA (Schizophrenia Assessment, Referral, and Awareness Training for Health Auxiliaries) project involves the systematic development, iterative refinement, and pilot testing of a digital program for training community health workers in the early detection and referral of schizophrenia in primary care settings in rural India. METHODS: SARATHA is a three-phase study. Phase 1 involves consulting with experts and clinicians, and drawing from existing evidence to inform the development of a curriculum for training community health workers. Phase 2 consists of designing and digitizing the training content for delivery on a smartphone app. Design workshops and focus group discussions will be conducted to seek input from community health workers and service users living with schizophrenia to guide revisions and refinements to the program content. Lastly, Phase 3 entails piloting the training program with a target sample of 20 community health workers to assess feasibility and acceptability. Preliminary effectiveness will be explored, as measured by community health workers' changes in knowledge about schizophrenia and the program content after completing the training. DISCUSSION: If successful, this digital training program will offer a potentially scalable approach for building capacity of frontline community health workers towards reducing delays in early detection of schizophrenia in primary care settings in rural India. This study can inform efforts to improve treatment outcomes for persons living with schizophrenia in low-resource settings.

Assessing costs of developing a digital program for training community health workers to deliver treatment for depression: A case study in rural India.

Digital technology has emerged as a promising approach for training and building capacity of community health workers in low-income and middle-income countries (LMICs). Little is known about the cost of developing digital training programs in LMICs, which hinders the adoption, implementation, and scaling up of the programs in routine primary care settings. This study assessed the costs of developing a digital program for training community health workers to deliver a psychological treatment for depression in a rural district of Madhya Pradesh, India. We developed survey instruments to document required resources in development, including involved personnel (their roles, responsibilities, time spent, and salaries or payments), information technologies (e.g., smartphones, software programs), and infrastructure-related costs (e.g., vehicle, office space, utilities). Costs were estimated from an accounting perspective. Over a 10-month developmental period, the total costs were 208,814 USD, with the largest portion on human resources (61%, with 14% on management and supervision), followed by information technologies (33%), and infrastructure-related costs (6%). These findings could inform policymakers in LMICs on costs of developing online-training programs, which will be especially useful during the COVID-19 pandemic.

A qualitative exploration of perceived needs and barriers of individuals with schizophrenia, caregivers and clinicians in using mental health applications in Madhya Pradesh, India.

Introduction: About 3.5 million people are living with schizophrenia in India, with most failing to receive minimally adequate care. Digital mental health applications could potentially decrease this treatment gap; however, these applications should be tailored to meet the needs and overcoming barriers of its end-users to ensure their adoption and sustained usage. Few studies in India have explored the perspectives of target stakeholders to understand how digital tools could be viable for supporting care. Therefore, this study explores the perceived needs and barriers of patients with schizophrenia, caregivers and clinicians in using digital mental health applications. Methods: Focus group discussions (FGDs) were conducted with patients having schizophrenia attending outpatient clinics at a government tertiary hospital, and their caregivers, and mental health clinicians in Bhopal, Madhya Pradesh, India. FGDs were audio-recorded and coded. Framework analysis was employed to guide the analysis, involving deductive and inductive generation of themes, data triangulation and comparison of perspectives between participant groups. Results: Six FGDs were conducted with individuals with schizophrenia (n â€‹= â€‹11), their caregivers (n â€‹= â€‹14), and mental health clinicians (n â€‹= â€‹19). Four a priori themes were established: a) Prior experiences with health applications; b) Content of a mental health application; c) Involvement of caregivers in mental health application usage and d) Supporting doctors' work through mental health applications. Additionally, two themes were generated inductively: a) Qualities of a mental health application and b) Data privacy and confidentiality. Conclusion: Exploration of stakeholder perspectives on the content, features, and uses of mental health applications is crucial to yield initial insights about the use of these digital programs in India. This study generated a multitude of suggestions on app functionality and components, which can guide ongoing efforts to develop and deliver digital mental health applications for patients living with schizophrenia in low-resource settings, with limited access to mental health services.

