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.

Evaluation of the psychometric performance of the Spanish and Catalan versions of the patient reported experiences and Outcomes of Safety in Primary Care (PREOS-PC)-Compact questionnaire.

BACKGROUND: Patients provide a unique, irreplaceable, and essential perspective in evaluating patient safety. The suite of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) tools are a notable exception to the scarcity of patient-reported patient safety measures. Full evaluation of their performance has only been attempted for the English version, thereby limiting its international applicability. OBJECTIVES: To assess the psychometric performance of the Spanish and Catalan versions of the PREOS-PC-Compact. METHODS: Cross-sectional validation study. We used Classical Test Theory methods to examine scale score distribution, internal consistency, and construct validity; and Item Response Theory (IRT) methods to further explore construct validity. RESULTS: 3287 patients completed the Spanish version, and 1007 the Catalan version. Similar results were obtained for both versions. Confirmatory Factor Analysis supported a single construct for each scale. The correlations between PREOS-PC-Compact scales and known group analysis suggested adequate construct validity (inconclusive for known groups at the provider level). All four multi-item scales demonstrated adequate internal consistency reliability (α > 0.7), which was only confirmed for test-retest reliability for 'Practice activation.' A sample between 60-90 patients per practice was estimated sufficient to produce scores with reliability > 0.7 for all scales except for harm scales. IRT models showed disordered thresholds for 'Practice activation' and 'Harm burden' but showed excellent fit after reducing the response categories. CONCLUSION: The Spanish and Catalan versions of the PREOS-PC-Compact are broadly valid and reliable tools to measure patient safety in Spanish primary care centres; confirmation of lower-than-expected test-rest reliability merits further examination .

One-year follow-up of the effectiveness of a lifestyle modification programme as an adjuvant treatment of depression in primary care: A randomised clinical trial.

BACKGROUND: An estimated 280 million individuals suffer from depression. Brief group interventions in Primary Healthcare Centres (PHCs) are recommended. One goal of these interventions is to educate people about healthy lifestyle habits, as they prevent the development of depression. This study aims to analyse the one-year follow-up results about the effectiveness of a Lifestyle Modification Programme (LMP) and an LMP plus Information and Communication Technologies (LMP + ICTs) when compared to Treatment as Usual (TAU). METHODS: We conducted an open-label, multicentre, pragmatic, randomised clinical trial. A total of 188 individuals that visited a general practitioner and met the inclusion criteria were randomised. LMP consisted of six weekly 90-minute group sessions focusing on lifestyle improvement. LMP + ICTs was a hybrid of the LMP format with the inclusion of a wearable smartwatch. We used linear mixed models (with a random intercept and an unstructured covariance) to evaluate the effectiveness of the interventions, and an intention-to-treat analysis and Multiple Imputation technique for handling missing data. RESULTS: LMP + ICTs showed a statistically significant reduction on depressive symptoms (b = -2.68, 95 % CI = [-4.239, -1.133] p = .001) and sedentarism (b = -37.38, 95 % CI [-62.930, -11.833], p = .004) compared to TAU. LIMITATIONS: Most of the dropouts were due to time restrictions. CONCLUSIONS: In long-term, LMPs plus ICTs administered in PHCs to people suffering from depression were effective in reducing depressive symptomatology and sedentarism comparing to TAU. More research is needed to enhance adherence to lifestyle recommendations. These promising programmes could be easily implemented in PHCs. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03951350).

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.

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.

Utility of PHQ-2, PHQ-8 and PHQ-9 for detecting major depression in primary health care: a validation study in Spain.

BACKGROUND: Primary health care (PHC) professionals may play a crucial role in improving early diagnosis of depressive disorders. However, only 50% of cases are detected in PHC. The most widely used screening instrument for major depression is the Patient Health Questionnaire (PHQ), including the two-, eight- and nine-item versions. Surprisingly, there is neither enough evidence about the validity of PHQ in PHC patients in Spain nor indications about how to interpret the total scores. This study aimed to gather validity evidence to support the use of the three PHQ versions to screen for major depression in PHC in Spain. Additionally, the present study provided information for helping professionals to choose the best PHQ version according to the context. METHODS: The sample was composed of 2579 participants from 22 Spanish PHC centers participating in the EIRA-3 study. The reliability and validity of the three PHQ versions for Spanish PHC patients were assessed based on responses to the questionnaire. RESULTS: The PHQ-8 and PHQ-9 showed high internal consistency. The results obtained confirm the theoretically expected relationship between PHQ results and anxiety, social support and health-related QoL. A single-factor solution was confirmed. Regarding to the level of agreement with the CIDI interview (used as the criterion), our results indicate that the PHQ has a good discrimination power. The optimal cut-off values were: ⩾2 for PHQ-2, ⩾7 for PHQ-8 and ⩾8 for PHQ-9. CONCLUSIONS: PHQ is a good and valuable tool for detecting major depression in PHC patients in Spain.

