Clinical predictors of suicidal ideation, suicide attempts and suicide death in depressive disorder: a systematic review and meta-analysis.

Patients with depressive disorders are especially prone to suicide risk. Among the clinical predictors of suicidality, those specifically related to depressive disorders have not been accurately detailed. Our aim was to conduct a systematic review and meta-analysis of studies reporting longitudinal predictors of suicidal ideation, suicide attempts and suicide death within depression, including diagnostic subtypes, symptoms, clinical course, and assessment scales. A systematic search of the literature between 2001 and 2022 identified 4422 references, among which 19 studies providing 45 different predictors of suicidality met the inclusion criteria. Random effects meta-analyses were performed for 22 predictors, three for suicidal ideation, eleven for suicide attempts and eight for suicide death. Heterogeneity and publication bias were inspected through I2 tests and Egger's tests respectively. Meta-analysis results showed that severity of hopelessness predicted suicidal ideation and suicide attempts. History of suicide attempts, suicidal ideation, severe depression, and psychotic symptoms predicted subsequent suicide attempts and suicide death. Time to full remission and sleep disturbances were also found as relevant predictors of future suicide behaviours. This review specifies which predictors of suicidality within the clinical features of depression will help clinicians and policy makers to better prevent suicide risk in patients with depressive disorders. Further longitudinal studies are needed to reliably assess the predictive ability of our results and to analyse other possible clinical predictors to prevent suicidality, especially with regard to suicidal ideation.

Detection and treatment of depressive disorder in the spanish health system: a critical review.

Health care for depression is a major challenge. The aim of this review is to capture the status of the detection, diagno- sis and treatment of depression in the Spanish public health system. The data from the latest National Health Survey (ENSE 2017) have been analyzed and a non-systematic search for publications has been carried out in the PubMed and Scopus databases. We highlight the high specificity and low sensitivity in the detection of cases of major depression by Primary Care (PC) physicians in Spain. The detection of depression is supe- rior in specialized care compared to PC. The new healthcare systems based on the shared approach and the hierarchical model of screening, diagnosis and referral are reviewed and we present improvement proposals based on various programs and models of healthcare for depression.

Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial.

AIM: To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain. DESIGN: We will carry out a two-week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention. METHODS: The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID-19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire-primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation. DISCUSSION: Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context. IMPACT: Despite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits. CLINICAL TRIAL REGISTRATION: NCT04393818 (ClinicalTrials.gov identifier). APPROVED FUNDING: May 2020.

Suicidal risk and executive functions in major depressive disorder: a study protocol.

BACKGROUND: Suicide is a serious public health concern. Depression is the main gateway to suicidal behavior. The already established relationship between depression and suicidal risk should now focus on the investigation of more specific factors: recent studies have suggested an association between vulnerability to suicidal behavior and neurocognitive alterations, a nuclear symptom of depression. This project aims to identify alterations in the Executive Functions (EF) of patients suffering a first depressive episode that might constitute a risk factor for suicidal ideation, suicidal attempts and suicide, to allow for more adequate suicide prevention. METHODS: Prospective longitudinal design involving two groups (first depressive episodes with and without alterations in their EF) and four repeated measures (0, 6, 12 and 24 months). The estimated minimum sample size is 216 subjects. The variables and measurement instruments will include socio-demographic variables, clinical variables (age of illness onset, family and personal antecedents, psychopathological and medical comorbidity, suicidal ideation, suicide attempts and completed suicides, severity of depression, including melancholic or atypical, remission of the depressive episode), and neuropsychological variables (EF and decision-making processes evaluated through the Cambridge Neuropsychological Test Automated Battery (CANTAB)). DISCUSSION: First and foremost, the identification of clinical and neuropsychological risk factors associated with suicidal behavior will open the possibility to prevent such behavior in patients with a first depressive episode in the context of clinical practice. Secondly, interventions aimed at cognitive impairment (in particular: EF) derived from the study may be incorporated into strategies for the prevention of suicidal behavior. Finally, impaired neurocognitive function (even in early stages) could become an identifiable endophenotype or "marker" in clinical and neurobiological studies about suicidal behavior in depressive patients.

