Influence of depression on survival of colorectal cancer patients drawn from a large prospective cohort.

OBJECTIVE: The prevalence of depressive symptoms immediately after the diagnosis of colorectal cancer (CRC) is high and has important implications both psychologically and on the course of the disease. The aim of this study is to analyse the association between depressive symptoms and CRC survival at 5 years after diagnosis. METHODS: This multicentre, prospective, observational cohort study was conducted on a sample of 2602 patients with CRC who completed the Hospital Anxiety and Depression Scale (HADS-D) at 5 years of follow-up. Survival was analysed using the Kaplan-Meier method and Cox regression models. RESULTS: According to our analysis, the prevalence of depressive symptoms after a CRC diagnosis was 23.8%. The Cox regression analysis identified depression as an independent risk factor for survival (HR = 1.47; 95% CI: 1.21-1.8), a finding which persisted after adjusting for sex (female: HR = 0.63; 95% CI: 0.51-0.76), age (>70 years: HR = 3.78; 95% CI: 1.94-7.36), need for help (yes: HR = 1.43; 95% CI: 1.17-1.74), provision of social assistance (yes: HR = 1.46; 95% CI: 1.16-1.82), tumour size (T3-T4: HR = 1.56; 95% CI: 1.22-1.99), nodule staging (N1-N2: HR = 2.46; 95% CI: 2.04-2.96), and diagnosis during a screening test (yes: HR = 0.71; 95% CI: 0.55-0.91). CONCLUSIONS: There is a high prevalence of depressive symptoms in patients diagnosed with CRC. These symptoms were negatively associated with the survival rate independently of other clinical variables. Therefore, patients diagnosed with CRC should be screened for depressive symptoms to ensure appropriate treatment can be provided.

The Impact of COVID-19 Confinement on Cognition and Mental Health and Technology Use Among Socially Vulnerable Older People: Retrospective Cohort Study.

BACKGROUND: COVID-19 forced the implementation of restrictive measures in Spain, such as lockdown, home confinement, social distancing, and isolation. It is necessary to study whether limited access to basic services and decreased family and social support could have deleterious effects on cognition, quality of life, and mental health in vulnerable older people. OBJECTIVE: This study aims to explore the impact of the COVID-19 outbreak on cognition in older adults with mild cognitive impairment or dementia as the main outcome and the quality of life, perceived health status, and depression as secondary outcomes and to analyze the association of living alone and a change in living arrangements with those outcomes and other variables related with the use of technology and health services. Likewise, this study aims to analyze the association of high and low technophilia with those variables, to explore the access and use of health care and social support services, and, finally, to explore the informative-, cognitive-, entertainment-, and socialization-related uses of information and communications technologies (ICTs) during the COVID-19 outbreak. METHODS: This cohort study was conducted in Málaga (Spain). In total, 151 participants with mild cognitive impairment or mild dementia, from the SMART4MD (n=75, 49.7%) and TV-AssistDem (n=76, 50.3%) randomized clinical trials, were interviewed by telephone between May 11 and June 26, 2020. All participants had undergone 1-3 assessments (in 6-month intervals) on cognition, quality of life, and mood prior to the COVID-19 breakout. RESULTS: The outbreak did not significantly impact the cognition, quality of life, and mood of our study population when making comparisons with baseline assessments prior to the outbreak. Perceived stress was reported as moderate during the outbreak. After correction for multiple comparisons, living alone, a change in living arrangements, and technophilia were not associated with negative mental health outcomes. However, being alone was nominally associated with self-perceived fear and depression, and higher technophilia with better quality of life, less boredom, perceived stress and depression, and also less calmness. Overall, health care and social support service access and utilization were high. The most used ICTs during the COVID-19 outbreak were the television for informative, cognitive, and entertainment-related uses and the smartphone for socialization. CONCLUSIONS: Our findings show that the first months of the outbreak did not significantly impact the cognition, quality of life, perceived health status, and depression of our study population when making comparisons with baseline assessments prior to the outbreak. Living alone and low technophilia require further research to establish whether they are risk factors of mental health problems during lockdowns in vulnerable populations. Moreover, although ICTs have proven to be useful for informative-, cognitive-, entertainment-, and socialization-related uses during the pandemic, more evidence is needed to support these interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/26431.

Effectiveness and implementation of an online intervention (MINDxYOU) for reducing stress and promote mental health among healthcare workers in Spain: a study protocol for a stepped-wedge cluster randomized trial.