Effectiveness of a lifestyle modification programme in the treatment of depression symptoms in primary care.

Background: Depression symptoms are prevalent in the general population, and their onset and continuation may be related to biological and psychosocial factors, many of which are related to lifestyle aspects. Health promotion and lifestyle modification programmes (LMPs) may be effective on reducing the symptoms. The objective of this study was to analyse the clinical effectiveness of a LMP and a LMP plus Information and Communication Technologies, when compared to Treatment as Usual (TAU) over 6 months. The interventions were offered as an adjuvant treatment delivered in Primary Healthcare Centers (PHCs) for people with depression symptoms. Methods: We conducted an open-label, multicentre, pragmatic, randomized clinical trial. Participants were recruited from several PHCs. Those participants visiting general practitioner for any reason, who also met the inclusion criteria (scoring 10 to 30 points on the Beck II Self-Applied Depression Inventory) were invited to take part in the study. TAU+LMP consisted of six weekly 90-min group sessions focused on improving lifestyle. TAU+LMP + ICTs replicated the TAU+LMP format, plus the addition of a wearable smartwatch to measure daily minutes walked and sleep patterns. A total of 188 participants consented to participate in the study and were randomized. We used linear mixed models, with a random intercept and an unstructured covariance to evaluate the impact of the interventions compared to TAU. Results: Both interventions showed a statistically significant reduction on depressive symptoms compared to TAU (TAU+LMP vs. TAU slope difference, b = -3.38, 95% CI= [-5.286, -1.474] p = 0.001 and TAU+LMP+ICTs vs. TAU slope difference, b = -4.05, 95% CI = [-5.919, -2.197], p < 0.001). These reductions imply a moderate effect size. In the TAU+LMP+ICTs there was a significant increase regarding minutes walking per week (b = 99.77) and adherence to Mediterranean diet (b = 0.702). In the TAU+LMP there was a significant decrease regarding bad sleep quality (b = -1.24). Conclusion: TAU+LMPs administered in PHCs to people experiencing depression symptoms were effective on reducing these symptoms compared to TAU. They also have a positive impact on changing several lifestyle factors. These findings indicate that these interventions can be promising strategies for PHCs.

Associations Between Severity of Depression, Lifestyle Patterns, and Personal Factors Related to Health Behavior: Secondary Data Analysis From a Randomized Controlled Trial.

Background: Depression is a prevalent condition that has a significant impact on psychosocial functioning and quality of life. The onset and persistence of depression have been linked to a variety of biological and psychosocial variables. Many of these variables are associated with specific lifestyle characteristics, such as physical activity, diet, and sleep patterns. Some psychosocial determinants have an impact on people' health-related behavior change. These include personal factors such as sense of coherence, patient activation, health literacy, self-efficacy, and procrastination. This study aims to analyze the association between the severity of depression, lifestyle patterns, and personal factors related to health behavior. It also aims to analyze whether personal factors moderate the relationship between lifestyles and depression. Methods: This study is a secondary data analysis (SDA) of baseline data collected at the start of a randomized controlled trial (RCT). A sample of 226 patients with subclinical, mild, or moderate depression from primary healthcare centers in two sites in Spain (Zaragoza and Mallorca) was used, and descriptive, bivariate, multivariate, and moderation analyses were performed. Depression was the primary outcome, measured by Beck II Self-Applied Depression Inventory. Lifestyle variables such as physical exercise, adherence to Mediterranean diet and sleep quality, social support, and personal factors such as self-efficacy, patient activation in their own health, sense of coherence, health literacy, and procrastination were considered secondary outcomes. Results: Low sense of coherence (ß = -0.172; p < 0.001), poor sleep quality (ß = 0.179; p = 0.008), low patient activation (ß = -0.119; p = 0.019), and sedentarism (more minutes seated per day; ß = 0.003; p = 0.025) are predictors of having more depressive symptoms. Moderation analyses were not significant. Discussion: Lifestyle and personal factors are related to depressive symptomatology. Our findings reveal that sense of coherence, patient's activation level, sedentarism, and sleep quality are associated with depression. Further research is needed regarding adherence to Mediterranean diet, minutes walking per week and the interrelationship between lifestyles, personal factors, and depression.