Cross cultural and global uses of a digital mental health app: results of focus groups with clinicians, patients and family members in India and the United States.

BACKGROUND: Despite significant advancements in healthcare technology, digital health solutions - especially those for serious mental illnesses - continue to fall short of their potential across both clinical practice and efficacy. The utility and impact of medicine, including digital medicine, hinges on relationships, trust, and engagement, particularly in the field of mental health. This paper details results from Phase 1 of a two-part study that seeks to engage people with schizophrenia, their family members, and clinicians in co-designing a digital mental health platform for use across different cultures and contexts in the United States and India. METHODS: Each site interviewed a mix of clinicians, patients, and their family members in focus groups (n = 20) of two to six participants. Open-ended questions and discussions inquired about their own smartphone use and, after a demonstration of the mindLAMP platform, specific feedback on the app's utility, design, and functionality. RESULTS: Our results based on thematic analysis indicate three common themes: increased use and interest in technology during coronavirus disease 2019 (COVID-19), concerns over how data are used and shared, and a desire for concurrent human interaction to support app engagement. CONCLUSION: People with schizophrenia, their family members, and clinicians are open to integrating technology into treatment to better understand their condition and help inform treatment. However, app engagement is dependent on technology that is complementary - not substitutive - of therapeutic care from a clinician.

Development and implementation of COVID-19 safety protocols for conducting a randomized trial in global mental health: Field report from Central India.

The COVID-19 pandemic impacted ongoing clinical trials globally resulting in the suspension, cancellation or transition to entirely remote implementation of studies. In India, the first countrywide lockdown was imposed in phases starting from March 2020 to June 2020, followed by a continued restriction on in-person activities including study procedures, which halted the ESSENCE (Enabling translation of Science to Service to ENhance Depression CarE) trial activities such as recruitment, consenting, baseline assessment, digital training orientation, face to face training and end-line assessment evaluation. This situation made it imperative to amend procedures in order to mitigate the risk and address safety requirements for participants and the research team. This paper summarizes the need, development and implementation of the protocols focused on risk reduction and safety enhancement with an objective to resume and continue the research activities while ensuring the safety of study participants and research staff. These protocols are comprised of guidelines and recommendations based on existing literature tailored according to different components in each arm of the trial such as guidelines for supervisors, travellers, training/recruitment venue safety procedures, individual safety procedures; and procedures to implement the study activities. These protocols can be adapted by researchers in other settings to conduct research trials during pandemics such as COVID-19.

Identifying challenges and recommendations for advancing global mental health implementation research: A key informant study of the National Institute of Mental Health Scale-Up Hubs.

OBJECTIVE: This study explored perspectives of researchers working with the National Institute of Mental Health (NIMH) Scale-Up Hubs, consisting of research partnerships for scaling up mental health interventions in low- and middle-income countries (LMICs), to: 1) identify common barriers to conducting impactful research on the implementation of evidence-based mental health services; and 2) provide recommendations to overcome these implementation challenges. METHODS: A sequential qualitative approach was employed. First, an open-ended survey was distributed to the 10 Scale-Up Hubs and NIMH program staff asking informants to identify challenges in conducting mental health implementation research in LMICs. Second, survey findings guided an in-person workshop to generate implementation recommendations to inform the field. RESULTS: In total, 46 respondents completed surveys, and 101 researchers attended the workshop. The workshop produced implementation recommendations for low-resource settings: 1) identifying impact of research on policy and practice; 2) sustaining careers of early researchers in global mental health; 3) engaging policymakers and donors to value mental health research; 4) supporting the workforce for delivering evidence-based treatments for mental disorders; and 5) promoting sustainability of programs. CONCLUSIONS: These findings can strengthen collaboration between researchers and key stakeholders, and highlight important targets for improving mental health implementation research in LMICs.