'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 ).

Patient Health Questionnaire-9 Item Pairing Predictiveness for Prescreening Depressive Symptomatology: Machine Learning Analysis.

BACKGROUND: Anhedonia and depressed mood are considered the cardinal symptoms of major depressive disorder. These are the first 2 items of the Patient Health Questionnaire (PHQ)-9 and comprise the ultrabrief PHQ-2 used for prescreening depressive symptomatology. The prescreening performance of alternative PHQ-9 item pairings is rarely compared with that of the PHQ-2. OBJECTIVE: This study aims to use machine learning (ML) with the PHQ-9 items to identify and validate the most predictive 2-item depressive symptomatology ultrabrief questionnaire and to test the generalizability of the best pairings found on the primary data set, with 6 external data sets from different populations to validate their use as prescreening instruments. METHODS: All 36 possible PHQ-9 item pairings (each yielding scores of 0-6) were investigated using ML-based methods with logistic regression models. Their performances were evaluated based on the classification of depressive symptomatology, defined as PHQ-9 scores ≥10. This gave each pairing an equal opportunity and avoided any bias in item pairing selection. RESULTS: The ML-based PHQ-9 items 2 and 4 (phq2&4), the depressed mood and low-energy item pairing, and PHQ-9 items 2 and 8 (phq2&8), the depressed mood and psychomotor retardation or agitation item pairing, were found to be the best on the primary data set training split. They generalized well on the primary data set test split with area under the curves (AUCs) of 0.954 and 0.946, respectively, compared with an AUC of 0.942 for the PHQ-2. The phq2&4 had a higher AUC than the PHQ-2 on all 6 external data sets, and the phq2&8 had a higher AUC than the PHQ-2 on 3 data sets. The phq2&4 had the highest Youden index (an unweighted average of sensitivity and specificity) on 2 external data sets, and the phq2&8 had the highest Youden index on another 2. The PHQ-2≥2 cutoff also had the highest Youden index on 2 external data sets, joint highest with the phq2&4 on 1, but its performance fluctuated the most. The PHQ-2≥3 cutoff had the highest Youden index on 1 external data set. The sensitivity and specificity achieved by the phq2&4 and phq2&8 were more evenly balanced than the PHQ-2≥2 and ≥3 cutoffs. CONCLUSIONS: The PHQ-2 did not prove to be a more effective prescreening instrument when compared with other PHQ-9 item pairings. Evaluating all item pairings showed that, compared with alternative partner items, the anhedonia item underperformed alongside the depressed mood item. This suggests that the inclusion of anhedonia as a core symptom of depression and its presence in ultrabrief questionnaires may be incompatible with the empirical evidence. The use of the PHQ-2 to prescreen for depressive symptomatology could result in a greater number of misclassifications than alternative item pairings.

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).

Diet quality in cystic fibrosis - associations with patient reported outcome measures and enablers and barriers to eating a healthy diet: A protocol paper for a mixed methods study.

Background: People with cystic fibrosis (PWCF) have increased energy requirements. However, in recent years concerns have emerged regarding the 'cystic fibrosis (CF) diet' in terms of reliance on energy-dense, nutrient poor foods, which tend to be higher in saturated fat, sugar, and salt. These foods lack essential nutrients and are aetiologically linked with diet-related chronic diseases. The aim is to explore habitual dietary intakes in PWCF and (i) assess adherence to CF dietary guidelines and population specific healthy eating guidelines; (ii) derive a diet quality score and the inflammatory potential for the average diet consumed by PWCF and assess associations with patient reported outcome measures; (iii) assess drivers for current consumption patterns and enablers and barriers to eating a healthy diet. Methods: The aim is to recruit between 100-180 PWCF. A mixed methods study will be performed. Using three-day food diaries and food frequency questionnaires, aims (i) and (ii) will be addressed. The Dietary Approaches to Stop Hypertension (DASH) score and Healthy Eating Index-International (HEI-I) will derive diet quality scores. The Dietary Inflammatory Index (DII®) will ascertain inflammatory potential of the diet. Validated questionnaires will be used to report health related quality of life measures. Online focus groups and semi-structured interview with PWCF will address aim (iii). Conclusions: It is timely to revise dietary priorities and targets for CF. However, a greater understanding of what adults with CF currently consume and what they require in terms of nutrition and dietary guidance into the future is needed. In doing so, this research will help to clarify nutrition priorities and simplify the dietary aspects of CF treatment, thereby supporting adherence.

