NCT06871397 Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy
| NCT ID | NCT06871397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Rovira i Virgili |
| Condition | Prenatal Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 228 participants in total. It began in 2025-04-03 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to develop and implement a preventive intervention through a mobile application to help pregnant women feel better emotionally and cope with the changes of pregnancy in a more positive way. The idea is to offer practical and accessible tools that allow them to better manage stress, emotions and preparation for motherhood. The intervention proposed in this study is based on psychological strategies that have proven to be effective, such as relaxation exercises, techniques to manage stress and strategies to improve mood, strengthen the relationship with the partner and foster the bond with the baby before its birth. The application is designed to accompany pregnant women from the beginning of pregnancy to the postpartum period. It has different programs that include weekly activities on various important topics, such as physical health care, emotional management, connection with the baby during pregnancy, preparation for childbirth and the first months of the newborn's life. To evaluate the effectiveness of this tool, a study will be carried out with pregnant women treated by the Catalan Health Service. Participants will be randomly assigned to one of two study groups: the experimental group (in which participants, in addition to the usual medical care offered during pregnancy, will have access to the programs and activities of the app organized in a weekly plan of 5 activities and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum) or the control group (in which participants will receive the usual medical care offered during pregnancy, but will not have access to the programs and activities of the app and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum). Women who use the app are expected to experience greater emotional well-being and a lower risk of developing mental health problems during pregnancy. In addition, they may feel more prepared for motherhood, take better care of their health, have a more positive birth experience and a lower risk of postpartum depression. These women are also expected to develop a stronger bond with their baby and adapt better to the new stage of motherhood.
Eligibility Criteria
Inclusion Criteria: * Pregnant women * Pregnancy of less than 15 weeks of gestation * More than 18 years old age * Able to read, write, and understand Spanish * In possession of a smartphone * Able to manage smartphone apps * Have signed a written informed consent document Exclusion Criteria: * Having a high-risk pregnancy that entails transfer to another specialized health centre * Having diagnosis of disease that may affect the central nervous system, such as brain pathology or traumatic brain injury * Having other psychiatric diagnosis or acute psychiatric illness, such as substance dependence or abuse, a presence of schizophrenia or other psychotic disorders or risk for suicide * To be under psychopharmacological medication or under psychopharmacological treatment.
Contact & Investigator
Carmen Hernández Martínez, Doctor
PRINCIPAL INVESTIGATOR
University Rovira i Virgili
Frequently Asked Questions
Who can join the NCT06871397 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Prenatal Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06871397 currently recruiting?
Yes, NCT06871397 is actively recruiting participants. Contact the research team at carmen.hernandez@urv.cat for enrollment information.
Where is the NCT06871397 trial being conducted?
This trial is being conducted at Reus, Spain.
Who is sponsoring the NCT06871397 clinical trial?
NCT06871397 is sponsored by University Rovira i Virgili. The principal investigator is Carmen Hernández Martínez, Doctor at University Rovira i Virgili. The trial plans to enroll 228 participants.
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