Outcomes

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This study presents the methodology used to perform a Meta-analytic Research Domain (MARD) of preventive interventions for perinatal depression. A huge number of systematic reviews and meta-analyses of randomized control trials (RCTs) focus on preventive interventions for perinatal depression. However, the results are inconclusive, making an urgent need to step up to higher levels of evidence synthesis. The ’Meta-Analytic Research Domain’ (MARD) is a new methodology to aggregate RCT data of a whole field. A MARD is a living systematic review of a research domain that cannot be covered by one PICO. We use MARD design following the PRISMA guidelines. Searchers will be conducted in the following databases: Embase, PubMed, CINHAL and PsycINFO (via EBSCO), Scopus and OpenGrey. RCTs’ studies involving adolescent and adult women who are in the perinatal period will be included. Any type of intervention whose goal is to prevent the incidence of perinatal depression or reduce perinatal depression symptoms will be considered. The updating process will be done regularly in order to detect new available studies. This MARD will show a living updated version of the studies that include interventions to prevent perinatal depression in women. It is expected that the inherent bias of meta-analysis and MARD studies may appear. The major disadvantage of MARDs is that they require considerable resources and research time to build and maintain. The MARD methodology will give a broad overview and identify new research lines in the prevention of perinatal depression. Furthermore, it will facilitate the development of preventive interventions focused on pregnant and postpartum women. This study presents the first and unique MARD focused on the effectiveness of preventive interventions for perinatal depression.

Paternal Perinatal Depression (PPD) is estimated to have an average prevalence of 8% to 13% in fathers during the perinatal period and has a negative impact on fathers’ well-being, family functioning, and child development. The purpose of this systematic review and meta-analysis (SR/MA) was to evaluate the effectiveness of online preventive interventions in non-birthing partners or fathers without depression or other mental disorders. PRISMA-DTA 2020 guidelines were followed. The search for eligible articles was conducted in PubMed, MEDLINE, PubMed, CINAHL Complete, PsycINFO, Scopus and Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), clinicalTrials.gov, Australian New Zealand Clinical Trial Registry, Beacon 2.0 and Psychotherapy Randomized Controlled and Comparative Trials. Grey literature in Opengrey was explored and experts in the field were asked for trial references or published studies. Selected RCTs involved non-birthing partners during the perinatal period (up to 12 months after childbirth). The results were a decrease in postpartum depressive symptoms and/or the incidence of PPD. Using random-effect models, the standardized mean difference (SMD) was computed. Sensitivity analyses were performed. A total of 6 RCTs were included in the SR-MA, conformed by 1752 participants, from five different countries. The pooled SMD was -0.258 [95% confidence interval (CI) -0.513 to -0.004; p < 0.001]. Heterogeneity was moderate (I2=51%). Only two RCTs had an overall low risk of bias. There were no available psychological online interventions delivered only for fathers or non-birthing partners, all were partner inclusive and their effect was not significant. Further RCTs with low risk of bias and specific fathers’ interventions to prevent PPD are needed.

Perinatal mental disorders are common in women, and consequences are multifaceted. Physical activity (PA) promotes mental health during the perinatal period, but few women meet the PA recommendations due to physical symptoms, practical limitations, lack of social support and insufficient knowledge. Despite efforts, prevalence rates have not decreased in the last decades. Several studies underlie the need for personalized prevention integrated into existing maternal and child healthcare policies. In this project, a multicomponent (psychotherapy, PA, healthy habits) mHealth intervention for preventing perinatal mental disorders will be implemented as normalized routine practice in healthcare. The mHealth intervention is characterized by i) coordination with the Andalusian Healthcare System to synchronize the app with usual care visits; ii) weekly content suggestions considering the perinatal stage; iii) content recommendation system based on machine-learning; iv) repository with restricted access considering the perinatal stage; v) community features.

The physical activity module has been designed to promote physical literacy and will be delivered considering the stage of the perinatal period. It comprises 40 educational contents in text or infographic format (22 during pregnancy and 18 during postpartum period) and 104 exercise sessions in video format. Exercise types include aerobics, strength, mobility, and mind-body. Each session lasts 20-35 minutes, structured as warm up, main part and cool down. Exercise intensity is expected to be at a rate of perceived exertion ranging from 3 to 5. All contents are in accordance with evidence-based recommendations for PA during pregnancy and postpartum and are approved by experts in PA during the perinatal period. To enhance adherence, the evidence-based quality of the contents is emphasized, exercise sessions are accessible, and involvement of important others is stimulated.

This project will contribute to the field of mHealth interventions for the promotion of mental health in the perinatal period throughout promoting PA among other components.

