Maria Jesús Serrano-Ripoll

BACKGROUND Suicide is a major public health concern, and primary care has an important role in detecting and intervening in at-risk cases. However, many primary healthcare workers claim to feel inadequately prepared when it comes to properly identifying, preventing, and handling suicidal behaviour in clinical practice. OBJECTIVE The objective of this study is to develop and evaluate an intervention for improving primary healthcare workers ability to identify, prevent, and handle suicidal behaviour. METHODS This protocol describes the PROMESA study, which uses a multimethod design in four sequential phases, in line with some of the phases laid out in the Medical Research Council framework for developing and evaluating complex interventions. In phase 1, a qualitative study will be performed using four focus groups and at least 20 semi-structured interviews with primary healthcare professionals, people with lived experience, and bereaved family members, via a thematic analysis. Phase 2 will involve a retrospective case-control study covering the period 2019-2023. The analysis will focus on sociodemographic and clinical factors as well as patterns of use of healthcare services utilization among individuals who showed suicidal behaviour. Data will be obtained from Electronic Health Records to identify cases and matched controls, enabling the assessment of associations between these factors and suicidal behaviour. Two interventions will be designed for phase 3: (1) the specific training and delivery of a report with the results of the study from phase 2 to PC HCWs, and (2) the same intervention plus the inclusion of a tool in which patients self-evaluate their risk of suicide. Phase 4 will consist of a controlled, phase II, single-blind, randomized clinical trial with three parallel arms (intervention 1, intervention 2, and a control group), which will assess the feasibility and effectiveness of these interventions including 126 primary healthcare workers. RESULTS The study was funded in 2024, March. Recruitment of health care professionals is currently ongoing. The study findings will be reported in future publications. CONCLUSIONS The epidemiological trends and documented gaps in primary care preparedness highlight the need for strengthened strategies in the early detection and management of suicidal behaviour. This study is expected to provide essential insights into the feasibility and acceptability of implementing tailored training and decision‑support tools for primary healthcare workers. By combining qualitative perspectives, epidemiological evidence, and a controlled feasibility trial, the project will help determine whether the interventions can be integrated into routine practice and whether they show promise for improving clinical response to suicidal behaviour. The findings will inform the refinement of the intervention and guide the development of a future full‑scale evaluation aimed at advancing suicide prevention efforts in primary care. CLINICALTRIAL Registration number ISRCTN8134762 on 25/04/2025.

Background: The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. Objective: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA1c) and in improving secondary clinical, physiological, and behavioral outcomes. Methods: We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA1c levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. Results: In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA1c levels compared to the control group (β=−0.05, 95% CI −0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=−0.04, 95% CI −0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention’s dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. Conclusions: While PREDIABETEXT did not significantly improve HbA1c levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. Trial Registration: ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625 International Registered Report Identifier (IRRID): RR2-10.3390/ijerph192214706

BACKGROUND The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. OBJECTIVE This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA1c) and in improving secondary clinical, physiological, and behavioral outcomes. METHODS We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA1c levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. RESULTS In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA1c levels compared to the control group (β=−0.05, 95% CI −0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=−0.04, 95% CI −0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention’s dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. CONCLUSIONS While PREDIABETEXT did not significantly improve HbA1c levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. CLINICALTRIAL ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625 INTERNATIONAL REGISTERED REPORT RR2-10.3390/ijerph192214706