BACKGROUND: The World Health Organization has formally recognized that healthcare professionals are at risk of developing mental health problems; finding ways to reduce their stress is mandatory to improve both their quality of life and, indirectly, their job performance. In recent years, particularly since the COVID-19 pandemic outbreak, there has been a proliferation of online interventions with promising results. The purpose of the present study is twofold: to test the effectiveness of an online, self-guided intervention, MINDxYOU, to reduce the stress levels of healthcare workers; and to conduct an implementation study of this intervention. Additionally, an economic evaluation of the intervention will be conducted. METHODS: The current study has a hybrid effectiveness-implementation type 2 design. A stepped wedge cluster randomized trial design will be used, with a cohort of 180 healthcare workers recruited in two Spanish provinces (Malaga and Zaragoza). The recruitment stage will commence in October 2022. Frontline health workers who provide direct care to people in a hospital, primary care center, or nursing home setting in both regions will participate. The effectiveness of the intervention will be studied, with perceived stress as the main outcome (Perceived Stress Scale), while other psychopathological symptoms and process variables (e.g., mindfulness, compassion, resilience, and psychological flexibility) will be also assessed as secondary outcomes. The implementation study will include analysis of feasibility, acceptability, adoption, appropriateness, fidelity, penetration, and sustainability. The incremental costs and benefits, in terms of quality-adjusted life years, will be examined by means of cost-utility and cost-effectiveness analyses. DISCUSSION: MINDxYOU is designed to reduce healthcare workers' stress levels through the practice of mindfulness, acceptance, and compassion, with a special focus on how to apply these skills to healthy habits and considering the particular stressors that these professionals face on a daily basis. The present study will show how implementation studies are useful for establishing the framework in which to address barriers to and promote facilitators for acceptability, appropriateness, adoption, feasibility, fidelity, penetration, and sustainability of online interventions. The ultimate goal is to reduce the research-to-practice gap. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov on 29/06/2022; registration number: NCT05436717.

Economic Evaluation of a Web Application Implemented in Primary Care for the Treatment of Depression in Patients With Type 2 Diabetes Mellitus: Multicenter Randomized Controlled Trial.

BACKGROUND: Depressive disorder and type 2 diabetes mellitus (T2DM) are prevalent in primary care (PC). Pharmacological treatment, despite controversy, is commonly chosen due to resource limitations and difficulties in accessing face-to-face interventions. Depression significantly impacts various aspects of a person's life, affecting adherence to medical prescriptions and glycemic control and leading to future complications and increased health care costs. To address these challenges, information and communication technologies (eg, eHealth) have been introduced, showing promise in improving treatment continuity and accessibility. However, while eHealth programs have demonstrated effectiveness in alleviating depressive symptoms, evidence regarding glycemic control remains inconclusive. This randomized controlled trial aimed to test the efficacy of a low-intensity psychological intervention via a web app for mild-moderate depressive symptoms in individuals with T2DM compared with treatment as usual (TAU) in PC. OBJECTIVE: This study aimed to analyze the cost-effectiveness and cost-utility of a web-based psychological intervention to treat depressive symptomatology in people with T2DM compared with TAU in a PC setting. METHODS: A multicenter randomized controlled trial was conducted with 49 patients with T2DM, depressive symptoms of moderate severity, and glycosylated hemoglobin (HbA1c) of 7.47% in PC settings. Patients were randomized to TAU (n=27) or a web-based psychological treatment group (n=22). This web-based treatment consisted of cognitive behavioral therapy, improvement of diabetes self-care behaviors, and mindfulness. Cost-effectiveness analysis for the improvement of depressive symptomatology was conducted based on reductions in 3, 5, or 50 points on the Patient Health Questionnaire-9 (PHQ-9). The efficacy of diabetes control was estimated based on a 0.5% reduction in HbA1c levels. Follow-up was performed at 3 and 6 months. The cost-utility analysis was performed based on quality-adjusted life years. RESULTS: Efficacy analysis showed that the web-based treatment program was more effective in improving depressive symptoms than TAU but showed only a slight improvement in HbA1c. Incremental cost-effectiveness ratios of 186.76 for a 3-point reduction in PHQ-9 and 206.31 for reductions of 5 and 50 percentage points were obtained. In contrast, the incremental cost-effectiveness ratio for improving HbA1c levels amounted to €1510.90 (€1=US $1.18 in 2018) per participant. The incremental cost-utility ratio resulted in €4119.33 per quality-adjusted life year gained. CONCLUSIONS: The intervention, using web-based modules incorporating cognitive behavioral therapy tools, diabetes self-care promotion, and mindfulness, effectively reduced depressive symptoms and enhanced glycemic control in patients with T2DM. Notably, it demonstrated clinical efficacy and economic efficiency. This supports the idea that eHealth interventions not only benefit patients clinically but also offer cost-effectiveness for health care systems. The study emphasizes the importance of including specific modules to enhance diabetes self-care behaviors in future web-based psychological interventions, emphasizing personalization and adaptation for this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03426709; https://clinicaltrials.gov/study/NCT03426709. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/S12888-019-2037-3.

