Overview
During the last year we developed a low-intensity psycho-educational intervention delivered via a smartphone application for depressed people treated in general medical settings for their chronic disease. CONEMO is a 6-week intervention designed to reduce symptoms of depression. This application for smartphones will deliver messages related to depression and behavior activation three times per week. Nurse Assistants (NA) support will be provided to enhance adherence to behavioral activation activities. The NA is responsible for monitoring CONEMO app use and the participants performance via a web interface, providing information about using the app and technical support. The NA is also responsible for communicating the progress of the patient in the study to the supervisor and, if necessary, to the doctor/nurse responsible for the participant. Participants will be aware that their activity and progress are monitored by the nurse through a nurse web interface in the CONEMO system. During the pilot study, phone calls will be made by the NA congratulating adherence and offering suggestions during non-adherence.
We proposed three phases to develop the study:
Phase 1: Formative Research: To develop, design, and pilot test a psycho-educational intervention (CONEMO) delivered mostly via mobile smartphones and exploring barriers and facilitators to its implementation, as well as refining methodological aspects in preparation for the clinical trials.
Phase 2: Effectiveness Research: A cluster randomized effectiveness trial comparing usual care plus CONEMO to usual care alone, evaluating effects of the CONEMO program on clinical outcomes, health-related quality of life, and patients’ satisfaction with care and treatment costs.
Phase 3: Dissemination/Implementation: Development of effective strategies for disseminating CONEMO in Latin America and elsewhere.
Activities developed during the first year
In the first quarter, corresponding to the months of October, November and December 2013, the main objective related to the research aspect of the project was to assess the usability of smartphones by the target population. Usability tests were performed in two primary healthcare units in São Paulo (UBS Vila Dalva - Western region of São Paulo, and UBS Vila Espanhola – Northern region of São Paulo), with 20 patients. The three researchers (SA, PV, RN) who conducted the interviews, worked together in the discussion, translation and adaptation of the questionnaire, and also in the app handling.
In the next quarter, which referred to the period from January 1st. to March 31st. 2014, efforts were directed towards achieving the final written version of the CONEMO app both in Spanish and Portuguese, and developed the Nurse Assistant Support System. The tasks of the research protocol and procedures for the Pilot Study were also defined.
The third quarter referred to Phase 3 of the Formative Research, which included the 3-month period between April 1st and June 30th 2014. We conducted further usability tests with two volunteers in São Paulo, which generated relevant information during the visit of the NW team and a better understanding of the complexity of the CONEMO system by USP and UPCH teams. This also culminated with better quality in drafting documents and other materials related to the study.
In the Phase 4 of the Formative Research, including the 3-month period from July 1st to September 25th. During this phase, the tasks of the different professionals involved in the pilot test were defined as well as the strategy for recruiting candidates for the study pilot. The Nurse Assistant Manual and the Participant’s Guide were concluded in the 3 languages (English, Portuguese and Spanish) and a special guide for the use of the smartphone app was elaborated to make sure both nurses and patients would have a quick reference guide. The material for the NA training was prepared.
What have we done so far?
The project already started. Its official launching took place on July 10th, 2013 at the Initial Summit meeting in Sao Paulo. This activity has been funded by Paulo Menezes through a grant from the University of Sao Paulo.
We have made progress in several directions:
- Columbia University’s Department of Psychiatry collaborates with LATIN-MH in the training of the next genera- tion of US scientists who will focus on Global Mental Health implementation research. The NIMH has funded a research fellowship program (T32MH096724) led by and Drs Maria Oquendo and Milton Wainberg seeking to train new U.S. investigators who will focus on devising strategies to close the enormous mental health gap ob- served in LMIC and beyond, using treatments that are evidence based and can make a difference in the lives of those afflicted by mental illness. LATIN-MH has been instrumental in identifying mentors for research fellows from among his many collaborators in Peru and Brazil. Fellows are now actively working in close collaboration with faculty at Universidad Peruana Cayetano Heredia in Lima, Peru, developing approaches to implementation of mental health services in public health community primary care settings. Our first collaborative Fellow (Dr Pamela Scorza) will be working in Peru as part of this collaboration.
- Professor Araya is collaborating in three additional seed projects in Guatemala, Colombia, and Peru funded by Canada Grand Mental Health Challenges. These new projects seek to strengthen a similar line of research.
- A scientific conference was delivered by the Senior Faculty of our hub attending the initial Summit.
- We conducted lectures at NorthWestern University, University of Sao Paulo, and we participated in a joint conference in Santiago, Chile, in collaboration with RedesAmericas in September 2013.
- We named a research project coordinator, Julieta Quayle, a clinical psychologist with a doctorate in this field. Also we have appointed a capacity building coordinator, Barbara Bonini, who is a registered nurse with a PhD..
- The Executive Committee of the Central hub met, and several researchers involved with the research component have held regular weekly meetings via web in order to develop the intervention being tested. Substantial progress was made in developing an application in collaboration with Northwestern University. Mark Beagle and Marya Corden are the two leading experts in this field and are working on this initiative.
- In December 2014 took place another meeting of the Hub, in São Paulo, to prepare the pilot study.
- In the first half of 2015 we conducted pilot studies in Brazil and Peru.
- In June 2015 there was another meeting of the Hub to evaluate the results of the pilot study and organize the start of the RCT. Was held also the Latin America Treatment and Innovation Network in Mental Health Symposium, which presentations are available for download.
- We are currently preparing for starting the trial (RCT) in Brazil and Peru in 2016.
Goals for the next period
For the next period, we are planning to:
1) Contemplate the pilot study activities and its analysis. This pilot study is primarily aimed at testing how patients respond to the CONEMO intervention, as indicated by the severity of their depressive symptoms over time. Secondary aims include exploring barriers and facilitators to the implementation of CONEMO, in order to refine methodological aspects in the preparation of two large clinical trials to estimate the efficacy of the CONEMO intervention;
2) Develop the Supervisor’s Dashboard;
3) Select and train the field research team for the full trial;
4) Select the clinics participating in the full Trial and train the Nurse Assistants participating in the full trial. Develop the DSMP board for the full trial;
5) Start the full trial.
