Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders
Recruiting · NCT07613008 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Seville
View the official record on ClinicalTrials.gov →Interventions studied
Standard routine maternal careThe e-Perinatal intervention is a personalized mobile health (mHealth) program
What this trial is about
This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- \- Inclusion Criteria (Women)
- Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
- Must be pregnant for at least 11 weeks at the time of enrollment
- Must be at least 18 years old
- Must have access to a mobile phone and internet connection
- Must be able to read, write, and understand Spanish
- Must have a personal email account
- No diagnosis of depression or anxiety disorder at baseline Forma
- \- Inclusion Criteria (Partners or significant others)
- Must receive an invitation to participate from a woman already enrolled in the study
- Must be at least 18 years old
- Must have access to a mobile phone and internet connection
- Must be able to read, write, and understand Spanish
- Must have a personal email account
Exclusion criteria
- Exclusion Criteria (Women)
- Current diagnosis of depression or anxiety disorder
- Receiving psychological or pharmacological treatment for mental health or substance use conditions
- \- Exclusion criteria for partners (or significant others):
- There are no exclusion criteria for partners
Where it is running
2 locations listed.
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo - Mairena del Aljarafe, Sevilla, Spain
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo - Mairena del Aljarafe, Sevilla, Spain