Effects of mindfulness-based interventions on biomarkers in healthy and cancer populations: a systematic review.

BACKGROUND: Only a small number of articles have investigated the relationship between mindfulness-based interventions (MBIs) and biomarkers. The aim of this systematic review was to study the effect of MBIs on specific biomarkers (cytokines, neuropeptides and C-reactive protein (CRP)) in both healthy subjects and cancer patients. METHODS: A search was conducted using PubMed, EMBASE, PsycINFO and the Cochrane library between 1980 and September 2016. RESULTS: A total of 13 studies with 1110 participants were included. In the healthy population, MBIs had no effect on cytokines, but were found to increase the levels of the neuropeptide insulin-like growth factor 1 (IGF-1). With respect to neuropeptide Y, despite the absence of post-intervention differences, MBIs may enhance recovery from stress. With regard to CRP, MBIs could be effective in lower Body Mass Index (BMI) individuals. In cancer patients, MBIs seem to have some effect on cytokine levels, although it was not possible to determine which specific cytokines were affected. One possibility is that MBIs might aid recovery of the immune system, increasing the production of interleukin (IL)-4 and decreasing interferon gamma (IFN-γ). CONCLUSIONS: MBIs may be involved in changes from a depressive/carcinogenic profile to a more normalized one. However, given the complexity and different contexts of the immune system, and the fact that this investigation is still in its preliminary stage, additional randomized controlled trials are needed to further establish the impact of MBI programmes on biomarkers in both clinical and non-clinical populations.

Effect of first episode axis I disorders on quality of life.

Cross-sectional studies indicate that mental disorders are inversely associated with quality of life (QoL) and that the magnitude of the negative correlation varies across disorders. The aims of this study were to examine whether QoL decreases after new onset of psychiatric disorders and to characterize variations across disorders. Data were drawn from a longitudinal study representative of the adult US population. Changes were examined in QoL, as measured by the Short Form-12 version 2, after incidence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), disorders at wave 2 in individuals without the given disorder at wave 1. A subanalysis examined change of QoL after incidence of mental disorders in individuals without a history of any mental disorder. With the exception of alcohol abuse, new incidence of each examined DSM-IV disorder was associated with a decrement in QoL, being the largest for major depressive disorder and generalized anxiety disorder. Incidence of these disorders was associated with a decrease in QoL even in individuals without history or presence of any other mental disorder. Although the incidence of most DSM-IV disorders is associated with a decrement in QoL, mood and anxiety disorders have the largest impact.

Psychometric properties of Spanish version of QIDS-SR16 in depressive patients.

INTRODUCTION: Depression is a worldwide health problem. Thus, making the diagnosis with reliable and short tests is crucial. In this regard, the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) has been validated in several countries. It was found that this instrument has a correct balance between time and reliability. This study has aimed to assess psychometric properties of QIDS-SR16 Spanish version, and to calculate several cutoffs to evaluate the depressive disorder severity. METHOD: The study was based on the data from the RESIST study that recruited 1595 depressive patients from 17 regional communities. Instruments used were Hamilton Depression Rating Scale (HDRS17) and Spanish version of QIDS-SR16. Statistical analyses included test-retest reliability and internal consistency calculation, and exploratory factor analysis. In addition, ROC curve was calculated in order to determine different cutoff values. RESULTS: QIDS-SR16 shows adequate test-retest reliability and high internal consistency (α=0.871), as well as ROC value of 0.946. Exploratory factor analysis showed a one factor model, which accounted for 46.80% of variance. Convergent validity and sensitivity to change were adequate. DISCUSSION: The results suggest that the QIDS-SR16 is a reliable test to assess depressive symptom severity in the Spanish population. The cutoff that shows the best sensitivity/specificity rate was a total score of 7.

Process evaluation of PsyCovidApp, a digital tool for mobile devices aimed at protecting the mental health of healthcare professionals during the COVID-19 pandemic: a mixed method study.

