'Does it matter how old I feel?' The role of subjective age in a psychosocial intervention for improving depressive symptomatology among older adults in Brazil (PROACTIVE).

OBJECTIVES: Depression is a prevalent mental health condition that also often affects older adults. The PROACTIVE psychosocial intervention was developed to reduce depressive symptomatology among older adults within primary care settings in Brazil. An important psychological marker that affects individuals' aging experience relates to how old people feel. Known as subjective age, this marker has been shown to be a risk factor for experiencing greater depressive symptoms if individuals report feeling older than their (chronological) age. In this study, we perform secondary analyses of the PROACTIVE cluster-randomized controlled trial to examine the role of subjective age. METHOD: The sample included 715 Brazilian older adults (74% female, Mage 68.6, SD = 6.9, age range: 60-94 years) randomized to intervention (n = 360, 74% female, Mage 68.4, SD = 6.6, age range: 60-89 years) or control (n = 355, 74% female, Mage 68.9, SD = 7.2, age range: 60-94 years) arms. Here our primary outcome was depressive symptoms at the 8-month follow-up assessed with the 9-item Patient Health Questionnaire (PHQ-9) as a continuous variable. Our previous analyses demonstrated improved recovery from depression at follow-up in the intervention compared with the control arm. RESULTS: Relevant main effects and interactions in regression models for PHQ-9 presented here found that those reporting older subjective age had worse depressive symptoms at follow-up but that they benefitted more from the intervention when initial levels of depression were high. For participants who reported younger subjective ages the intervention showed positive effects that were independent of initial levels of depression. CONCLUSION: Our findings emphasize the importance of investigating possible underlying mechanisms that can help clarify the impact of mental health interventions.

Self-help mobile messaging intervention for depression among older adults in resource-limited settings: a randomized controlled trial.

Scalable solutions to treat depression in older adults in low-resourced settings are urgently needed. The PRODIGITAL-D pragmatic, single-blind, two-arm, individually randomized controlled trial assessed the effectiveness of a mobile messaging psychosocial intervention in improving depressive symptomatology among older adults in socioeconomically deprived areas of Guarulhos, Brazil. Older adults (aged 60+ years) registered with 24 primary care clinics and identified with depressive symptomatology (9-item Patient Health Questionnaire (PHQ-9) scores ≥ 10) received the 6-week Viva Vida intervention based on psychoeducation and behavioral activation (n = 298) or a single message (n = 305). No health professional support was offered. The primary outcome was improvement from depressive symptomatology (PHQ-9 < 10) at 3 months. Of the 603 participants enrolled (mean age = 65.1 years; 451 (74.8%) women), 527 (87.4%) completed the follow-up assessment. In the intervention arm, 109 of 257 (42.4%) participants had an improved depressive symptomatology, compared with 87 of 270 (32.2%) participants in the control arm (adjusted odds ratio = 1.57; 95% confidence interval = 1.07-2.29; P = 0.019). No severe adverse events related to trial participation were observed. These results demonstrate the usefulness of a digital messaging psychosocial intervention in the short-term improvement from depressive symptomatology that can potentially be integrated into primary care programs for treating older adults with depression. Brazilian Registry of Clinical Trials registration: ReBEC ( RBR-4c94dtn ).

A task-shared, collaborative care psychosocial intervention for improving depressive symptomatology among older adults in a socioeconomically deprived area of Brazil (PROACTIVE): a pragmatic, two-arm, parallel-group, cluster-randomised controlled trial.