Sensing Apps and Public Data Sets for Digital Phenotyping of Mental Health: Systematic Review.

BACKGROUND: Mental disorders are normally diagnosed exclusively on the basis of symptoms, which are identified from patients' interviews and self-reported experiences. To make mental health diagnoses and monitoring more objective, different solutions have been proposed such as digital phenotyping of mental health (DPMH), which can expand the ability to identify and monitor health conditions based on the interactions of people with digital technologies. OBJECTIVE: This article aims to identify and characterize the sensing applications and public data sets for DPMH from a technical perspective. METHODS: We performed a systematic review of scientific literature and data sets. We searched 8 digital libraries and 20 data set repositories to find results that met the selection criteria. We conducted a data extraction process from the selected articles and data sets. For this purpose, a form was designed to extract relevant information, thus enabling us to answer the research questions and identify open issues and research trends. RESULTS: A total of 31 sensing apps and 8 data sets were identified and reviewed. Sensing apps explore different context data sources (eg, positioning, inertial, ambient) to support DPMH studies. These apps are designed to analyze and process collected data to classify (n=11) and predict (n=6) mental states/disorders, and also to investigate existing correlations between context data and mental states/disorders (n=6). Moreover, general-purpose sensing apps are developed to focus only on contextual data collection (n=9). The reviewed data sets contain context data that model different aspects of human behavior, such as sociability, mood, physical activity, sleep, with some also being multimodal. CONCLUSIONS: This systematic review provides in-depth analysis regarding solutions for DPMH. Results show growth in proposals for DPMH sensing apps in recent years, as opposed to a scarcity of public data sets. The review shows that there are features that can be measured on smart devices that can act as proxies for mental status and well-being; however, it should be noted that the combined evidence for high-quality features for mental states remains limited. DPMH presents a great perspective for future research, mainly to reach the needed maturity for applications in clinical settings.

Measurement Properties of Smartphone Approaches to Assess Diet, Alcohol Use, and Tobacco Use: Systematic Review.

BACKGROUND: Poor diet, alcohol use, and tobacco smoking have been identified as strong determinants of chronic diseases, such as cardiovascular disease, diabetes, and cancer. Smartphones have the potential to provide a real-time, pervasive, unobtrusive, and cost-effective way to measure these health behaviors and deliver instant feedback to users. Despite this, the validity of using smartphones to measure these behaviors is largely unknown. OBJECTIVE: The aim of our review is to identify existing smartphone-based approaches to measure these health behaviors and critically appraise the quality of their measurement properties. METHODS: We conducted a systematic search of the Ovid MEDLINE, Embase (Elsevier), Cochrane Library (Wiley), PsycINFO (EBSCOhost), CINAHL (EBSCOHost), Web of Science (Clarivate), SPORTDiscus (EBSCOhost), and IEEE Xplore Digital Library databases in March 2020. Articles that were written in English; reported measuring diet, alcohol use, or tobacco use via a smartphone; and reported on at least one measurement property (eg, validity, reliability, and responsiveness) were eligible. The methodological quality of the included studies was assessed using the Consensus-Based Standards for the Selection of Health Measurement Instruments Risk of Bias checklist. Outcomes were summarized in a narrative synthesis. This systematic review was registered with PROSPERO, identifier CRD42019122242. RESULTS: Of 12,261 records, 72 studies describing the measurement properties of smartphone-based approaches to measure diet (48/72, 67%), alcohol use (16/72, 22%), and tobacco use (8/72, 11%) were identified and included in this review. Across the health behaviors, 18 different measurement techniques were used in smartphones. The measurement properties most commonly examined were construct validity, measurement error, and criterion validity. The results varied by behavior and measurement approach, and the methodological quality of the studies varied widely. Most studies investigating the measurement of diet and alcohol received very good or adequate methodological quality ratings, that is, 73% (35/48) and 69% (11/16), respectively, whereas only 13% (1/8) investigating the measurement of tobacco use received a very good or adequate rating. CONCLUSIONS: This review is the first to provide evidence regarding the different types of smartphone-based approaches currently used to measure key behavioral risk factors for chronic diseases (diet, alcohol use, and tobacco use) and the quality of their measurement properties. A total of 19 measurement techniques were identified, most of which assessed dietary behaviors (48/72, 67%). Some evidence exists to support the reliability and validity of using smartphones to assess these behaviors; however, the results varied by behavior and measurement approach. The methodological quality of the included studies also varied. Overall, more high-quality studies validating smartphone-based approaches against criterion measures are needed. Further research investigating the use of smartphones to assess alcohol and tobacco use and objective measurement approaches is also needed. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1186/s13643-020-01375-w.

