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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 .

Introduction: Insomnia is the most common sleep disorder, and it adversely impacts daily living and increases the risk of chronic and acute health problems. Of the few individuals who seek treatment for insomnia, most pursue help in primary care settings. The management of insomnia most commonly focuses on the prescription of hypnotics and sleep hygiene recommendations, although these are not the most effective treatments. Conversely, cognitive-behavioural therapy for insomnia (CBT-i), which is considered to be the first-line treatment for persistent insomnia, is seldom prescribed by primary care physicians (PCPs) or primary care nurses (PCNs). The hesitancy of these professionals to provide CBT-i is mainly attributed to their heavy workloads and the difficulties in acquiring the skills needed to administer this intervention., Methods and Analysis: A two-arm cluster-randomised study (in which patients are assigned to a PCP or PCN) will be conducted in primary health centres of Majorca Island (Spain). A total of 206 patients will be recruited. Healthcare professionals will be allocated to the intervention or control group in a 1:1 ratio. The intervention group will receive CBT-i and the control group will receive usual care. We will include patients with Insomnia Severity Index scores of 8 or more who also report that insomnia interferes with daily functioning or is noticeable to others. The CBT-i will consist of four individual structured sessions, three in person (20 min each) and one by telephone (10 min) that are administered at intervals of 2-3 weeks. An additional session will be provided for patients taking hypnotic medications. The primary outcome measure is the decrease in sleep latency, which will be measured with the Pittsburg Sleep Quality index at 6 months and 12 months., Ethics and Dissemination: This project was approved by the Ethical Committee of the Balearic Islands (IB 4604/21 PI) and the Primary Care Research Committee of the Department of Majorca Primary Care (PI19/24). All participants are required to provide written informed consent and no study-related procedures will be performed until consent is obtained. The trial results will be published in peer-reviewed journals and presented at conferences., Trial Registration Number: ISRCTN10144646., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Fiol-deRoque, Serrano-Ripoll, Mira-Martínez, Pastor-Moreno, Sitges, García-Buades, Gervilla, Garcia-Toro, Zamanillo-Campos and Ricci-Cabello.)

Background: Spain's lockdown measures couldn't prevent the severe impact of the COVID-19 first wave, leading to high infections, deaths, and strain on healthcare workers (HCWs). This study aimed to explore the mental health impact on HCWs in the Balearic Islands during the initial months of the pandemic, the influencing factors, and the experiences of those in a COVID-19 environment., Methods: Using a mixed-methods approach, the study encompassed quantitative and qualitative elements. Cross-sectional survey data from April to June 2020 comprised HCWs who were emailed invitations. The survey covered demographics, work, clinical and COVID-19 variables, along with psychological distress and PTSD symptoms, using validated measures. Additionally, semi-structured interviews with HCWs offered qualitative insights., Results: Three hundred thirty-six HCWs averaging 46.8 years, mainly women (79.2%), primarily nurses in primary care with over 10 years of experience. Anxiety symptoms were reported by 28.8%, 65.1% noted worsened sleep quality, and 27.7% increased psychoactive drug usage. Psychological distress affected 55.2%, while 27.9% exhibited PTSD symptoms. Gender, age, experience, COVID-19 patient contact, and workload correlated with distress, PTSD symptoms, sleep quality, and psychoactive drug usage. Interviews uncovered discomfort sources, such as fear of infection and lack of control, leading to coping strategies like information avoidance and seeking support., Limitations: Static cross-sectional design, non-probabilistic sample, and telephone interviews affecting non-verbal cues, with interviews conducted during early pandemic lockdown., Conclusions: HCWs faced significant psychological distress during the pandemic's first wave, underscoring the necessity for robust support and resources to counteract its impact on mental health., (© 2024. The Author(s).)

