+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Search Bar & Filters

Found 3 Actively Recruiting clinical trials

E

Actively Recruiting

Healthy Volunteer

Researchers are evaluating a personalized mobile health mHealth program called e-Perinatal designed to prevent maternal perinatal depression and anxiety disorders. This large-scale, cluster randomized controlled trial also explores effects on paternal mental health and child development, as well as how well the intervention can be implemented in real-world primary healthcare settings. The study is part of the ERC-funded e-Perinatal project and takes place in routine maternal care environments within primary healthcare centers. Participants are grouped by primary healthcare centers randomized to either receive the e-Perinatal intervention or continue with usual maternal care. Those in the intervention group get access to the e-Perinatal app, which offers digital micro-interventions in psychological support, physical activity, and healthy lifestyle, a personalized recommendation engine, social support features, mental health monitoring, an SOS button for assistance, and appointment reminders. The app is used from recruitment during pregnancy until 12 months postpartum. The control group receives standard maternal care including routine antenatal and postnatal visits and maternal education programs. During the study, participants will be assessed through structured diagnostic interviews to measure the cumulative incidence of maternal perinatal depression and anxiety disorders at baseline and 12 months postpartum. Maternal and paternal mental health symptoms, psychological wellbeing, and child development will be evaluated at multiple points including late pregnancy and several postpartum months. The study also tracks implementation outcomes like acceptability, feasibility, adoption, fidelity, and barriers in healthcare settings. Participation lasts from pregnancy through 12 months postpartum with regular mental health and wellbeing assessments.

Age: 18Years +All GendersPhase Not Applicable
1 location
E

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the feasibility, acceptability, and preliminary effectiveness of an early diagnosis detection and referral strategy for mental health disorders during the perinatal period. This study is embedded within a larger cluster randomized trial focusing on maternal perinatal depression and anxiety disorders. It also aims to validate and implement an Artificial Intelligence-based algorithm for early screening in routine maternal care. Participants will use the e-Perinatal app, a personalized mobile health program that offers digital micro-interventions on psychological health, physical activity, healthy lifestyle, social support, mental health monitoring, an SOS assistance button, and appointment reminders. The app is integrated into routine maternal care and used from recruitment during pregnancy until 12 months postpartum. The study compares this intervention with standard routine maternal care provided by the public healthcare system. During the study, data will be collected through questionnaires, clinical records, and interviews with participants and healthcare professionals. Researchers will measure the feasibility and acceptability of the referral strategy, identify at-risk participants, track referral timing and engagement with specialized mental health services. The study lasts from recruitment through an average of 18 months, covering baseline to 12 months postpartum with ongoing follow-up to assess outcomes.

Age: 18Years +FEMALEPhase Not Applicable
1 location
P

Actively Recruiting

Researchers are evaluating a personalized mobile health mHealth intervention called the e-Perinatal app designed to prevent perinatal mental disorders in pregnant and postpartum women and their partners. This pilot study is part of the e-Perinatal project funded by the European Research Council and follows recommended phases for developing complex interventions. The study aims to assess feasibility, acceptability, and preliminary effectiveness within routine maternal care settings in Andalusia, Spain. Participants will be assigned by cluster randomization of primary healthcare centers to either the intervention or control group. The intervention group will use the e-Perinatal app for two months alongside standard maternal care. The app includes psychoeducational content, video-guided physical activities, mindfulness exercises, mood tracking, personalized recommendations, and social features. Healthcare professionals in this group receive special training to support app integration. The control group will receive standard maternal care and monthly psychoeducational emails about perinatal mental health and infant development. During the study, participants will be assessed at enrollment and two months later, with follow-up one month after that. Researchers will evaluate feasibility, acceptability, adoption, fidelity, and early indicators of effectiveness such as depressive and anxiety symptoms in women and their partners, and infant health outcomes. Data collection includes mood symptoms, well-being measures, and postnatal stress. The study will inform the design of a larger trial to evaluate effectiveness and cost-effectiveness of this intervention integrated into routine care.

Age: 18Years +All GendersPhase Not Applicable
1 location