Implementation of a psychological online intervention for low to moderate depression in primary care: study protocol.

Background: Depression affects millions of people all over the world and implies a great socioeconomic burden. Despite there are different effective evidence-based interventions for treating depression, only a small proportion of these patients receives an appropriate treatment. In this regard, information and communication technologies (ICTs) can be used with therapeutic aims and this can contribute to make interventions more accessible. One example is "Smiling is fun", an internet-based treatment which has proved to be effective and cost-effective for treating depression in Spanish Primary Care (PC). However, the "know-do gap" between research and clinical settings implies that the actual implementation of such interventions could last up to 20 years. To overcome this obstacle, the implementation research establishes the methodology to implement the advances developed in the laboratories to the health care services maintaining the validity of the intervention and offering specific strategies for the implementation process. Objective: This is the protocol of an implementation study for the Internet-based program "Smiling is fun", which will be conducted on patients with mild-to-moderate depression of Spanish PC settings. In the implementation study, the feasibility, efficacy, cost-efficacy, acceptability, adoption, appropriateness, fidelity, penetration, normalization, and sustainability will be assessed. Methods: The current investigation is a Hybrid Effectiveness-Implementation Type II design. A Stepped Wedge randomized controlled trial design will be used, with a cohort of 420 adults diagnosed with depression (mild-to-moderate) who will undergo a first control phase (no treatment) followed by the intervention, which will last 16 weeks, and finishing with an optional use of the intervention. All patients will be assessed at baseline, during the treatment, and at post-treatment. The study will be conducted in three Spanish regions: Andalusia, Aragon, and the Balearic Islands. Two primary care centers of each region will participate, one located in the urban setting and the other in the rural setting. The primary outcome will be implementation success of the intervention assessing the reach, clinical effect, acceptability, appropriateness, adoption, feasibility, fidelity, penetration, implementation costs and sustainability services. Discussion: "Smiling is Fun", which has already been established as effective and cost-effective, will be adapted according to users' experiences and opinions, and the efficacy and cost-efficacy of the program will again be assessed. The study will point out barriers and facilitators to consider in the implementation process of internet-based psychological interventions in health services. The ultimate goal is to break the research-to-practice split, which would undoubtedly contribute to reduce the high burden of depression in our society. Trial registration: ClinicalTrials.gov, Identifier: NCT05294614.

Influence of Diagnostic Delay on Survival Rates for Patients with Colorectal Cancer.

Colorectal cancer affects men and women alike. Sometimes, due to clinical-pathological factors, the absence of symptoms or the failure to conduct screening tests, its diagnosis may be delayed. However, it has not been conclusively shown that such a delay, especially when attributable to the health system, affects survival. The aim of the present study is to evaluate the overall survival rate of patients with a delayed diagnosis of colorectal cancer. This observational, prospective, multicenter study was conducted at 22 public hospitals located in nine Spanish provinces. For this analysis, 1688 patients with complete information in essential variables were included. The association between diagnostic delay and overall survival at five years, stratified according to tumor location, was estimated by the Kaplan-Meier method. Hazard ratios for this association were estimated using multivariable Cox regression models. The diagnostic delay ≥ 30 days was presented in 944 patients. The presence of a diagnostic delay of more than 30 days was not associated with a worse prognosis, contrary to a delay of less than 30 days (HR: 0.76, 0.64-0.90). In the multivariate analysis, a short delay maintained its predictive value (HR: 0.80, 0.66-0.98) regardless of age, BMI, Charlson index or TNM stage. A diagnostic delay of less than 30 days is an independent factor for short survival in patients with CRC. This association may arise because the clinical management of tumors with severe clinical characteristics and with a poorer prognosis are generally conducted more quickly.

Effectiveness of eHealth-Based Psychological Interventions for Depression Treatment in Patients With Type 1 or Type 2 Diabetes Mellitus: A Systematic Review.