Introduction: PsyCovidApp, a digital intervention aimed at safeguarding the mental health of healthcare workers during the COVID-19 pandemic, demonstrated in a randomized clinical trial to yield significant improvements solely among healthcare workers undergoing psychotherapy or receiving psychotropic medication. Objectives: (1) To identify contextual factors and mechanisms of action that influenced the impact of PsyCovidApp during the aforementioned trial; (2) To pinpoint enhancements for optimizing its efficacy. Materials and methods: For the first objective, a process evaluation was conducted, amalgamating quantitative techniques (surveying 216 healthcare professionals who had utilized PsyCovidApp during the trial) and qualitative methods (in-depth interviews with 16 healthcare workers). The second objective involved a panel of seven experts, utilizing the RAND-UCLA methodology. Results: The quantitative study (response rate = 40%) revealed that 22% of respondents had not fully accessed the content of PsyCovidApp. The average usage time was 22.7 min/day, being higher (p < 0.05) among consumers of psychotropic medications. Contents related to relaxation and mindfulness were most highly rated. Acceptability and usefulness scores ranged between 7.3-7.5/10 points, with higher ratings (p < 0.05) among women and older healthcare workers. The qualitative study uncovered that the primary barriers to using PsyCovidApp were workload, lack of time, and exhaustion. Its primary mechanisms of action included emotion identification, mental health regulation (e.g., insomnia, intense emotions), and learning of techniques and skills. The expert panel reached a consensus on 29 proposals to optimize PsyCovidApp. Conclusion: The knowledge derived from this study could inform the design and implementation of future similar digital tools.

Factors associated with high and low mental well-being in Spanish university students.

BACKGROUND: Previous studies conducted in various nationally representative samples of the general population show that positive mental health is related to social prosperity. However, specific studies in university populations are scarce. In this study, we set out to explore factors associated with mental well-being (MWB) in a representative sample of first-year university students in Spain. METHODS: MWB was assessed with the short version of the Warwick-Edinburgh Mental Well-Being Scale. Multinomial logistic regressions were performed to explore the association between different blocks of factors, including relational, adversity, stress, lifestyle, spiritual, health, and self-perceived health variables with high and low MWB, controlling for sociodemographic and university-related variables. RESULTS: Data from 2082 students (18.6 ± 1.2 years; 56.6 % females) were analysed. Being male, being born in a foreign country, "high" self-perceived support, and "high" self-perceived mental health increased the odds of high MWB. Growing up in the suburbs, stressful experiences, and anxiety disorders reduced the odds of high MWB. Mood and anxiety disorders increased the odds of low MWB. "Middle" self-perceived support, sleeping ≥8 h per day, and "high" self-perceived mental health reduced the odds of low MWB. LIMITATIONS: The cross-sectional design precludes establishing causal relationships. Data were collected in the 2014-15 academic year using self-reported online surveys. CONCLUSION: The factors associated with high and low MWB do not always mirror each other, so specific plans are needed to successfully address each of the two poles. Interventions and policies targeting these factors for health promotion and disease prevention would improve the MWB of university students.

[Prevalence and factors associated to mental disorders in primary care attenders aged 75 and older]. / Prevalencia de trastornos mentales y factores asociados en pacientes de atención primaria mayores de 75 años.

BACKGROUND: Mental disorders in old age are a major public health problem. However, few epidemiological studies provide data on prevalence and risk factors of mental illness in older old population. The aim of this study is to assess the prevalence of common mental disorders and their associated factors in primary care patients over 75 years. METHOD: Cross-sectional epidemiologic study carried out in a sample of 426 older old patients who were attended at Primary Health Care settings, proportionally distributed for provinces and health centers. The Spanish version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) was used in order to diagnose the most common psychiatric disorders in this field. RESULTS: Prevalence and comorbidity rates of affective, anxiety and somatoform disorders are high. 47.4% of the sample presented one or more psychiatric disorder. The most prevalent were affective (33.8%), somatoform (24.4%) and anxiety (14.3%) disorders. 6.3% had comorbidity between affective, anxiety and somatoform disorders. Perceived health status and physical illnesses were significantly associated with these mental disorders. CONCLUSIONS: Affective, anxiety and somatoform disorders are highly prevalent in older old population with high rates of comorbidity. Their detection and treatment should be considered a relevant issue in primary care.