BACKGROUND: There is an urgent need to reduce the burden of depression among older adults in low-income and middle-income countries (LMICs). We aimed to evaluate the efficacy of a task-shared, collaborative care psychosocial intervention for improving recovery from depression in older adults in Brazil. METHODS: PROACTIVE was a pragmatic, two-arm, parallel-group, cluster-randomised controlled trial conducted in Guarulhos, Brazil. Primary care clinics (clusters) were stratified by educational level and randomly allocated (1:1) to either enhanced usual care alone (control group) or to enhanced usual care plus the psychosocial intervention (intervention group), which involved a 17-week psychosocial programme based on psychoeducation and behavioural activation approaches. Individuals approached for the initial screening assessment were selected randomly from a list of individuals provided by the Health Secretariat of Guarulhos. Face-to-face baseline assessments were conducted among adults aged 60 years or older registered with one of the primary care clinics and identified with clinically significant depressive symptomatology (9-item Patient Health Questionnaire [PHQ-9] score ≥10). Community health workers delivered the programme through home sessions, supported by a dedicated tablet application. Masking of clinic staff and community health workers who delivered the intervention was not feasible; however, research assistants conducting recruitment and follow-up assessments were masked to trial allocation. The primary outcome was recovery from depression (PHQ-9 score <10) at 8-month follow-up. All primary analyses were performed by intention to treat with imputed data. Adaptations to the protocol were made due to the COVID-19 pandemic; recruitment and intervention home sessions were stopped, and follow-up assessments were conducted by telephone. This trial is registered with the ISRCTN registry, ISRCTN57805470. FINDINGS: We identified 24 primary care clinics in Guarulhos that were willing to participate, of which 20 were randomly allocated to either the control group (ten [50%] clusters) or to the intervention group (ten [50%] clusters). The four remaining eligible clusters were kept as reserves. Between May 23, 2019, and Feb 21, 2020, 8146 individuals were assessed for eligibility, of whom 715 (8·8%) participants were recruited: 355 (49·7%) in the control group and 360 (50·3%) in the intervention group. 284 (80·0%) participants in the control group and 253 (70·3%) in the intervention group completed follow-up at 8 months. At 8-month follow-up, 158 (62·5%) participants in the intervention group showed recovery from depression (PHQ-9 score <10) compared with 125 (44·0%) in the control group (adjusted odds ratio 2·16 [95% CI 1·47-3·18]; p<0·0001). These findings were maintained in the complete case analysis. No adverse events related to the intervention were observed. INTERPRETATION: Although the COVID-19 pandemic altered delivery of the intervention, the low-intensity psychosocial intervention delivered mainly by non-mental health professionals was highly efficacious in improving recovery from depression in older adults in Brazil. Our results support a low-resource intervention that could be useful to reduce the treatment gap for depression among older people in other LMICs. FUNDING: São Paulo Research Foundation and Joint Global Health Trials (UK Department for International Development, Medical Research Council, and the Wellcome Trust).

Digital psychosocial intervention for depression among older adults in socioeconomically deprived areas in Brazil (PRODIGITAL-D): protocol for an individually randomised controlled trial.

BACKGROUND: Depression in older adults is a challenge for health systems in most low- and middle-income countries (LMICs). Digital strategies for the management of this condition have been emerging worldwide, but the effectiveness of most of them is still unclear, especially among older adults. Thus, we aim to assess the effectiveness and cost-effectiveness of a digital psychosocial intervention to treat depression among older adults living in socioeconomically deprived areas in Guarulhos, Brazil. METHODS: We will conduct a two-arm individually randomised controlled trial with 1:1 allocation ratio. Five hundred older adults aged 60 years or over with depressive symptomatology (9-item Patient Health Questionnaire score, PHQ-9 ≥ 10) and registered with one of the primary care clinics will be recruited to participate in this study. A 6-week digital psychosocial programme, named Viva Vida, will be delivered via WhatsApp to participants allocated to the intervention arm. The Viva Vida will send psychoeducational and behavioural activation audio and visual messages 4 days a week for 6 weeks. The control arm will only receive a single message with general information about depression. The primary outcome will be the proportion of depression recovery (PHQ-9 < 10) assessed at 3 months. The cost-effectiveness of the intervention will be assessed at 5 months. A detailed process evaluation will be used to explore context and important implementation outcomes. DISCUSSION: This programme was based on the PROACTIVE intervention and designed to be delivered without face-to-face contact. If effective, it could be a simple treatment option, appropriate not only when social distancing is required, but it could also be included as a regular public health programme to initiate depression treatment, particularly in LMICs where resources allocated to mental health are scarce. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos (ReBEC), RBR-4c94dtn. Registered on 22 October 2021 (submitted on 03 August 2021).

A Validation Study of the EQ-5D-5L and ICEpop Capability Measure for Older People Among Older Individuals With Depressive Symptoms in Brazil.

OBJECTIVES: This study aimed to assess the known-groups validity of the EQ-5D-5L and the ICEpop Capability Measure for Older People (ICECAP-O), 2 outcome measures used in economic evaluation, among older adults with depressive symptoms in socioeconomically deprived areas of Brazil. We also explored the role of education and income on responses to these measures. METHODS: This cross-sectional study used baseline data from PROACTIVE, a cluster randomized controlled trial to evaluate a psychosocial intervention for late-life depression among older adults. Participants aged ≥60 years with a 9-item Patient Health Questionnaire score ≥10 were recruited from 20 primary healthcare clinics. Ordered logistic regression models assessed the association between depressive symptoms severity, income, and education and dimension-level responses on the EQ-5D-5L and ICECAP-O. Multivariable regression models investigated the ability of EQ-5D-5L and ICECAP-O scores to discriminate between depressive symptoms severity levels and other characteristics, including education level and household income. RESULTS: A total of 715 participants were included in the study. Depressive symptoms severity was associated with all EQ-5D-5L and ICECAP-O dimensions, except the ICECAP-O enjoyment attribute. In contrast, household income was only associated with the ICECAP-O security attribute. Higher severity of depressive symptoms (9-item Patient Health Questionnaire scores) was also strongly associated with lower (ie, worse) scores on both measures in all models. Education level and household income showed no association with either EQ-5D-5L or ICECAP-O scores. CONCLUSIONS: To best of our knowledge, this is the first study that investigated the validity of these 2 measures among older adults in Brazil. Both EQ-5D-5L and ICECAP-O showed evidence of validity in differentiating depressive symptom severity.

