Actively Recruiting
Led by University Rovira i Virgili · Updated on 2025-07-17
228
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are evaluating a biopsychosocial cognitive-behavioral intervention delivered via a smartphone app to improve emotional well-being and mental health in pregnant women. The study focuses on helping women manage stress, emotions, and prepare for motherhood positively during pregnancy and postpartum. This randomized clinical trial compares the app-based intervention with standard prenatal care to assess its impact on mental health, birth outcomes, and maternal adaptation. The intervention group will use a mobile application offering 10 weekly modules from weeks 16 to 36 of pregnancy. These modules include relaxation, mindfulness, stress management, prenatal attachment, childbirth preparation, and newborn care. Both groups receive usual prenatal care, including emotional distress screening. The control group does not access the app but completes the same study questionnaires at weeks 16 and 36 of pregnancy and postpartum. Participants will complete questionnaires assessing well-being, anxiety, depression, prenatal bonding, and parental stress at baseline, post-intervention, and postpartum. The app usage frequency will be monitored to evaluate daily emotional states. Researchers will also track secondary outcomes such as healthy lifestyle habits, pregnancy length, birth type, and infant birth weight. The study includes safety monitoring and aims to support long-term maternal and child health through early psychological intervention.
CONDITIONS
Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From week 16 to week 36 of pregnancy
Participants in the experimental group engage with a biopsychosocial cognitive-behavioral digital intervention delivered via a smartphone app, designed to promote well-being and mental health during pregnancy. The intervention includes 10 modules covering mindfulness, stress management, prenatal attachment, childbirth preparation, and postpartum adaptation. Participants in both groups receive routine prenatal care including emotional screening.
Routine prenatal visits and digital intervention accessed independently by participants
Duration - Up to 45 days postpartum
Participants are evaluated postpartum to assess mental health, well-being, and obstetric outcomes including birth complications and neonatal health.
1 visit at approximately 45 days postpartum and 1 visit at approximately 10 days postpartum for birth outcomes
Total: 1 location
1
Centre d'Atenció Primària Sant Pere
Reus, Tarragona, Spain, 43202
Actively Recruiting
C
Carmen Hernández Martínez, Doctor
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Carmen Hernández-Martínez, Josefa Canals-Sans, Demetria Patricio...
https://pubmed.ncbi.nlm.nih.gov/41390643