Feasibility of the SINERGIAPS ("Sinergias entre profesionales y pacientes para una Atención Primaria Segura") intervention for improving patient safety in primary care.

AIM: The primary aim was to examine the feasibility of intervention delivery and of trial procedures. Secondary aims were to study the intervention uptake; its acceptability and perceived utility; and its potential to improve safety culture and avoidable hospital admissions. METHODS: We conducted a 3-month, single-arm feasibility study in 10 primary care (PC) centres in Spain. Centres received information regarding patients' experiences of safety (through the Patient Reported Experiences and Outcomes of Safety in Primary Care [PREOS-PC] questionnaire), and were instructed to plan safety improvements based on that feedback. We used a bespoke online tool to recruit PC professionals, collect patient feedback, and deliver it to the centres, and to collect outcome data (patient safety culture [Medical Office Survey on Patient Safety Culture, MOSPSC questionnaire]). We measured recruitment and follow-up rates and intervention uptake (based on the number of safety improvement plans registered). We conducted semistructured interviews with 9 professionals to explore the intervention acceptability and perceived utility. RESULTS: Of 256 professionals invited, 120 (47%) agreed to participate, and 97 completed baseline and postintervention measures. Of 780 patients invited, 585 (75%) completed the PREOS-PC questionnaire. Five of 10 centres (50%) designed an improvement plan, providing 27 plans in total (range per centre, 1-14). The intervention was perceived as a novel strategy for improving safety, although the healthcare professionals identified several factors limiting its acceptability and utility: lack of feedback at the individual professional level; potentially unrepresentative sample of patients providing feedback; and number of educational materials deemed overwhelming. DISCUSSION: It is feasible to deliver the proposed intervention so long as the identified limitations are addressed.

Cross-Cultural Adaptation, Validation, and Piloting of the Patient Reported Experiences and Outcomes of Safety in Primary Care Questionnaire for Its Use in Spain.

OBJECTIVE: This study aimed to cross-culturally adapt, validate, and pilot the Patient Reported Experiences and Outcomes of Safety in Primary Care questionnaire for its use in Spain. METHODS: After setting up an expert panel to determine its content validity, the questionnaire was translated and back-translated, and subjected to cognitive testing. The questionnaire was piloted in a cross-sectional study in 10 primary health care centers in Spain. Fifty patients per center completed the questionnaire while waiting for an appointment. We estimated (i) the acceptability of the questionnaire (response rate), (ii) scores distribution (floor and ceiling effects), (iii) internal consistency (Cronbach α), and (iv) construct validity (exploratory factor analyses and correlation between scales). To examine patients' evaluations of patient safety, we followed a mixed-methods approach: (i) statistical analyses at the scale and item levels based on responses to standardized items and (ii) qualitative content analysis based on responses to open-ended questions. RESULTS: Complete data were collected from 493 patients (participation rate, 77%). A ceiling effect was observed for 3 scales ("safety problems," "harm severity," "harm needs"). The internal consistency was adequate (α > 0.7) for the majority of scales. Exploratory factor analysis and correlation between scales suggested an appropriate construct validity. Two hundred twenty-six (45.8%) respondents experienced at least 1 safety problem, and 109 (23.2%) reported harm in the previous 12 months. CONCLUSIONS: The multidimensional primary health care patient safety instrument Patient Reported Experiences and Outcomes of Safety in Primary Care is now available for its use in Spain. Initial testing demonstrates its potential for use in primary care. Future developments will further address its use in actual clinical practice.