Depressive and subthreshold depressive symptomatology among older adults in a socioeconomically deprived area in Brazil.

Depressive and subthreshold depressive symptomatology are common but often neglected in older adults. OBJECTIVE: This study aimed to assess rates of depressive and subthreshold depressive symptomatology, and the characteristics associated, among older adults living in a socioeconomically deprived area of Brazil. METHODS: This study is part of the PROACTIVE cluster randomised controlled trial. 3356 adults aged 60+ years and registered in 20 primary health clinics were screened for depressive symptomatology with the Patient Health Questionnaire-9 (PHQ-9). Depressive status was classified according to the total PHQ-9 score and the presence of core depressive symptoms (depressed mood and anhedonia) as follows: no depressive symptomatology (PHQ-9 score 0-4, or 5-9 but with no core depressive symptom); subthreshold depressive symptomatology (PHQ-9 score 5-9 and at least one core depressive symptom); and depressive symptomatology (PHQ-9 score ≥ 10). Sociodemographic information and self-reported chronic conditions were collected. Relative risk ratios and 95% CIs were obtained using a multinomial regression model. RESULTS: Depressive and subthreshold depressive symptomatology were present in 30% and 14% of the screened sample. Depressive symptomatology was associated with female gender, low socioeconomic conditions and presence of chronic conditions, whereas subthreshold depressive symptomatology was only associated with female gender and having hypertension. CONCLUSIONS: Depressive and subthreshold depressive symptomatology is highly prevalent in this population registered with primary care clinics. Strategies managed by primary care non-mental health specialists can be a first step for improving this alarming and neglected situation among older adults.

Acceptability and fidelity of a psychosocial intervention (PROACTIVE) for older adults with depression in a basic health unit in São Paulo, Brazil: a qualitative study.

BACKGROUND: Depression is a common condition in older adults, being often detected and treated initially in primary care. Collaborative care models including, for example, task-shifting and stepped-care approaches have been investigated to overcome the current scarcity of strategies and trained mental health professionals to treat depression. The PROACTIVE study developed a psychosocial intervention, which makes extensive use of technology in an intervention delivered mainly by non-specialists to treat older adults with depression. The aim of this qualitative study is to assess: 1. Health workers' fidelity to the intervention protocol; 2. Acceptability of the psychosocial intervention from the viewpoint of older adult participants; and 3. Perceptions of the psychosocial intervention by the health workers. METHODS: Qualitative methods were used to achieve our aims. The sample included participants (N = 31) receiving the intervention in the pilot trial and health workers (N = 11) working in a Basic Health Unit in the northern area of São Paulo, Brazil. Focus group, non-participant observation and structured interviews were used. Data were analysed using a thematic analysis approach. RESULTS: 1. Health workers' fidelity to the intervention protocol: training, supervision and the structured intervention were crucial and guaranteed health workers' fidelity to the protocol. 2. Acceptability of the psychosocial intervention from the viewpoint of older adult participants: Collaborative care, task-shifting, and stepped-care approaches were well accepted. The structured protocol of the intervention including different activities and videos was important to adherence of older adult participants 3. Perceptions of the psychosocial intervention by the health workers: It was feasible to have the home psychosocial sessions conducted by health workers, who are non-mental health specialists and received 3-day training. Training and supervision were perceived as crucial to support health workers before and during the intervention. Technology served as a tool to structure the sessions, obtain and store patient data, present multi-media content, guarantee fidelity to the protocol and facilitate communication among members of the team. However, extra burden was mentioned by the health workers indicating the need of adjustments in their daily duties. CONCLUSIONS: The PROACTIVE intervention was demonstrated to be feasible and accepted by both health workers and older adult participants. The qualitative assessments suggested improvements in training and supervision to ensure fidelity to protocol. To assess effectiveness a randomised controlled trial of the intervention will be conducted with the addition of improvements suggested by this qualitative study. TRIAL REGISTRATION: The pilot study of which the present study gives support to was registered at the Brazilian Clinical Trials, UTN code: U1111-1218-6717 on 26/09/2018.

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.

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.