Blood alcohol level tests in nightlife recreational settings as a preventive tool.

BACKGROUND: Getting drunk is a common practice in the nightlife context and is related to risk behaviors. One potentially preventive strategy would be to conduct breathalyzer (blood alcohol content level-BAC) tests in situ, encouraging the young people to take responsibility. The aim of this study is to evaluate the efficacy of such a measure. METHOD: A sample of 555 young people were interviewed in the most popular nightlife recreational areas in three Spanish cities. After they answered to a brief questionnaire, the breathalyzer test was done and they were then informed of the results and also informed about the results, telling them what the maximum authorized rate of alcohol in expired air was for driving. After, they were asked about their drinking intentions for the rest of the night, and if they we going to be driving. RESULTS: Only 21.6% stated that they would stop drinking or drink less, while a similar percentage (21.5%) said they would drink even more than they had intended after finding out their BAC. The logistic regression indicated that the decision to drink more or less was influenced by the BAC level, the amount they had planned to drink prior to the test and high scores on "sensation seeking." Those who decided to drive had lower BAC levels and had planned to drink less prior to the interview. CONCLUSIONS: Prevention strategies involving attempts to change behavior through informing drinkers of their own BAC are controversial, since although for some it leads to their drinking less, in other cases the young people end up drinking more than they had planned.

Associations between unhealthy lifestyle and depression: Cross-sectional results from the Spanish National Health Survey.

INTRODUCTION: Depression usually worsens lifestyle habits, but previous evidence also suggests that an unhealthy lifestyle (UL) increases the risk of depression. Many studies have analyzed the association between lifestyle and depression in several nationally representative samples, but none have done so in the Spanish adult population. Our aim was to examine the associations between UL habits and depression in Spain. MATERIALS AND METHODS: Analysis of cross-sectional data from the latest National Health Survey published in 2018 (N=23,089). Data on depression and 4 lifestyle factors (diet, physical exercise, smoking, and alcohol consumption) were used. These factors were combined into an UL index ranging from 0 (healthiest lifestyle) to 4 (unhealthiest lifestyle). The prevalence of depression at different levels of the UL index, and the association between depression and both the cumulative UL index and the 4 UL factors was analyzed using parametric and non-parametric tests. RESULTS: Sedentarism was the most prevalent UL factor, followed by unhealthy diet, smoking and high-risk alcohol consumption. Having ≥1 UL factors was associated with a higher prevalence of depression compared to having 0 UL factors (2.5% vs. ≥5.2%), regardless of the cumulative number UL factors (1, 2, 3 or 4). Being physically inactive (OR=1.6) and a smoker (OR=1.3) increased the likelihood of depression. Being a high-risk wine drinker (OR=0.26) decreased the likelihood of depression. Dietary intake was not significant. CONCLUSIONS: The prevalence of depression changes depending on several modifiable lifestyle factors. Policy makers should therefore spare no resources in promoting strategies to encourage healthy lifestyles and prevent the acquisition of UL habits.

Soft Drinks and Symptoms of Depression and Anxiety in Overweight Subjects: A Longitudinal Analysis of an European Cohort.

