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.

Emotional dysregulation (ED) is a transdiagnostic variable underlying various psychiatric disorders, including addictive behaviors (ABs). This meta-analysis examines the relationship between ED and ABs (alcohol, tobacco, cannabis, gambling, and gaming), and indicators of AB engagement (frequency, quantity/time of use, severity, and problems). Searches were conducted in PubMed, Scopus, WoS, and PsycINFO. Five separate meta-analysis were run using random-effects models. Moderators (age, sex, continental region, and sample type; community vs. clinical), and publication bias were evaluated. A total of 189 studies (N = 78,733; 51.29 % women) were identified. ED was significantly related to all ABs. Problems and severity indicators exhibited the largest effects (r’s .118-.372, all p <.023). There were larger effect sizes for cannabis problems (r = .372), cannabis severity (r = .280), gaming severity (r = .280), gambling severity (r = .245), gambling problems (r = .131), alcohol problems (r = .237), alcohol severity (r = .204), and severity of nicotine dependence (r = .118). Lack of impulse control exhibited some of the largest effects in relation to ABs. Clinical samples of cannabis users vs. community-based exhibited larger magnitude of associations. Interventions targeting ABs should address lack of strategies and impulsive behaviors as an emotion regulation strategy specifically, as it is a common risk factor for ABs.

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.

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: 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 <0.05) improvements in self-reported medication adherence (odds ratio = 1.4; 95% CI = 1.0 to 1.9), DSES (Cohen’s 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.