BACKGROUND: Comorbidity between diabetes mellitus and depression is highly prevalent. The risk of depression in a person with diabetes is approximately twice that of a person without this disease. Depression has a major impact on patient well-being and control of diabetes. However, despite the availability of effective and specific therapeutic interventions for the treatment of depression in people with diabetes, 50% of patients do not receive psychological treatment due to insufficient and difficult accessibility to psychological therapies in health systems. The use of information and communication technologies (ICTs) has therefore been proposed as a useful tool for the delivery of psychological interventions, but it continues to be a field in which scientific evidence is recent and controversial. This systematic review aims to update the available information on the efficacy of psychological interventions delivered through ICTs to improve depressive symptomatology in patients with diabetes. METHODS: A systematic review of the literature was performed following the PRISMA guidelines and using MEDLINE, Embase, PubMed, Web of Science, PsycINFO, Scopus, and Cochrane Library databases to search for randomized clinical trials of eHealth treatments for patients with diabetes and comorbid depression from 1995 through 2020. In addition, studies related to follow-up appointments were identified. Inclusion criteria were as follows: (a) randomized clinical trials (RCTs); (b) patients with type 1 and type 2 diabetes; (c) adult population over 18 years of age; (d) presence of depressive symptomatology assessed with standardized instruments; (e) treatments for depression based on established psychotherapeutic techniques and principles; (f) delivered through eHealth technologies. We did not limit severity of depressive symptomatology, delivery setting or comparison group (treatment as usual or other treatment). Two coauthors independently reviewed the publications identified for inclusion and extracted data from the included studies. A third reviewer was involved to discuss discrepancies found. The PEDro scale was used to assess the quality of the RCTs. No meta-analysis of the results was performed. The protocol used for this review is available in PROSPERO (Reg; CRD42020180405). RESULTS: The initial search identified 427 relevant scientific publications. After removing duplicates and ineligible citations, a total of 201 articles were analyzed in full text. Ten articles met the criteria of this review and were included, obtaining very good scientific quality after evaluation with the PEDro scale. The main results show that the eHealth psychological intervention for depression in patients with diabetes showed beneficial effects both at the end of treatment and in the short (3 months) and long term (6 and 12 months) for the improvement of depressive symptomatology. The methodology used (type of diabetes, eHealth technology used, recruitment context, implementation and follow-up) was very heterogeneous. However, all studies were based on cognitive-behavioral tools and used standardized assessment instruments to evaluate depressive symptomatology or diagnosis of MDD. Glycemic control was assessed by glycosylated hemoglobin, but no benefits were found in improving glycemic control. Only four studies included psychoeducational content on diabetes and depression, but none used tools to improve or enhance adherence to medical prescriptions or diabetes self-care. CONCLUSIONS: ICT-based psychological interventions for the treatment of depression in people with diabetes appear to be effective in reducing depressive symptomatology but do not appear to provide significant results with regard to glycemic control. Nonetheless, the scientific evidence reported to date is still very limited and the methodology very diverse. In addition, no studies have implemented these systems in routine clinical practice, and no studies are available on the economic analysis of these interventions. Future research should focus on studying and including new tools to ensure improvements in diabetes outcomes and not only on psychological well-being in order to advance knowledge about these treatments. Economic evaluations should also be undertaken to analyze whether these treatment programs implemented using eHealth technologies are cost-effective.

Cognitive Outcomes During COVID-19 Confinement Among Older People and Their Caregivers Using Technologies for Dementia: Protocol for an Observational Cohort Study.

BACKGROUND: The COVID-19 pandemic has led to worldwide implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine, and home confinement measures. Such restrictions on activities of daily life and separation from loved ones may lead to social isolation and loneliness with health-related consequences among community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, inadequate access to health care and social support services may aggravate chronic conditions. Home-based technological interventions have emerged for combating social isolation and loneliness, while simultaneously preventing the risk of virus exposure. OBJECTIVE: The aim of this cohort study is to explore, analyze, and determine the impact of social isolation on (1) cognition, quality of life, mood, technophilia, and perceived stress among community-dwelling older adults with mild cognitive impairment or mild dementia and on the caregiver burden; (2) access to and utilization of health and social care services; and (3) cognitive, social, and entertainment-related uses of information and communication technologies. METHODS: This study will be conducted in Málaga (Andalucía, Spain). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia and his/her informal caregiver, will be contacted by telephone. Potential respondents will be participants of the following clinical trials: support, monitoring, and reminder technology for mild dementia (n=100) and television-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (n=100). RESULTS: As of May 2021, a total of 153 participants have been enrolled and assessed during COVID-19 confinement, of whom 67 have been assessed at 6 months of enrollment. Changes in the mean values of the variables will be analyzed relative to baseline findings of previous studies with those during and after confinement, using repeated-measures analysis of variance or the nonparametric Friedman test, as appropriate. The performance of multivariate analysis of covariance (ANCOVA) to introduce potential covariates will also be considered. Values of 95% CI will be used. CONCLUSIONS: If our hypothesis is accepted, these findings will demonstrate the negative impact of social isolation owing to COVID-19 confinement on cognition, quality of life, mood, and perceived stress among community-dwelling older adults with mild cognitive impairment and mild dementia, the impact on technophilia, caregiver burden, the access to and utilization of health and social care services, and the cognitive, social, and entertainment-related use of information and communication technologies during and after COVID-19 confinement. TRIAL REGISTRATION: ClinicalTrials.gov NCT04385797; https://clinicaltrials.gov/ct2/show/NCT04385797. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26431.