BACKGROUND: Studies about the association of carbonated/soft drinks, coffee, and tea with depression and anxiety are scarce and inconclusive and little is known about this association in European adults. Our aim was to examine the association between the consumption of these beverages and depressive and anxiety symptom severity. METHODS: A total of 941 European overweight adults (mean age, 46.8 years) with subsyndromal depression that participated in the MooDFOOD depression prevention randomized controlled trial (Clinical Trials.gov identifier: NCT2529423; date of the study: from 2014 to 2018) were analyzed. Depressive and anxiety symptom severity and beverage consumption were assessed using multilevel mixed-effects ordinal logistic regression models for each beverage consumption (carbonated/soft drink with sugar, carbonated/soft drink with non-nutritive sweeteners, coffee, and tea) with the three repeated measures of follow-up (baseline and 6 and 12 months). A case report form for participants' sociodemographic and clinical characteristics, the Food Frequency Questionnaire, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder 7-Item Scale, the MINI International Neuropsychiatric Interview 5.0, the Short Questionnaire to Assess Health-Enhancing Psychical Activity, and the Alcohol Use Disorders Identification Test were the research tools used. RESULTS: Daily consumption of carbonated/soft drinks with sugar was associated with a higher level of anxiety. Trends towards significance were found for associations between both daily consumption of carbonated/soft drinks with sugar and non-nutritive sweeteners and a higher level of depression. No relationship was found between coffee and tea consumption and the level of depression and anxiety. CONCLUSIONS: The high and regular consumption of carbonated/soft drink with sugar (amount of consumption: ≥1 unit (200 mL)/day) tended to be associated with higher level of anxiety in a multicountry sample of overweight subjects with subsyndromal depressive symptoms. It is important to point out that further research in this area is essential to provide valuable information about the intake patterns of non-alcoholic beverages and their relationship with affective disorders in the European adult population.

Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial.

BACKGROUND: The high prevalence of depression is partly attributable to the poor response of patients to first-line antidepressants. Multimodal programs that promote a healthy lifestyle are successful in treating depression when used as a complementary therapy, but their medium- and long-term benefits have not been demonstrated for patients with treatment-resistant depression (TRD). The main aim of this study was to compare the effectiveness of a lifestyle modification program (LMP) with mindfulness-based cognitive therapy (MBCT) and a placebo-control (written suggestions for lifestyle changes) in Spanish patients with TRD. METHODS: This controlled clinical trial randomized 94 patients with TRD into 3 arms. The primary outcome was the Beck Depression Inventory-II (BDI-II) score at baseline, 2, 6 and 12 months. The secondary outcomes were changes in scores that evaluated quality-of-life, adherence to the Mediterranean diet, physical activity, and social support. RESULTS: Relative to the placebo group, the LMP and MBCT groups had significantly better quality of life (p = 0.017; p = 0.027), and the LMP group had significantly better adherence to the Mediterranean diet (p<0.001) and reduced use of antidepressants (p = 0.036). However, the three groups showed no significant differences in BDI-II score. LIMITATIONS: Only about half of the planned 180 patients were recruited, in part due to the COVID-19 pandemic. CONCLUSIONS: There was no evidence that the LMP treatment significantly reduced symptoms of depression relative to the other groups during the COVID-19 lockdown.

Mindfulness skills and experiential avoidance as therapeutic mechanisms for treatment-resistant depression through mindfulness-based cognitive therapy and lifestyle modification.

Background/objective: The COVID-19 pandemic and consequent physical distancing has made it difficult to provide care for those with Treatment-Resistant Depression (TRD). As a secondary analysis of a clinical trial, the aim of this study was to explore potential mechanisms through which three online-delivered approaches, added to treatment as usual, improve depressive symptoms in TRD patients. Methods: The three approaches included (a) Minimal Lifestyle Intervention (MLI), (b) Mindfulness-Based Cognitive Therapy (MBCT), and (c) Lifestyle Modification Program (LMP). Sixty-six participants with TRD completed assessments pre-post intervention (mindfulness skills [FFMQ]; self-compassion [SCS]; and experiential avoidance [AAQ-II]) and pre-intervention to follow-up (depressive symptoms [BDI-II]). Data were analyzed using within-subjects regression models to test mediation. Results: Mindfulness skills mediated the effect of MBCT on depressive symptoms (ab = -4.69, 95% CI = -12.93 to-0.32), whereas the lack of experiential avoidance mediated the effect of LMP on depressive symptoms (ab = -3.22, 95% CI = -7.03 to-0.14). Conclusion: Strengthening mindfulness skills and decreasing experiential avoidance may promote recovery in patients with TRD, MBCT, and LMP have demonstrated that they may help increase mindfulness skills and decrease experiential avoidance, respectively. Future work will need to unpick the components of these interventions to help isolate active ingredients and increase optimization.