Background: The perinatal period might be stressful for fathers, causing increased vulnerability for perinatal mental disorders (PMD). mHealth interventions may prevent PMD, however, the evidence in fathers is scarce. This study, integrated into the e-Perinatal study (ERC starting grant: 101042139), aims to describe the co-design and usability testing processes of an mHealth intervention to prevent PMD in fathers.

 Methods: Thus, a co-design process with end-users (E-U) and healthcare providers (HP) was undertaken, through a mix-method design, that comprised focus group scripts and questionnaires regarding the contents and design of the app. For this, a two-stage iterative consultation was done. Each stage had two focus groups, one with E-U, and another with HP. The qualitative data was analyzed using thematic analysis. The quantitative data was analyzed by simple descriptive statistics. Furthermore, adapted versions of the System Usability Questionnaire (SUS), the user version of the Mobile Application Rating Scale (uMARS), and a demographics questionnaire will be used to assess usability with eight fathers. Quantitative data from the usability testing will be examined by simple descriptive statistics and tests of differences.

 Results: The most relevant themes from the two-stage iterative consultation process were grouped into four main categories: ‘User related constructs’, ‘Program related constructs’, ‘User experience constructs’, and ‘Health care professionals’ factors’. The results indicated that fathers demand male-inclusive contents, regarding their wellbeing and role during the perinatal period. Also, they suggested that men need to be empowered during this period.

 Conclusions: This qualitative study gives insights into fathers’ preferences regarding a user-centered mHealth intervention that aims to prevent PMD. The results enlarge the emerging scientific evidence and interest on how to enhance fathers’ involvement during the perinatal period.

Title. Perinatal mental health of women in the LGBTI community: Experiences and insights on the design of the e-Perinatal app. Background. The perinatal mental health of women belonging to the LGBTI community has been underexplored in research. Additionally, to the best of our knowledge, preventive interventions for perinatal mental health problems have not usually considered the specificities of this population. The aim of this study was twofold: 1) to explore the specific experiences, demands, and needs of women self-identified as part of the LGBTI community during the perinatal period; 2) to re-define and co-design with them the prototype of e-Perinatal app, a mHealth intervention to prevent perinatal mental health problems in women. Methods. This study framed in the European project e-Perinatal (ERC Starting Grant: 101042139). Using a qualitative design, we collected data through focus group and semi structured interviews. Participants are women in the perinatal period self-identified as part of the LGBTI community (three birthing mothers and two non-birthing mothers) and health professionals working with this population. Focus groups and interviews focused on (1) the experiences and needs of these women during the perinatal period, and (2) their opinions on the prototype of the e-Perinatal app, including content of the app, usability, core characteristics, and design. Results. A total of 5 women self-identified as part of the LGBTI community (three birthing mothers and two non-birthing mothers) participated in the focus group. Preliminary analyses suggest some common as well as specific experiences and needs of LGBTI women during their perinatal stage. They also expressed concerns and insights related to the e-Perinatal app, to aspects such as wording and language of contents, the balance between sharing and privacy within the couple, or the inclusion of specific interventions aimed at their unique needs as LGBTI mothers. Conclusions. The specific needs of women in the perinatal period who identify as part of the LGBTI should be considered in the design of preventive interventions.

Introduction: The perinatal period represents a phase of vulnerability for the mother and father. At this stage, a greater risk of suffering from depression and anxiety has been observed, making it necessary to explore factors associated with these problems, such as prenatal risk, the quality of the couple’s relationship, the shared parenting style and attachment. prenatal of the parents. However, the questionnaires developed to evaluate these constructs have been developed in Anglo-Saxon populations, with no Spanish versions existing. Objective: To translate and culturally adapt the Antenatal Risk Questionnaire-Revised (ANRQ-R), Parental Antenatal Attachment Scale (PAAS), Quality of Marriage Index (QMI), and Coparenting Relationship Scale (CRS) for use by mothers and Spanish parents in the perinatal period. Method: The reverse translation method was used following Beaton’s guidelines. The original questionnaires were translated into Spanish by two independent researchers. A third reviewer was responsible for the back translation. Finally, the original version and the version translated into English were compared. The translated and adapted versions into Spanish were reviewed by a committee of experts (n = 4), following the guidelines of Hambleton and Zeneski. Results: The translated and adapted versions into Spanish did not present any discrepancies during the back-translation process, except for items 2 (ANRQ-R), 4 (QMI) and 8 (CRS). After the evaluation process by the expert committee, 12 items (54%) of the ANRQ, 1 item (16.7%) of the QMI, 10 items (71.42%) of the CRS and 4 items (25%) of the PAAS received suggestions from improvement. Conclusions: The Spanish versions of the ANRQ-R, QMI, CRS and PAAS questionnaires were obtained for use in mothers and fathers in the perinatal period. In the future, the psychometric properties of the Spanish versions generated should be examined.

