A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol.

BACKGROUND: The elderly population has been growing in most low- and middle-income countries (LMIC), and depression is a common condition among these populations. The lack of integration between mental health and primary healthcare services and the shortage of mental health specialists in the public health system contribute to underdiagnosis and undertreatment of depression. One of the strategies to reduce this gap is task shifting and collaborative care treatments. This study therefore aims to evaluate the effectiveness and cost-effectiveness of a collaborative care psychosocial intervention to improve the clinical management of depression among elderly people in poor neighbourhoods in Guarulhos, Brazil. METHODS: Two-arm, cluster randomised controlled trial with Basic Health Units as the clusters and a 1:1 allocation ratio. Twenty Basic Health Units have been randomly selected and randomised to control or intervention arms. We aim to recruit 1440 adults (72 per cluster) aged 60 years or over identified with depression (9-item Patient Health Questionnaire (PHQ-9) score ≥ 10). The control arm participants will receive an enhanced usual care, while the intervention arm participants will receive an enhanced usual care and a 17-week psychosocial intervention programme delivered at home by community health workers with the help of an application installed on tablet computers. The primary outcome is the proportion with depression recovery (PHQ-9 < 10) at 8 months' follow-up. We will also assess the maintenance of any earlier clinical gains and the cost-effectiveness of the intervention at 12 months. DISCUSSION: This is the first randomised trial to investigate a collaborative care intervention to treat depression among poor elderly in LMIC/Latin America. This is a major public health problem worldwide, but in these countries, there are no locally tested, evidence-based interventions available to date. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN57805470 . Registered on 25 April 2019.

Investigating Software Requirements for Systems Supporting Task-Shifted Interventions: Usability Study.

BACKGROUND: There is a considerable shortfall in specialized health care professionals worldwide to deliver health services, and this shortfall is especially pronounced in low-middle-income countries. This has led to the implementation of task-shifted interventions, in which specific tasks are moved away from highly qualified health workers to health workers with less training. The World Health Organization (WHO) has published recommendations for such interventions, but guidelines for software and systems supporting such interventions are not included. OBJECTIVE: The objective of this study was to formulate a number of software requirements for computer systems supporting task-shifted interventions. As the treatment of mental health problems is generally considered to be a task for highly trained health care professionals, it poses interesting case studies for task-shifted interventions. Therefore, we illustrated the use of the identified software requirements in a mobile system created for a task-shifted depression intervention to be provided to older adults in deprived areas of São Paulo, Brazil. METHODS: Using a set of recommendations based on the WHO's guidance documentation for task-shifted interventions, we identified 9 software requirements that aim to support health workers in management and supervision, training, good relationship with other health workers, and community embeddedness of the intervention. These 9 software requirements were used to implement a system for the provision of a psychosocial depression intervention with mobile Android interfaces to structure interventions and collect data, and Web interfaces for supervision and support of the health care workers delivering the intervention. The system was tested in a 2-arm pilot study with 33 patients and 11 health workers. In all, 8 of these 11 health workers participated in a usability study subsequent to the pilot. RESULTS: The qualitative and quantitative feedback obtained with the System Usability Scale suggest that the system was deemed to have a usability of between OK and Good. Nevertheless, some participants' responses indicated that they felt they needed technical assistance to use the system. This was reinforced by answers obtained with perceived usefulness and ease of use questionnaires, which indicated some users felt that they had issues around correct use of the system and perceived ability to become skillful at using the system. CONCLUSIONS: Overall, these high-level requirements adequately captured the functionality required to enable the health workers to provide the intervention successfully. Nevertheless, the analysis of results indicated that some improvements were required for the system to be useable in a task-shifted intervention. The most important of these were better access to a training environment, access for supervisors to metadata such as duration of sessions or exercises to identify issues, and a more robust and human-error-proof approach to the availability of patient data on the mobile devices used during the intervention.

Pilot study of a two-arm non-randomized controlled cluster trial of a psychosocial intervention to improve late life depression in socioeconomically deprived areas of São Paulo, Brazil (PROACTIVE): feasibility study of a psychosocial intervention for late life depression in São Paulo.

BACKGROUND: Depression is a common and recurrent condition among older adults and is associated with poor quality of life and increased health care utilization and costs. The purpose of this pilot study was to assess the feasibility of delivering a psychosocial intervention targeting depression, and to develop the procedures to conduct a cluster randomized controlled trial among older adults registered with primary care clinics in poor neighbourhoods of São Paulo, Brazil. METHODS: We conducted a pilot study of a two-arm cluster, non-randomized controlled trial. Two primary care clinics adhering to the Family Health Strategy were allocated to either the intervention or the control arm. In the control arm, patients received enhanced usual care consisting of staff training for improved recognition and management of depression. In the intervention arm, alongside the enhanced usual care, patients received a 17-week psychosocial intervention delivered by health workers assisted with an application installed in a tablet. RESULTS: We randomly selected 579 of 2020 older adults registered in the intervention clinic to participate in the study. Among these individuals, 353 were assessed for depression and 40 (11.0%) scored at least 10 on the PHQ-9 and were therefore invited to participate. The consent rate was 33/40 (82%) with a resulting yield of 33/579 (5.7%). In the control arm, we randomly selected 320 older adults among 1482 registered in the clinic, 223 were assessed for depression and 28 (12.6%) scored 10 or above on the PHQ-9. The consent rate was 25/28 (89%), with a resulting yield of 25/320 (7.8%). Of the 33 who consented in the intervention arm, 19 (59.4%) completed all sessions. The mean PHQ-9 at follow-up (approximately 30 weeks after inclusion) were 12.3 (SD = 3.7) and 3.8 (SD = 3.9) in the control and intervention arms, respectively. Follow-up rates were 92 and 94% in control and intervention arms, respectively. CONCLUSIONS: Identification and engagement of clinics, randomization, recruitment of individuals, measures, and baseline and follow-up assessments all proved to be feasible in primary care clinics in São Paulo, Brazil. Results support the development of a definitive cluster randomized controlled trial. TRIAL REGISTRATION: This study was retrospectively registered with Registro Brasileiro de Ensaios Clínicos (ReBEC), number RBR-5nf6wd . Registered 06 August 2018.