Treatment patterns in major depressive disorder after an inadequate response to first-line antidepressant treatment.

BACKGROUND: The aim of the study was to determine the most common pharmacological strategies used in the management of major depressive disorder (MDD) after an inadequate response to first-line antidepressant treatment in clinical practice. METHODS: Multicenter, non-interventional study in adult outpatients with a DSM-IV-TR diagnosis of MDD and inadequate response to first-line antidepressant medication. Multiple logistic regression analyses were performed to identify independent factors associated with the adoption of a specific second-line strategy. RESULTS: A total of 273 patients were analyzed (mean age: 46.8 years, 67.8% female). Baseline mean Montgomery-Asberg Depression Rating Scale total score was 32.1 (95%CI 31.2-32.9). The most common strategies were: switching antidepressant medication (39.6%), augmentation (18.8%), and combination therapy (17.9%). Atypical antipsychotic drugs were the most commonly used agent for augmenting antidepressant effect. The presence of psychotic symptoms and the number of previous major depressive episodes were associated with the adoption of augmenting strategy (OR = 3.2 and 1.2, respectively). CONCLUSION: The switch to another antidepressant agent was the most common second-line therapeutic approach. Psychiatrists chose augmentation based on a worse patients' clinical profile (number of previous episodes and presence of psychotic symptoms).

Hygienic-dietary recommendations for major depression treatment: study protocol of a randomized controlled trial.

BACKGROUND: Depression is a highly prevalent and disabling mental disorder with an incidence rate which appears to be increasing in the developed world. This fact seems to be at least partially related to lifestyle factors. Some hygienic-dietary measures have shown their efficacy as a coadjuvant of standard treatment. However, their effectiveness has not yet been proved enough in usual clinical practice. METHODS: Multicenter, randomized, controlled, two arm-parallel, clinical trial involving 300 patients over 18 years old with a diagnosis of Major Depression. Major depression will be diagnosed by means of the Mini-International Neuropsychiatric Interview. The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome. Quality of Life and Social and Health Care Services Consumption Scales will be also administered. Patients will be assessed at three different occasions: baseline, 6-month follow-up and 12-month follow-up. DISCUSSION: We expect the patients in the active lifestyle recommendations group to experience a greater improvement in their depressive symptoms and quality of life with lower socio-sanitary costs. TRIAL REGISTRATION: ISRCTN73931675.

Health and access to healthcare in homeless people: Protocol for a mixed-methods study.

BACKGROUND: Homelessness is a more complex problem than the simple lack of a place to live. Homeless people (HP) often suffer from poor health and premature death due to their limited access healthcare, and are also deprived of basic human and social rights. The study protocol described here aims to evaluate the complex relationship between homelessness and health, and identify the barriers and facilitators that impact access to healthcare by HP. METHODS: This is a mixed-methods study that uses an explanatory sequential design. The first phase will consist of a cross-sectional study of 300 HP. Specific health questionnaires will be used to obtain information on health status, challenges during the COVID-19 pandemic, self-reported use of healthcare, diagnoses and pharmacologic treatments, substance abuse (DAST-10), diet quality (IASE), depression (PHQ-9), and human basic needs and social support (SSQ-6). The second phase will be a qualitative study of HP using the "life story" technique with purposive sampling. We will determine the effects of different personal, family, and structural factors on the life and health status of participants. The interviews will be structured and defined using Nussbaum's capability approach. DISCUSSION: It is well-known that HP experience poor health and premature death, but more information is needed about the influence of the different specific social determinants of these outcomes and about the barriers and facilitators that affect the access of HP to healthcare. The results of this mixed methods study will help to develop global health strategies that improve the health and access to healthcare in HP.

Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. METHODS: In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). DISCUSSION: Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.