Objectives: This study aims to explore perspectives and opinions from healthcare professionals and people at risk of type 2 diabetes mellitus (T2DM) to inform the design of PREDIABETEXT, a new digital multifaceted intervention to prevent T2DM. Methods: in this qualitative study, we purposefully recruited 15 healthcare professionals (doctors and nurses) working in primary healthcare centers in Mallorca (Spain), and 15 of their patients at risk of T2DM (HbA1c 6–6.4%, and/or fasting plasma glucose 110–125 mg/dL). We collected the data through semi-structured phone interviews, using an interview guide aimed at gathering participants’ views about the two PREDIABETEXT proposed co-interventions (educational intervention targeted at professionals and delivered as an online training course, and behavioral intervention targeted at individuals at risk of T2DM and delivered using SMS short text messages). The interviews were audio-recorded, verbatim transcribed, and analyzed using a thematic analysis approach. Results: Primary healthcare professionals valued a prediabetes training course for standardizing care and supporting diabetes prevention. They preferred a blended format with content on early detection, intervention, and monitoring. They perceived SMS reminders to their patients as potentially useful for reinforcing guidelines and improving care. Individuals at risk of T2DM, who faced challenges maintaining a healthy diet and exercise routine, viewed SMS as potentially motivational and informative, offering suggestions on content, format, and frequency to enhance its intended benefits. Conclusions: This qualitative study provided valuable insights from primary care professionals and people at risk of T2DM that will inform the user-centered design of the PREDIABETEXT intervention.

Objectives: This study aims to explore perspectives and opinions from healthcare professionals and people at risk of type 2 diabetes mellitus (T2DM) to inform the design of PREDIABETEXT, a new digital multifaceted intervention to prevent T2DM. Methods: in this qualitative study, we purposefully recruited 15 healthcare professionals (doctors and nurses) working in primary healthcare centers in Mallorca (Spain), and 15 of their patients at risk of T2DM (HbA1c 6%-6.4%, and/or fasting plasma glucose 110-125 mg/dl). We collected the data through semi-structured phone interviews, using an interview guide aimed at gathering participants’ views about the two PREDIABETEXT proposed co-interventions (educational intervention targeted to professionals and delivered as an online training course, and; behavioral intervention targeted to patients and delivered using SMS short text messages). The interviews were audio-recorded, verbatim transcribed and analyzed using a thematic analysis approach. Results: Primary healthcare professionals valued a prediabetes training course for standardizing care and supporting diabetes prevention. They preferred a blended format with content on early detection, intervention, and monitoring. They perceived SMS reminders to their patients as potentially useful for reinforcing guidelines and improving care. Patients, who faced challenges maintaining a healthy diet and exercise routine, viewed SMS as potentially motivational and informative, offering suggestions on content, format, and frequency to enhance its intended benefits. Conclusions: This qualitative study provided valuable insights from primary care professionals and patients that will inform the user-centered design of the PREDIABETEXT intervention.

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.

Background: Complications arising from uncontrolled type 2 diabetes mellitus (T2DM) pose a significant burden on individuals’ wellbeing and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition. Aim: To assess the impact of DiabeText, a new theory-based, patient-centred, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management. Design and setting: A pragmatic, phase-three, 12-month, two-arm randomised clinical trial involving primary care patients with T2DM in the Balearic Islands, Spain, including in urban and rural areas. Method: In total, 742 participants with suboptimal glycaemic control (glycated haemoglobin [HbA1c] level >7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. In addition to usual care, the DiabeText group received 167 messages focused on healthy lifestyle and medication adherence. The primary outcome was HbA1c level. Secondary outcomes were: medication possession ratio; health-related quality of life (measured using the EQ-5D-5L questionnaire); diabetes self-efficacy (measured using the Diabetes Self-Efficacy Scale [DSES]); and self-reported adherence to medication, Mediterranean diet (measured using the 14-Item Mediterranean Diet Adherence Screener [MEDAS-14]), and physical activity (measured using the International Physical Activity Questionnaire [IPAQ]). Results: Over the 12-month period, no statistically significant differences in HbA1c were observed between the intervention and the control groups (β = −0.025 [95% confidence interval {CI} = −0.198 to 0.147; P = 0.772]). In comparison with the control group, the DiabeText group showed significant ( P d = 0.35), and EQ-5D-5L (Cohen’s d = 0.18) scores, but not for the rest of the secondary outcomes. Conclusion: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.

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.