This study aims to co-design and develop, together with the involvement of the stakeholders, an innovative personalized mHealth app called e-Perinatal for psychological intervention to prevent perinatal mental health disorders (depression and anxiety) in maternal health care. This project is framed in a European funded project (ERC grant). The sector will be the usual maternal health care programme framed in the public primary health care centres in available in the public health care services of the Andalusian Region in Spain. We will employ an iterative mixed-methods design to co-design, produce, and test a prototype of the e-Perinatal app, according to stakeholders’ preferences. We will follow these three phases: 1) A prototype of the e-Perinatal app (beta version) will be designed with a healthcare software development company. 2) The prototype will be refined via a co-design process with 144 local stakeholders. 3) Usability testing will be undertaken with 8 pregnant/postpartum women and 8 fathers/partners from phase 2. Framework analysis and quantitative data from usability testing by simple descriptive statistics and tests of differences will examine qualitative data. We will co-design with stakeholders the ‘e-Perinatal app’, an innovative and personalized mHealth psychological intervention for universal prevention of maternal PMD, to be provided by health professionals to women and their partners for use throughout the entire perinatal period. We will test the feasibility and effectiveness of the ‘e-Perinatal app’ in two real-world trials in routine maternal health care practice for the prevention of perinatal mental health disorders.

In the current context, mobile-health interventions (mHealth), developed and examined for use without the need for direct human support, can be an affordable way to provide universal primary prevention of perinatal mental disorders worldwide. This study aims to co-design and develop an innovative, multicomponent, and personalized mHealth app called e-Perinatal to prevent perinatal mental health disorders (depression and anxiety) in maternal health care for being implemented in two real-world trials, as normal routine practice. This project is frame in a European funded project (e-Perinatal ERC Starting Grant). It will be employed an iterative mixed-methods design to co-design, produce, and test a prototype of the e-Perinatal app, according to stakeholders’ preferences. We will follow these three phases: 1) A prototype of the e-Perinatal app (beta version) will be designed with a healthcare software development company. 2) The prototype will be refined via a co-design process, by focus groups, with 144 local stakeholders. 3) Usability testing will be undertaken with 8 pregnant/postpartum women and 8 fathers/partners from phase 2. Qualitative data will be examined by framework analysis and quantitative data from usability testing by simple descriptive statistics and tests of differences, both will be triangulated. The participants will be asked for feedback for both content (micro-intervention sessions and information provided) and design (what features they found most useful, preferences for phrasing, wording, graphics, colors, and type of badge tier system). The different profiles of stakeholders included by means of theoretical sampling will enhance the discourse variability and will represent different groups. The results derived from the co-design analyses, are expected to improve the feasibility of the prototype of the e-perinatal app, in the pilot randomized controlled trial.

The ‘e-Perinatal’ project aims to generate scientific evidence to establish the effectiveness of universal preventive interventions for perinatal mental disorders and their implementation as normalized routine practice in health care services. Patient and public involvement (PPI) in research is imperative for analysis of the implementation from a range of perspectives and to ensure the implementation is tailored appropriately to the local sociocultural context. The study aims to design, develop, and evaluate PPI in the e-Perinatal project. PPI will be involved in the conduct, reporting, and dissemination plans of this research, following the first international guide for reporting PPI in health and social care research (GRIPP-2 long form), in accordance with the INVOLVE principles. The ‘toolkit’ for PPI in clinical trials, developed by Bagley et al. (2016), will be used to monitor, train and support involvement in the different phases of the research project. The research meetings and PPI decisions will be documented. A mixed method, an online survey, and semi-structured interviews, will be used to assess the impact on people (i.e., research team, patients, and health care professionals). Also, it will be assessed the impact of PPI on research (i.e., changes made in the intervention program, and effectiveness of the intervention). It is expected that PPI will keep this research relevant for patients and carers since their perspectives are being considered in the conduct, reporting, and dissemination plans. Furthermore, the usage of the GRIPP-2 checklist, as well as the impact assessments (i.e., on people and on research), will give insights into how PPI can enhance the effectiveness and implementation process of evidence-based interventions. To the best of our knowledge, the e-Perinatal study will be the first to evaluate the PPI for the effectiveness and implementation of perinatal mental health prevention programs in health care services.