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.

Measurement properties of smartphone approaches to assess key lifestyle behaviours: protocol of a systematic review.

BACKGROUND: Six core behavioural risk factors (poor diet, physical activity, sedentary behaviour, alcohol misuse, smoking and unhealthy sleep patterns) have been identified as strong determinants of chronic disease, such as cardiovascular disease, diabetes and cancers. Smartphones have the potential to provide a real-time, pervasive, unobtrusive and cost-effective way to measure health behaviours and deliver instant feedback to users. Despite this, validity of using smartphones to measure these six key behaviours is largely unknown. The proposed systematic review aims to address this gap by identifying existing smartphone-based approaches to measure these health behaviours and critically appraising, comparing and summarizing the quality of their measurement properties. METHODS: A systematic search of the Ovid MEDLINE, Embase (Elsevier), Cochrane Library (Wiley), PsychINFO (EBSCOhost), CINAHL (EBSCOHost), Web of Science (Clarivate), SPORTDiscus (EBSCOhost) and IEEE Xplore Digital Library databases will be conducted from January 2007 to March 2020. Eligible studies will be those written in English that measure at least one of the six health behaviours of interest via a smartphone and report on at least one measurement property. The primary outcomes will be validity, reliability and/or responsiveness of these measurement approaches. A secondary outcome will be the feasibility (e.g. user burden, usability and cost) of identified approaches. No restrictions will be placed on the participant population or study design. Two reviewers will independently screen studies for eligibility, extract data and assess the risk of bias. The study methodological quality (or bias) will be appraised using an appropriate tool. Our results will be described in a narrative synthesis. If feasible, random effects meta-analysis will be conducted where appropriate. DISCUSSION: The results from this review will provide important information about the types of smartphone-based approaches currently available to measure the core behavioural risk factors for chronic disease and the quality of their measurement properties. It will allow recommendations on the most suitable and effective measures of these lifestyle behaviours using smartphones. Valid and reliable measurement of these behaviours and risk factor opens the door to targeted and real-time delivery of health behaviour interventions, providing unprecedented opportunities to offset the trajectory toward chronic disease. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42019122242.

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.

Using Mobile Phones to Examine and Enhance Perceptions of Control in Mildly Depressed and Nondepressed Volunteers: Intervention Study.

BACKGROUND: Perceived control is strongly linked to healthy outcomes, mental healthiness, and psychological well-being. This is particularly important when people have little control over things that are happening to them. Perceived control studies have been performed extensively in laboratory settings and show that perceived control can be increased by experimental manipulations. Although these studies suggest that it may be possible to improve people's mental health by increasing their perceived control, there is very little evidence to date to suggest that perceived control can also be influenced in the real world. OBJECTIVE: The first aim of this study was to test for evidence of a link between noncontrol situations and psychological well-being in the real world using a mobile phone app. The second and arguably more important aim of the study was to test whether a simple instructional intervention on the nature of alternative causes would enhance people's perceptions of their own control in these noncontrol situations. METHODS: We implemented a behavioral action-outcome contingency judgment task using a mobile phone app. An opportunity sample of 106 healthy volunteers scoring low (n=56, no depression) or high (n=50, mild depression) on a depression scale participated. They were given no control over the occurrence of a low- or high-frequency stimulus that was embedded in everyday phone interactions during a typical day lasting 8 hours. The intervention involved instructions that either described a consistent alternative cause against which to assess their own control, or dynamic alternative causes of the outcome. Throughout the day, participants rated their own control over the stimulus using a quantitative judgment scale. RESULTS: Participants with no evidence of depression overestimated their control, whereas those who were most depressed were more accurate in their control ratings. Instructions given to all participants about the nature of alternative causes significantly affected the pattern of perceived control ratings. Instructions describing discrete alternative causes enhanced perceived control for all participants, whereas dynamic alternative causes were linked to less perceived control. CONCLUSIONS: Perceptions of external causes are important to perceived control and can be used to enhance people's perceptions. Theoretically motivated interventions can be used to enhance perceived control using mobile phone apps. This is the first study to do so in a real-world setting.