Background: Despite the increasing interest in text-messaging interventions to support healthcare delivery, the available evidence about their effectiveness is still limited., Objectives: 1) to develop DiabeText, an intervention delivering automated, tailored brief text messages to support diabetes self-management; 2) to explore the potential impact of DiabeText on self-management behavior and glycaemic control, and; 3) to examine the feasibility of conducting a future phase III randomized clinical trial to evaluate the effectiveness of DiabeText., Methods: 3-month, two-arm, randomized feasibility trial (ClinicalTrials.gov: NCT04738591) with patients with type 2 diabetes (HbA1c > 8%). Participants were allocated to the control (usual care) or DiabeText group (usual care + five text messages per week). Outcomes were: recruitment rate; follow-up rate, missing data; medication adherence; adherence to Mediterranean diet; physical activity; and HbA1c. In addition, after delivering the intervention, we conducted a qualitative study involving 14 semi-structured interviews with participants allocated to the DiabeText group, to understand their views about the intervention., Results: From 444 screened people, we recruited 207 participants (recruitment rate = 47%), of which 179 completed the post-intervention interview (follow-up rate = 86%). We sent 7,355 SMS during the intervention period, of which 99% successfully reached the participants. At post-intervention, DiabeText was associated with non-statistically significant (p > 0.05) improvements in adherence to medication (OR = 2.0; 95%CI 1.0 to 4.2), Mediterranean diet (1.7; 0.9 to 3.2), and physical activity (1.7; 0.9 to 3.1). No between-group differences were observed in mean HbA1c (p = 0.670). The qualitative study indicated that participants perceived DiabeText as a helpful resource because it increased their awareness about the importance of adequate self-management and the sense of being cared for., Conclusions: DiabeText is the first system in Spain to integrate patient-generated and routinely collected clinical data to deliver tailored text messages to support diabetes self-management. More robust trials are needed to determine its effectiveness and cost-efficacy., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer JH declared a shared affiliation with the authors AA-L, BO-B, and JG-C to the handling editor at the time of review., (Copyright © 2023 Garcia-Toro, Aguilar-Latorre, Garcia, Navarro-Guzmán, Gervilla, Seguí, Gazquez, Marino, Gomez-Juanes, Serrano-Ripoll, Oliván-Blázquez, Garcia-Campayo, Maloney and Montero-Marin.)

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.

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., (© The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Aguilar-Latorre, Pérez Algorta, Navarro-Guzmán, Serrano-Ripoll and Oliván-Blázquez.)

Background: Antidiabetic medication is effective in preventing diabetes-related complications. However, 40% of type 2 diabetic patients do not adhere to their medication regimes adequately. Brief text messages represent a promising approach to support medication adherence. The aim of this study was to explore the perspectives of primary care professionals (PCPs) concerning the DiabeText intervention, a new text messaging intervention to be developed to support medication adherence in people with type 2 diabetes (T2D) in Mallorca, Spain., Methods: We conducted four focus groups ( n = 28) and eight semi-structured interviews with doctors and nurses. Data collection and analysis were carried out by researchers independently following Braun and Clark's methodology., Results: Three main themes were identified: (1) text messaging interventions have the potential to effectively support diabetes self-management; (2) involving PCPs in the intervention would facilitate its design and implementation; (3) obtaining evidence supporting the cost-effectiveness is a key prerequisite for large-scale implementation of the intervention. PCPs identified barriers and enablers of the design and implementation of the intervention and made suggestions about the content and format of the text messages., Conclusion: The DiabeText intervention is perceived as useful and acceptable by PCPs provided its cost-effectiveness.

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 ( β  = -0.172; p  < 0.001), poor sleep quality ( β  = 0.179; p  = 0.008), low patient activation ( β  = -0.119; p  = 0.019), and sedentarism (more minutes seated per day; β  = 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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Aguilar-Latorre, Serrano-Ripoll, Oliván-Blázquez, Gervilla and Navarro.)

Background: Type 2 Diabetes Mellitus (T2DM) is a long-term condition affecting around 10% of people worldwide. This study aimed to explore T2DM patients' views on DiabeText, a new text messaging intervention to be developed to support adherence to diabetes medication., Methods: A total of four focus groups were conducted with a purposive sample of people with T2DM (n = 34). The data were analysed by multiple researchers independently, and coded using thematic analysis., Results: There were two main themes that emerged: (1) "patients' perspectives on unmet needs for diabetes self-management", and (2) "acceptability and perceived utility of DiabeText". The patients identified a number of barriers for diabetes self-management, including lack of appropriate information and support with diet and physical activity. Support for medication-taking was not perceived as urgently needed, although several barriers were identified (eating outside, traveling, polymedication, dispensation at the pharmacy). The participants anticipated that the proposed intervention would present high levels of patient acceptability and perceived utility as long as its content addresses the barriers that were identified, and includes specific features (short and clear messages, and personalized information)., Conclusion: The proposed intervention has the potential to be well accepted and perceived as useful by T2DM patients who require support not only in terms of medication-taking, but more prominently of lifestyle behaviour.

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; I 2 =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&#95;record.php?RecordID=145689., (©Maria J Serrano-Ripoll, Rocío Zamanillo-Campos, Maria A Fiol-DeRoque, Adoración Castro, Ignacio Ricci-Cabello. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 27.01.2022.)

Confining the entire population to a lockdown after the outbreak of SARS-CoV-2 was an unprecedented measure designed to protect the health of those living in Spain. The objective of the present study is to assess the evolution of mental health and psychological wellbeing during lockdown. To do this, we carried out a longitudinal study, via an online survey over the eight weeks of lockdown (weekly assessments). Sociodemographic variables were recorded, along with data related to COVID-19, psychological wellbeing (anxiety, depression, psychotropic drugs, consultations made to improve mood or anxiety), life satisfaction, and self-perceived health. A total of 681 individuals participated in the study, 76.8% were women; the mean age was 43 years old (SD = 12.7). Initially, high scores were reported for anxiety, depression, and the number of consultations to improve mood, but these decreased significantly over the study period. The reverse seems to be true for life satisfaction, perceived good health, and intake of psychotropic drugs. We also identified groups whose psychological wellbeing was more susceptible to the effects of lockdown. Women, those worried about their jobs after the pandemic, and those afraid of being infected were the most affected individuals. More generally, after the initial negative effect on psychological wellbeing, various indicators improved over the lockdown period.