Impact of Smartphone App-Based Psychological Interventions for Reducing Depressive Symptoms in People With Depression: Systematic Literature Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND: Depression is a serious, disabling mental disorder that severely affects quality of life. Patients with depression often do not receive adequate treatment. App-based psychotherapy is considered to have great potential to treat depression owing to its reach and easy accessibility. OBJECTIVE: We aim to analyze the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. METHODS: We conducted a systematic literature review and meta-analysis. We searched Medline, Embase, PsycINFO, Web of Science, and Cochrane Central Register of Controlled Trials from inception to December 23, 2020. We selected randomized controlled trials to examine the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Study selection, data extraction, and critical appraisal (using the Cochrane Risk of Bias tool for randomized studies and the ROBINS-I tool for nonrandomized studies) were conducted independently by 2 reviewers. Where possible, we pooled data using random effects meta-analyses to obtain estimates of the effect size of the intervention. We conducted post hoc meta-regression analyses to explore the factors associated with intervention success. RESULTS: After screening 3468 unique references retrieved from bibliographic searches and assessing the eligibility of 79 full texts, we identified 12 trials (2859 participants) evaluating 14 different interventions. Of 14 trials, 7 (58%) were conducted in the United States; 3 (25%) trials, in Asia (Japan, South Korea, and China); 1 (8%) trial, in Australia; and 1 (8%) trial, in Germany. Of the 12 trials, 5 (42%) trials presented a low risk of bias. The mean duration of the interventions was 6.6 (SD 2.8) weeks. Two-thirds of the interventions were based on cognitive behavioral therapy alone or included it in combination with cognitive control therapy, positive psychology, brief behavioral activation, or mindfulness- and acceptance-based therapy. With no evidence of publication bias, a pooled analysis of 83% (10/12) of the trials and 86% (12/14) of the interventions showed that app-based interventions, compared with a control group receiving usual care or minimal intervention, produced a moderate reduction in depressive symptoms (standardized mean difference [SMD] -0.51, 95% CI -0.69 to -0.33; 2018/2859, 70.58% of the participants; I2=70%). Our meta-regression analyses indicated that there was a greater reduction in symptoms of depression (P=.04) in trials that included participants with moderate to severe depression (SMD -0.67, 95% CI -0.79 to -0.55), compared with trials with participants exhibiting mild to moderate depression (SMD -0.15, 95% CI -0.43 to -0.12). CONCLUSIONS: App-based interventions targeted at people with depression produce moderate reductions in the symptoms of depression. More methodologically robust trials are needed to confirm our findings, determine which intervention features are associated with greater improvements, and identify those populations most likely to benefit from this type of intervention. TRIAL REGISTRATION: PROSPERO CRD42019145689; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=145689.

Insomnia and sleep quality in healthcare workers fighting against COVID-19: a systematic review of the literature and meta-analysis.

The COVID-19 pandemic has the potential to significant- ly affect the mental health of healthcare workers, who stand in the frontline of this crisis. Insomnia is often related to exposure to stressful situations, such as the current health crisis, as well as other mental disorders, physical conditions and work-related problems. The objectives of this systematic review were: 1) to examine the impact of the current health pandemic produced by COVID-19 on insomnia and sleep quality of health professionals, and 2) to identify risk factors associated with insomnia. After a literature search in MEDLINE, EMBASE, and PsycINFO, 18 relevant studies were identified. The prevalence of insomnia estimated by random effects meta-analysis was 38% (95%CI= 37 to 39%), being slightly higher in women (29%, 95%CI= 27% to 30%) than in men (24%, 95%CI= 21 to 27%). The main risk factor associated with insomnia was working in a high-risk environment, followed by female sex and having a lower educational level. The high figures of self-reported insomnia and poor sleep quality observed indicate the need to develop interventions aimed at mitigating and caring for the mental health of healthcare workers fighting against this pandemic.

Insomnio y calidad del sueño en profesionales sanitarios frente a la Covid-19: una revisión sistemática de la literatura y meta-análisis / Children’s adverse experiences and psychotic chronification

La pandemia de COVID-19 tiene el potencial de afectarsignificativamente la salud mental de los profesionales sanitarios que se encuentran en la primera línea de esta crisis.El insomnio está relacionado con la exposición a situacionesestresantes, como la actual, así como con otros trastornosmentales, patologías físicas y problemas laborales. Los objetivos de esta revisión sistemática fueron: 1) examinar el impacto de la actual pandemia sanitaria producida por COVID-19en el insomnio y la calidad del sueño de los profesionalessanitarios, y 2) identificar los factores de riesgo asociados alinsomnio. Tras una búsqueda bibliográfica en MEDLINE, EMBASE y PsycInfo se identificaron 18 estudios relevantes. Laprevalencia de insomnio autoinformado estimada mediantemeta-análisis de efectos aleatorios fue del 38 % (IC95 %: 37a 39 %), siendo ligeramente superior en mujeres (29 %, IC95%: 27 a 30 %) que en hombres (24 %, IC95 %: 21 a 27 %). Elprincipal factor de riesgo asociado al insomnio fue trabajaren un entorno de alto riesgo, seguido del género femenino yun menor nivel educativo. Las cifras de insomnio y la calidaddel sueño observadas indican la necesidad de desarrollar intervenciones destinadas a mitigar y cuidar la salud mental de los sanitarios al frente de esta pandemia. (AU)