Enriching Mental Health Mobile Assessment and Intervention with Situation Awareness.

Current mobile devices allow the execution of sophisticated applications with the capacity for identifying the user situation, which can be helpful in treatments of mental disorders. In this paper, we present SituMan, a solution that provides situation awareness to MoodBuster, an ecological momentary assessment and intervention mobile application used to request self-assessments from patients in depression treatments. SituMan has a fuzzy inference engine to identify patient situations using context data gathered from the sensors embedded in mobile devices. Situations are specified jointly by the patient and mental health professional, and they can represent the patient's daily routine (e.g., "studying", "at work", "working out"). MoodBuster requests mental status self-assessments from patients at adequate moments using situation awareness. In addition, SituMan saves and displays patient situations in a summary, delivering them for consultation by mental health professionals. A first experimental evaluation was performed to assess the user satisfaction with the approaches to define and identify situations. This experiment showed that SituMan was well evaluated in both criteria. A second experiment was performed to assess the accuracy of the fuzzy engine to infer situations. Results from the second experiment showed that the fuzzy inference engine has a good accuracy to identify situations.

ULTEMAT: A mobile framework for smart ecological momentary assessments and interventions.

In this paper we introduce a new Android library, called ULTEMAT, for the delivery of ecological momentary assessments (EMAs) on mobile devices and we present its use in the MoodBuster app developed in the H2020 E-COMPARED project. We discuss context-aware, or event-based, triggers for the presentation of EMAs and discuss the potential they have to improve the effectiveness of mobile provision of mental health interventions as they allow for the delivery of assessments to the patients when and where these are most appropriate. Following this, we present the abilities of ULTEMAT to use such context-aware triggers to schedule EMAs and we discuss how a similar approach can be used for Ecological Momentary Interventions (EMIs).

Reliability of a measurement method for the cross-sectional area of the longus colli using real-time ultrasound imaging.

OBJECTIVE: Real-time ultrasound imaging is an established objective outcome measurement with proven reliability. However, it is still largely biased by user-ability. Published research in the area of real-time ultrasound imaging reliability in the cervical region and in particular the deep cervical flexors is quite sparse. The purpose of this investigation was to examine if a novice ultrasound user could agree favourably with an experienced ultrasound sonographer in measuring the cross-sectional area of the longus colli. METHODS: Ultrasound images were captured from 22 healthy subjects on two different occasions, one week apart, by a novice ultrasound user. They were acquired using a GE Healthcare LOGIQe ultrasound machine, at a depth of 3-4 cm with the transducer frequency set to 8 MHz, in line with previous research guidelines. Cross-sectional area was then measured on-screen by both a novice and experienced ultrasound user to determine inter-rater reliability. Intra-rater reliability was also analysed using cross-sectional area figures from days one and two. RESULTS: Intra-rater reliability for real-time ultrasound imaging for the cross-sectional area of the longus colli was "excellent" (intra-class correlation 0.90, 95% CI 0.82-0.95). Inter-rater reliability was "moderate" but in keeping with previous published research (intra-class correlation 0.61, 95% CI 0.37-0.77). CONCLUSION: Difficulties in identifying the borders of the longus colli muscle due to its deep anatomical location and surrounding structures make it difficult for assessors to agree favourably on cross-sectional area measurements, leading to "moderate" levels of inter-rater reliability and poor agreement. Intra-rater reliability is excellent, and in this instance indicates that a novice user can be just as reliable as a more experienced ultrasound user.

Video analysis validation of a real-time physical activity detection algorithm based on a single waist mounted tri-axial accelerometer sensor.

We have validated a real-time activity classification algorithm based on monitoring by a body worn system which is potentially suitable for low-power applications on a relatively computationally lightweight processing unit. The algorithm output was validated using annotation data generated from video recordings of 20 elderly volunteers performing both a semi-structured protocol and a free-living protocol. The algorithm correctly identified sitting 75.1% of the time, standing 68.8% of the time, lying 50.9% of the time, and walking and other upright locomotion 82.7% of the time. This is one of the most detailed validations of a body worn sensor algorithm to date and offers an insight into the challenges of developing a real-time physical activity classification algorithm for a tri-axial accelerometer based sensor worn at the waist.