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.

Background: The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context., Objective: The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic., Methods: We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation., Results: Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference -0.04; 95% CI -0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (-0.29; 95% CI -0.48 to -0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (-0.25; 95% CI -0.49 to -0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability., Conclusions: In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications., Trial Registration: ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818., (©Maria Antònia Fiol-DeRoque, Maria Jesús Serrano-Ripoll, Rafael Jiménez, Rocío Zamanillo-Campos, Aina María Yáñez-Juan, Miquel Bennasar-Veny, Alfonso Leiva, Elena Gervilla, M Esther García-Buades, Mauro García-Toro, Pablo Alonso-Coello, Guadalupe Pastor-Moreno, Isabel Ruiz-Pérez, Carolina Sitges, Javier García-Campayo, Joan Llobera-Cánaves, Ignacio Ricci-Cabello. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 18.05.2021.)

Introduction: Major depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programmes (LMPs), taking into account personal factors and facilitators. The main objective of this protocol is to analyse the clinical effectiveness, cost-effectiveness and cost utility of an LMP and an LMP with information and communication technologies (ICTs) as adjunctive treatment for depression in primary care patients. The secondary objectives are to analyse the clinical effectiveness in the subgroup that presents comorbidity and to analyse the correlation between personal factors on health behaviour and lifestyle patterns., Methods and Analysis: A randomised, multicenter pragmatic clinical trial with three parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: (1) Usual antidepressant treatment with psychological advice and/or psychotropic drugs prescribed by the general practitioner (treatment as usual (TAU)). (2) TAU+LMP. A programme to be imparted in six weekly 90-minute group sessions, intended to improve the following aspects: behavioural activation+daily physical activity+adherence to the Mediterranean diet pattern+sleep hygiene+careful exposure to sunlight. (3) TAU+LMP+ICTs: healthy lifestyle recommendations (TAU+LMP)+monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal factors on health behaviour, social support, lifestyle patterns and chronic comorbid pathology. Data will be collected before and after the intervention, with 6-month and 12-month follow-ups., Ethics and Dissemination: This study has been approved by the Clinical Research Ethics Committee of Aragón (approval number: C.P.-C.I. PI18/286) and the Research Ethics Committee of the Balearic Islands (IB3950/19 PI). Data distribution will be anonymous. Results will be disseminated via conferences and papers published in peer-reviewed, open-access journals., Trial Registration Number: ClinicalTrials.gov Registry (NCT03951350)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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.

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., Competing Interests: Competing interests: IR-C and JMV co-developed the PREOS-PC questionnaire, which is now being licensed by Oxford Innovation Ltd., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Major depression is a highly prevalent condition. Its pathogenesis is related to a wide variety of biological and psychosocial factors and among these is factors related to lifestyle. Lifestyle-based interventions seem to be appropriate strategies as coadjutant treatment. The objective of this study is to explore and identify expectations and experiences of both patients and healthcare professionals that can point to the main barriers and facilitators with regard to the promotion of healthy dietary and hygiene behaviours in patients suffering from major depression., Methods: A qualitative design was used to collect information from a wide range of purposefully and theoretically guided samples of depressed patients and health professionals from Primary Care (PC). Both in-depth interviews and discussion groups were used. A standardized protocol was designed to guide the interviews and groups, including the preparation of a topic list to be addressed, with previously tested, open suggestions that could be of interest. A thematic analysis was performed from grounded theory in order to explore, develop and define until saturation the emergent categories of analysis derived from the individual interview and group data., Results: Both patients as well as PC professionals noted a series of central aspects with respect to the implementation of a programme for the acquisition of healthy dietary and hygiene habits for depressive patients, which may be organized around 'personal', 'programmatic', and 'transversal' aspects. As for the personal aspects, categories regarding 'patient history', and 'disposition' were found; the programmatic aspects included categories such as 'presentation and monitoring', and modification of 'cognitive' and 'behavioural' habits; whereas the transversal aspects comprised the possibilities of 'social support' and defining categories of 'objectives'., Conclusion: The implementation of intervention programmes that combine dietary and hygiene-related factors in patients with depression is complex, given the nature of the disorder itself, and its symptoms such as apathy and feelings of guilt or incompetence. Key issues exist for the success of the intervention, such as the simplicity of guidelines, tailoring through motivational interviewing, prolonged and intense monitoring throughout the different stages of the disorder, and the provision of adequate feedback and social support. PC could be an appropriate level in which to implement these interventions.