COVID-19 pandemic has the potential to significantlyaffect the mental health of healthcare workers, who standin the frontline of this crisis. Insomnia is often related toexposure to stressful situations, such as the current healthcrisis, as well as other mental disorders, physical conditionsand work-related problems. The objectives of this systematicreview were: 1) to examine the impact of the current health pandemic produced by COVID-19 on insomnia and sleepquality of health professionals, and 2) to identify risk factors associated with insomnia. After a literature search inMEDLINE, EMBASE, and PsycInfo, 18 relevant studies wereidentified. The prevalence of insomnia estimated by randomeffects meta-analysis was 38 % (95 % CI: 37 to 39 %), being slightly higher in women (29 %, 95 % CI: 27 % to 30%) than in men (24 %, 95 % CI: 21 to 27 %). The main riskfactor associated with insomnia was working in a high-riskenvironment, followed by female sex and having a lowereducational level. The figures of self-reported insomnia andworse quality of sleep observed indicate the need to developinterventions aimed at mitigating and caring for the mentalhealth of healthcare workers fighting against this pandemic. (AU)

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.

Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol.

INTRODUCTION: Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions. OBJECTIVE: The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD. METHODS: This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire. DISCUSSION: Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures. CLINICALTRIALS REGISTRATION NUMBER: NCT04428099.

Impact of viral epidemic outbreaks on mental health of healthcare workers: a rapid systematic review and meta-analysis.

BACKGROUND: This study aimed at examining the impact of providing healthcare during health emergencies caused by viral epidemic outbreaks on healthcare workers' (HCWs) mental health; to identify factors associated with worse impact, and; to assess the available evidence base regarding interventions to reduce such impact. METHOD: Rapid systematic review. We searched MEDLINE, Embase, and PsycINFO (inception to August 2020). We pooled data using random-effects meta-analyses to estimate the prevalence of specific mental health problems, and used GRADE to ascertain the certainty of evidence. RESULTS: We included 117 studies. The pooled prevalence was higher for acute stress disorder (40% (95%CI 39 to 41%)), followed by anxiety (30%, (30 to 31%)), burnout (28% (26 to 31%)), depression (24% (24 to 25%)), and post-traumatic stress disorder (13% (13 to 14%)). We identified factors associated with the likelihood of developing those problems, including sociodemographic (younger age and female gender), social (lack of social support, stigmatization), and occupational (working in a high-risk environment, specific occupational roles, and lower levels of specialised training and job experience) factors. Four studies reported interventions for frontline HCW: two educational interventions increased confidence in pandemic self-efficacy and in interpersonal problems solving (very low certainty), whereas one multifaceted intervention improved anxiety, depression, and sleep quality (very low certainty). LIMITATIONS: We only searched three databases, and the initial screening was undertaken by a single reviewer. CONCLUSION: Given the very limited evidence regarding the impact of interventions to tackle mental health problems in HCWs, the risk factors identified represent important targets for future interventions.

Exploring primary health care professionals' perceptions about a patient feedback intervention to improve patient safety in Spanish primary health care centres: a qualitative study.

BACKGROUND: Patient feedback interventions are receiving increasing attention given their potential to improve health care provision. However, primary health care (PHC) professionals' acceptability and perceived utility of this type of interventions remain largely unexplored. OBJECTIVES: The aim of this study was to explore PHC professionals' perceptions, opinions and suggestions about a patient feedback intervention currently being designed to improve patient safety in Spanish PHC centres. METHODS: We conducted an exploratory qualitative study with 43 PHC professionals. Information was obtained from three semi-structured interviews and four focus groups. All data were audio-recorded, transcribed and analyzed using content analysis by three analysts. RESULTS: The patient feedback intervention was acceptable to health care professionals, who perceived it as a useful strategy to improve health care processes and activate patients. A number of factors potentially limiting the acceptability and perceived utility of the intervention were identified (low patient safety culture, low patient-centred care orientation and limited credibility of patient feedback data). Recommendations for designing and implementing the proposed intervention in the Spanish PHC centres were identified in relation to the following areas: 'collection and analysis of feedback data'; 'feedback display'; 'feedback delivery' and; 'implementation of safety improvement initiatives'. CONCLUSIONS: Although the proposed intervention was generally perceived as useful and acceptable, our study identified a number of tensions about the practical aspects of using the patient-reported data and the credibility of the data and what actions would arise from its use. The intervention has been adapted to address these tensions before its formal evaluation in a randomized clinical trial.

Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol.

INTRODUCTION: Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres. METHODS AND ANALYSIS: The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences. TRIAL REGISTRATION NUMBER: NCT03837912; pre-results.