Online biopsychosocial program to improve mental well-being during pregnancy
Official title: Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy: A Randomized Clinical Trial
Run by University Rovira i Virgili · NCT06871397 · Data updated 2026-11-12
This trial tests whether a smartphone app with relaxation, stress‑management and mood‑boosting exercises can help pregnant Spanish‑speaking women early in pregnancy feel less anxious and more prepared for motherhood.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 228 (estimated) |
| Sponsor | University Rovira i Virgili Academic / other |
| Locations | 1 site (Reus, Tarragona) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | April 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | July 17, 2025 |
| Trial ID | NCT06871397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women under 15 weeks' gestation who are over 18, can read and use Spanish and own a smartphone, without high‑risk pregnancy or severe psychiatric disorders, are ideal candidates.
✕Probably not a fit
Women with high‑risk pregnancies, central nervous system disease, active substance dependence, psychotic disorders, suicide risk, or those taking psychotropic medication are excluded and unlikely to benefit from this preventive app.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The intervention is a mobile application delivering a biopsychosocial, CBT‑informed program with weekly activities from early pregnancy through the postpartum period. Content includes relaxation exercises, stress management techniques, mood improvement strategies, partner relationship strengthening, and activities to foster prenatal bonding. Eligible participants are pregnant women under 15 weeks' gestation, over 18, Spanish‑literate, and able to use a smartphone, while those with high‑risk pregnancies or severe psychiatric illness are excluded. The trial tracks emotional well‑being, symptoms of anxiety and depression, and related obstetric and postpartum outcomes to test the app's preventive effects.
Why it matters
Potential benefit: If successful, the app could reduce prenatal anxiety and depressive symptoms and lower the risk of postpartum mental health problems while offering an accessible preventive tool.
How similar studies have gone: Similar digital CBT and psychoeducation programs for perinatal mental health have shown moderate success in reducing prenatal anxiety and depression, though effect sizes and long‑term benefits vary across studies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Centre d'Atenció Primària Sant Pere
Reus, Tarragona, Spain Recruiting
Study contacts
- Principal investigator: Carmen Hernández Martínez, Doctor — University Rovira i Virgili
- Study coordinator: Carmen Hernández Martínez, Doctor
- Email: carmen.hernandez@urv.cat
- Phone: +34675245881
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.