Barriers and facilitators to implementing a mobile intervention with task shifting in the treatment of depressive symptoms in people with diabetes and / or hypertension in Brazil: A study protocol using the CFIR.

Background: Task-shifting and eHealth have been proposed as ways of approaching the mental health treatment gap in low and middle-income countries (LMIC). The Latin America Treatment & Innovation Network in Mental Health (LATIN-MH) developed CONEMO (Emotional Control), a behavioral intervention used to treat depressive symptoms in a sample of patients with diabetes and hypertension in Sao Paulo, Brazil. The intervention uses task shifting and is delivered via a smartphone app. The effectiveness of this intervention was tested in two randomized trials in these countries. Aim: This paper aims to present the protocol for a study that will explore perceived barriers and facilitators to implementing this intervention to help future scale-up. Methods: We will conduct qualitative research with users of the CONEMO intervention and health professionals who participated directly and indirectly in the trial in Brazil. We will use semi-structured interviews, and we will adopt the Consolidated Framework for Implementation Research (CFIR) for data analysis. Discussion: Task-shifting and eHealth are potentially important tools to help decrease the mental health treatment gap in Latin America. This study will increase our understanding of the factors which may facilitate or hinder the implementation of mobile behavioral mental health interventions, using task-shifting, within LMICs. Findings could be used in future design and planning to facilitate successful implementation and treatment. network of regional hubs for mental health research in Africa, Asia, and Latin America, with capabilities for answering research questions (within and across regions) aimed at improving mental health outcomes for men, women, and children. Each hub supports research on task-shifting/task-sharing for the delivery of mental health services and provides research capacity-building opportunities. Hub teams are interdisciplinary, with strong interests in increasing the capacity of mental health services; enhancing collaborative learning and development; integrating local, state and national health interventions, and building relationships with governmental, non-governmental, and community-based stakeholders.” The five hubs are Africa Focus on Intervention Research for Mental Health - AFFIRM; Latin America Treatment and Innovation Network for Mental Health - LATIN-MH; Partnership for Mental Health Development in Sub-Saharan Africa - PaM-D; Regional Network for Mental Health Research in Latin America -RedeAmerica; South Asian Hub for Advocacy, Research & Education on Mental Health - SHARE.


Authors' contributions
HC and PM conceived the design of the study and drafted the protocol paper. MC contributed to the design of the study. All authors wrote, read, commented, and approved the final manuscript.

Title {1}
Barriers and facilitators to implementing a mobile intervention with task shifting in the treatment of depressive symptoms in people with diabetes and/or hypertension in Brazil: A study protocol using the CFIR.

Background
Mental health problems often coexist with physical health difficulties. Rates of depression in populations with chronic disease are found to be higher than those in the general community. In Brazil, the prevalence rate of depression is 4.1%, rising to 7.5% in those with hypertension and 8.6% in those with diabetes

Method
We will conduct a cross-sectional qualitative study using semi-structured interviews to explore the barriers and facilitators to successful implementation of CONEMO, from a professional and user perspective.

Sample
We will interview individuals who either participated in the RCTs as a participant (patient of the health care system) or as health care professional For this study, the user's sample constitution criteria will be nonprobabilistic, using the saturation theory to determine the final sample (Mason, 2010). This will enable us to reach a representative sample, with a diverse range of experience with the RCT process.

Interviews Guide
The semi-structured interviews will be based on a standard proposal from the "Collaborative HUBs Shared Research" to facilitate the comparison of data across HUBs. The proposal has been translated and culturally adapted by the Latin-MH research team.
There will be four interview templates, one for each participant category: participants from intervention, NAs, Managers, and policymakers. A summary of the RCT proposal will be presented to policymakers before the interview since they did not participate in the RCT.

Participant selection
The following criteria will be used for selecting participants, respecting the proportion in each category: a) Adherence to intervention: i) No adherence: participants who completed only the training session; ii) Medium adherence: participants who completed up to 50% of sessions; iii) High adherence: participants who completed more than 50% of sessions.

b) Geographic area: participants from all FHU's in Sao Paulo
The list of relevant characteristics and the number of participants required will be sent to the Data Center Coordination (DCC). The DCC will then provide a list of potential participants. We will use the software Stata 13 to carry out a selection by drawing, respecting the established criteria. The health professionals will be selected based on the experience of the research team based on their engagement.

Data Collection
Participants will be contacted by phone, and those interested in taking part will be interviewed by the research team, who will give a detailed explanation about the research, allowing questions, and obtaining informed consent.
Interviews will be face-to-face, recorded using a portable voice recorder, and subsequently transcribed verbatim. Interviews will take place confidentially, in a private room, free from noise and distraction.

Data Analysis
After transcription, interviews will be analyzed using QSR International Pty Ltd's N-VIVO 12 Pro For Windows, software to support the organization and analysis of qualitative interview data.
The Consolidated Implementation Research Framework (CFIR) will be used to guide the analysis to understand the facilitators and barriers to implementation. The CFIR is a conceptual explanatory framework used to identify constructs and mechanisms which may influence implementation and effectiveness (Damschroder et al. 2009).

Discussion
Task-shifting and e-health are viable strategies for increasing access to mental health care and reducing the treatment gap. CONEMO is one such intervention, and if shown to be effective, it would be fundamental to investigate which aspects can facilitate or hinder its implementation. This study is fundamental to help identify and understand the facilitators and barriers to implementation of the CONEMO intervention from the perspective of those involved. Analyzing the social, cultural and territorial representations related to this intervention will allow the design of a customized proposal, with higher chances of being accepted and, therefore, successful.

Trial Status
Recruitment closed.